How new opiate treatment clinic operates in Redding – KRCRTV.COM
How new opiate treatment clinic...
REDDING, Calif. - Opiate treatment clinic Aegis has opened their Redding location for two weeks and opened its doors for a tour.
When word first came that the clinic was going to open, people were concerned that it might turn the area into a crime magnet.
However, business owners said the loitering problem has actually gotten better.
The clinic looked like any doctor's office, with a waiting room, complimentary treats and coffee.
The clients of the clinic are there to get help with their drug addiction.
ChicoClinic Manager Michelle Saldana said so far, there have been no complaints.
"We have gotten good reports from our neighbors. We still have a clinic concierge on site, and he's monitoring the parking lot, as well as helping patients get acquainted with the area," Saldana said.
However, some are skeptical about using methadone to treat opioid addiction, concerned with treating one addiction with another drug.
"Methadone doesn't drop the dopamines into the pleasure hormone system, like heroin, or even Vicodin. It doesn't give that euphoria, so the individual doesn't get that high," said assistant clinic manager Daniel Moore.
Methadone is used to help those addicted to opiates manage withdrawal symptoms.
The process at the clinic is quick. Patients are usually in and out in five minutes.
"Our patients will come in, and check in at the front desk. We do take random urine analysis. Patients would go to the dispensing window here, and they would put their fingerprint on their fingerprint reader to ensure that we're giving the right medication to the right patient. They're given their medication, our dosing nurse checks in with them, make sure they're good for the day," Saldana said.
Patients also have to travel to the Aegis clinic inChico once a week for counseling.
"Addiction isn't just the medical component, it takes a lot of counseling as well, and that's where majority of the recovery happens," Saldana said.
They are hoping to expand the clinic in Redding to include counseling services, so patients in Shasta County won't have to make that weekly trip to Chico.
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Could Be the Thyroid; Could Be Ennui. Either Way, the Drug Isn’t Helping. – New York Times
New York Times | Could Be the Thyroid; Could Be Ennui. Either Way, the Drug Isn't Helping. New York Times It's a strong signal that this is an overused medication, said Dr. Juan Brito, an endocrinologist at the Mayo Clinic. Some people really need this medicine, but not the vast majority of people who are taking it. A primer: ... Usually, doctors order ... |
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A 3D-printed patch for a ‘broken’ heart – Livemint
This week: Biomedical engineering division, University of Minnesota
Three-dimensional or 3D printing technology, which has been around for almost three decades, routinely makes headlines. Not surprising, given that the so-called Fabbers, or personal manufacturing machines3D printers come under this categorynow not only make jewellery and toothbrushes, but also football boots, racing-car parts, custom-designed cakes, guns, human organs, houses and plane parts.
3D printing can be used to save lives too. Consider this. During a heart attack, the muscle cells of the heart do not get enough blood. Hence, they die. Our bodies cant replace these dead cells, so the body leaves a scar tissue in that area of the heart. This puts the person at risk of heart failure in the future.
A team of biomedical engineering researchers, led by the University of Minnesota (Umn.edu), has created a laser 3D-bioprinted patch to address the issue and help heal the scarred heart tissue after a heart attack. Three-dimensional bioprinting is the process of creating cell patterns in a confined space using 3D printing technologies.
The researchers successfully used this technique to incorporate stem cells (cells capable of renewing themselves through cell division, sometimes after long periods of inactivity) derived from adult human heart cells in a dish in the lab.
When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from stem cells and structural proteins (that do most of the work in cells and are required for the structure, function, and regulation of the bodys tissues and organs) belonging to the heart, it became part of the heart and was absorbed into the body, requiring no further surgeries.
The discovery, which is a major step forward in treating patients with tissue damage after a heart attack, was published on 14 April in Circulation Research, the journal published by the American Heart Association. The researchers have filed a patent for it.
The scientists insist that this research is different from previous ones in that the patch is modelled after a digital, 3D scan of the structural proteins of the heart tissue. The digital model is made into a physical structure by 3D printing, further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type, explain the researchers, can we achieve the 1 micron resolution needed to mimic structures of native heart tissue.
The scientists say they are already beginning the next step to develop a larger patch that they will test on a pig heart, which is similar in size to a human heart. Of course, the real success will be known only when human trials take place.
3D printing belongs to a class of techniques known as additive manufacturing, or building objects layer by layer. The most common household 3D-printing process involves a print head, which allows for any material to be extruded or squirted through a nozzle. There are several additive processes, including selective laser sintering, direct metal-laser sintering, fused deposition modelling, stereolithography and laminated-object manufacturing. All of them differ in the way layers are deposited to create the 3D objects.
Meanwhile, the concept of 4D printing, which allows materials to self-assemble into 3D structures, and was initially proposed by Skylar Tibbits of the Massachusetts Institute of Technology (MIT) in April 2013, is also showing promise.
Lab Watch is the Lounge guide to emerging tech from around the world .
First Published: Fri, Apr 21 2017. 02 57 PM IST
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Multiple Sclerosis patient successfully treated with bone marrow transplant – Business Standard
In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved
IANS | New Delhi April 21, 2017 Last Updated at 05:00 IST
A team of doctors in New Delhi has successfully treated a 24-year-old girl suffering from Multiple Sclerosis (MS) with bone marrow transplant (BMT).
Kanika Juneja was diagnosed with MS an autoimmune disorder where the body's immune system starts attacking the protective sheet covering the nerve cells in the brain and the spinal cord.
She went through several rounds of treatments but could not be cured. Juneja got another chance at life at Fortis Healthcare where the doctors treated her with BMT.
"In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved. Chemotherapy is then administered to reset the body's immunity and then the stem cells are injected back to rescue the person from the side effects of chemotherapy. After the surgery, the patient is kept under isolation for a few months to ensure he/she does not contract any infection," explained Dr Rahul Bhargava, Director, Clinical Hematology and Bone Marrow Transplant, Fortis Memorial Research Institute (FMRI).
Since conventional steroid injections and immune therapy are expensive and don't promise a cure, Bhargava thought of going for a BMT for Juneja.
Juneja is now actively involved in raising awareness about MS amongst the community through social media.
"I had just completed my college education when I was diagnosed with multiple sclerosis. I was lucky because I got diagnosed within a week of my symptoms and could avail treatment options faster," Juneja said.
"In this case, we have proved that bone marrow transplant can be seen as a successful alternate treatment option for multiple sclerosis patients, giving them a fresh shot at life," added Dr Simmardeep Singh Gill, Zonal Director, FMRI, in a statement.
Currently, there are 2.3 million people living with multiple sclerosis worldwide.
A team of doctors in New Delhi has successfully treated a 24-year-old girl suffering from Multiple Sclerosis (MS) with bone marrow transplant (BMT).
Kanika Juneja was diagnosed with MS an autoimmune disorder where the body's immune system starts attacking the protective sheet covering the nerve cells in the brain and the spinal cord.
She went through several rounds of treatments but could not be cured. Juneja got another chance at life at Fortis Healthcare where the doctors treated her with BMT.
"In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved. Chemotherapy is then administered to reset the body's immunity and then the stem cells are injected back to rescue the person from the side effects of chemotherapy. After the surgery, the patient is kept under isolation for a few months to ensure he/she does not contract any infection," explained Dr Rahul Bhargava, Director, Clinical Hematology and Bone Marrow Transplant, Fortis Memorial Research Institute (FMRI).
Since conventional steroid injections and immune therapy are expensive and don't promise a cure, Bhargava thought of going for a BMT for Juneja.
Juneja is now actively involved in raising awareness about MS amongst the community through social media.
"I had just completed my college education when I was diagnosed with multiple sclerosis. I was lucky because I got diagnosed within a week of my symptoms and could avail treatment options faster," Juneja said.
"In this case, we have proved that bone marrow transplant can be seen as a successful alternate treatment option for multiple sclerosis patients, giving them a fresh shot at life," added Dr Simmardeep Singh Gill, Zonal Director, FMRI, in a statement.
Currently, there are 2.3 million people living with multiple sclerosis worldwide.
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Preventing Graft-Versus-Host Disease in Stem Cell Transplant Recipients – Genetic Engineering & Biotechnology News (press release)
An international group of scientists led by investigators at the Technical University of Munich (TUM) says it has discovered molecular mechanisms that might prevent the development ofgraft-versus-host disease (GVHD) in individuals receiving stem cell transplants.
During GVHD, transplanted stem cells become T lymphocytes, which are supposed to fight intruders such as bacteria. Instead, they start attacking the recipients already weakened body.
Researchers from TUM and theMemorial Sloan Kettering Cancer Center published a study ("RIG-I/MAVS and STING Signaling Promote Gut Integrity during Irradiation- and Immune-Mediated Tissue Injury")in Science Translational Medicine that provides details on how to prevent the development of GVHD.
The attacks by the T cells primarily affect the skin, liver, and, in particular, the gastrointestinal tract. The intestine is believed to be the key organ where GVHD starts. The drug treatment and radiation involved in stem cell transplants damage epithelial cells, which form part of the intestinal mucosal layer. Stress signals emitted by the dying epithelial cells and the arrival of intestinal bacteria in the previously germ-free areas of the gut due to the loss of the epithelium trigger the activation of aggressive donor T cells.
"If the epithelium could be protected or quickly restored, the risk of an immune response would be much lower," says Hendrik Poeck, M.D., Ph.D., who, along with Tobias Haas, M.D., heads a research group at the third medical clinic of TUM's Klinikum rechts der Isar. "Up to now, however, there have been very few treatment strategies that seek to regenerate the epithelium."
The scientists working with Dr. Poeck studied two proteins produced naturally in the body and known for their role in fighting bacteria and viruses: RIG-I (retinoic acid-inducible gene I) and STING (stimulator of interferon genes). "We were able to demonstrate for the first time that both of them can also be used to bring about a regenerative effect," notes Julius Fischer, first author of the study.
Both proteins are part of signal chains that cause type I interferon (IFN-I) to be produced. IFN-I triggers many different immune responses, but can also speed up the replacement of epithelial cells.
The RIG-I signal pathway can be deliberately stimulated using triphosphate-RNA (3pRNA). Poeck and his team were able to demonstrate in mice that 3pRNA can indeed protect the epithelial cells. Timing is critical. Measurable protection was only seen when the 3pRNA was administered exactly 1 day before the start of radiation and drug treatment.
"We assume that after just 1 day of treatment, there would no longer be enough intact epithelial cells in the gut for the RIG-I/IFN signal path to function," explains Haas. Although fewer activated T cells were generated after a treatment with 3pRNA, the positive effect of the leukemia therapy was not reduced to a measurable degree.
Both RIG-I agonists, such as 3pRNA, and STING agonists are currently in clinical development. The research points to a wide range of potential applications, especially in the treatment of tumors.
"Our study shows that regenerative processes can also be triggered through selective activation of these signal paths," adds Poeck. "It thus appears quite possible that these selective agonists will be administered in the future to patients who are candidates for allogeneic stem cell transplants. However, further studies will be needed to learn how they actually work before applications in human medicine are possible."
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Using CRISPR to Reverse Retinitis Pigmentosa and Restore Visual … – Newswise (press release)
Newswise Using the gene-editing tool CRISPR/Cas9, researchers at University of California San Diego School of Medicine and Shiley Eye Institute at UC San Diego Health, with colleagues in China, have reprogrammed mutated rod photoreceptors to become functioning cone photoreceptors, reversing cellular degeneration and restoring visual function in two mouse models of retinitis pigmentosa.
The findings are published in the April 21 advance online issue of Cell Research.
Retinitis pigmentosa (RP) is a group of inherited vision disorders caused by numerous mutations in more than 60 genes. The mutations affect the eyes photoreceptors, specialized cells in the retina that sense and convert light images into electrical signals sent to the brain. There are two types: rod cells that function for night vision and peripheral vision, and cone cells that provide central vision (visual acuity) and discern color. The human retina typically contains 120 million rod cells and 6 million cone cells.
In RP, which affects approximately 100,000 Americans and 1 in 4,000 persons worldwide, rod-specific genetic mutations cause rod photoreceptor cells to dysfunction and degenerate over time. Initial symptoms are loss of peripheral and night vision, followed by diminished visual acuity and color perception as cone cells also begin to fail and die. There is no treatment for RP. The eventual result may be legal blindness.
In their published research, a team led by senior author Kang Zhang, MD, PhD, chief of ophthalmic genetics, founding director of the Institute for Genomic Medicine and co-director of biomaterials and tissue engineering at the Institute of Engineering in Medicine, both at UC San Diego School of Medicine, used CRISPR/Cas9 to deactivate a master switch gene called Nrl and a downstream transcription factor called Nr2e3.
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, allows researchers to target specific stretches of genetic code and edit DNA at precise locations, modifying select gene functions. Deactivating either Nrl or Nr2e3 reprogrammed rod cells to become cone cells.
Cone cells are less vulnerable to the genetic mutations that cause RP, said Zhang. Our strategy was to use gene therapy to make the underlying mutations irrelevant, resulting in the preservation of tissue and vision.
The scientists tested their approach in two different mouse models of RP. In both cases, they found an abundance of reprogrammed cone cells and preserved cellular architecture in the retinas. Electroretinography testing of rod and cone receptors in live mice show improved function.
Zhang said a recent independent study led by Zhijian Wu, PhD, at National Eye Institute, part of the National Institutes of Health, also reached similar conclusions.
The researchers used adeno-associated virus (AAV) to perform the gene therapy, which they said should help advance their work to human clinical trials quicker. AAV is a common cold virus and has been used in many successful gene therapy treatments with a relatively good safely profile, said Zhang. Human clinical trials could be planned soon after completion of preclinical study. There is no treatment for RP so the need is great and pressing. In addition, our approach of reprogramming mutation-sensitive cells to mutation-resistant cells may have broader application to other human diseases, including cancer.
Co-authors include: Jie Zhu and Xin Fu, Guangzhou Women and Childrens Medical Center; Chang Ming, Duc Ahn Hoang and Wenjun Xiong, City University of Hong Kong; Yaou Duan, Jeffrey Rutgard, Runze Zhang, Wenqui Wang, Daniel Zhang, Edward Zhang and Charlotte Zhang, Shiley Eye Institute, Institute for Engineering in Medicine and Institute for Genomic Medicine, UC San Diego; Rui Hou, Guangzhou KangRui Biological Pharmaceutical Technology Company; Xiaoke Hao, Fourth Military Medical University; and the Eye Gene Therapy Consortium.
Funding for this research came, in part, from the Richard Annesser Fund, the Dick and Carol Hertzberg Fund, the National Basic Research Program of China, Hi-Tech Research and Development Program of China, Hon Kong General Research Fund and Early Career Scheme and Shenzhen Science and Technology Fund.
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3D-printed Patch Can Help Mend a ‘Broken’ Heart – Technology Networks
Technology Networks | 3D-printed Patch Can Help Mend a 'Broken' Heart Technology Networks The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to ... |
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Surprise – Lungs Make Blood, Too – Newsmax
Scientists at the University of California San Francisco have discovered a new function of lungs: They make blood which leads to a new wellspring of stem cells as well.
The astonishing breakthrough comes courtesy of refinement to microscopic video imaging that allows researchers to probe individual cells within blood vessels of a living host's lungs in this case, mice lungs.
The findings have far-reaching implications for human study: Researchers were surprised to find that not only did the lungs produce more blood cells, they did so in volumes that indicated more than half of all platelets in circulation critical for clotting are produced by the lungs.
The significance for the blood stem cells also was compelling. The newly discovered pool of stem cells is capable of restoring blood production when bone marrow stem cells are depleted. This could lead to novel approaches to treating leukemia, a cancer of white blood cells that crowds out red blood cells, and bone cancer, which destroys the body's ability to manufacture red blood cells.
This finding definitely suggests a more sophisticated view of the lungs that theyre not just for respiration but also a key partner in formation of crucial aspects of the blood, said pulmonologist Mark R. Looney, a professor of medicine and of laboratory medicine at the University of California, and the research's senior author. What weve observed here in mice strongly suggests the lung may play a key role in blood formation in humans as well. The report was published online at Nature.com.
The new imaging approach allowed scientists to examine interactions between the immune system and platelets in the lungs. While following the interactions, they discovered a surprisingly large population of cells that produce platelets called megakaryocytes. Though these cells were observed in the lungs previously it was generally though that they exist primarily in bone marrow.
Researchers were baffled and more detailed imaging followed. Once they zeroed in on these cells, they soon realized that they not only took up residence in the lungs, they also were producing 10 million platelets per hour there evidence that more than half of platelet production actually occurs in the lungs (in the mice models).
To be able to track blood stem cells and blood production, researchers transplanted donor lungs to mice with fluorescent-dye-tinted megakaryocytes. They followed the fluorescent cells as they traveled to the new lungs.
In another experiment, scientists wanted to determine if lungs that already had these platelet producers imbedded would spur platelet production in mice with low platelet counts, so they transplanted lungs with fluorescent-tinted megakaryocytes into mice predetermined to have low platelet counts. The transplanted lungs quickly sprung into action and restored normal platelet levels.
In yet another experiment, researchers transplanted healthy lungs with all cells fluorescently tinted into mice without bone marrow blood stem cells. The fluorescent marker cells quickly traveled to the damaged bone marrow and began production of myriad cells including T cells, which are key immune cells.
The exact mechanism behind the bone marrow-lung blood production is not yet known. Its possible that the lung is an ideal bioreactor for platelet production because of the mechanical force of the blood, or perhaps because of some molecular signaling we dont yet know about, said Guadalupe Ortiz-Muoz, a postdoctoral researcher and the researchs co-author. But more research is sure to follow.
Now medical scientists and researchers can zero in on proving in human models that blood components stem cells key among them travel more freely than previously though, which could lead ultimately to advances in treatment options for various blood disorders.
2017 NewsmaxHealth. All rights reserved.
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David Steenblock, D.O., Uses Stem Cells and Other Therapies for Stroke Patients – GlobeNewswire (press release)
April 20, 2017 07:00 ET | Source: David Steenblock, D.O. Inc.
SAN CLEMENTE, Calif., April 20, 2017 (GLOBE NEWSWIRE) -- David Steenblock, an osteopathic physician based in San Clemente, CA, uses stem cells and other therapies to achieve significant and improved lifestyle outcomes for many stroke patients.
Many of our cases have demonstrated improved mobility for stroke victims who received stem cell therapy, along with other therapies, including chelation and hyperbaric oxygen, says Dr. Steenblock.
One patient who suffered a stroke several years ago, came to Dr. Steenblocks clinic to undergo the full stroke program. This included EDTA chelation, a procedure that removes heavy metals from the blood, and hyperbaric oxygen therapy, along with stem cells from his bone marrow to effect healing and restoration.
After having the bone marrow stem cells, the patients eyesight improved, and both of his knees, which hadnt been working well, were back to functioning almost normally. In addition, his hip joint went back to normal function and he believes his balance when walking has improved tremendously.
The EDTA Chelation Therapy, a treatment used to remove heavy metals from the blood, was used with hyperbaric oxygen, which can lead to significant neurologic improvements for stroke patients.
Dr. David Steenblock is a leading-edge physician in many fields of medicine, from stroke care, to acute brain trauma, to generative and cell-based medicine in the treatment of ALS, Cerebral Palsy and other chronic and degenerative diseases. For more information about Dr. Steenblocks work in stem cell therapies, visit http://www.stemcellmd.org
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The Go-To Gene Sequencing Machine With Very Strange Results – WIRED
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Doctors successfully treat 24-year-old girl MS patient with bone marrow transplant – Zee News
New Delhi: 24-year-old girl, Kanika Juneja, suffering from Multiple Sclerosis (MS) was successfully treated by a team of doctors with bone marrow transplant (BMT).
She was diagnosed with MS, an autoimmune disorder where the body's immune system starts attacking the protective sheet covering the nerve cells in the brain and the spinal cord.
Juneja went through several rounds of treatments but could not be cured. She got another chance at life at Fortis Healthcare where the doctors treated her with BMT.
Dr Rahul Bhargava, Director, Clinical Hematology and Bone Marrow Transplant, Fortis Memorial Research Institute (FMRI) explained, "In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved. Chemotherapy is then administered to reset the body's immunity and then the stem cells are injected back to rescue the person from the side effects of chemotherapy. After the surgery, the patient is kept under isolation for a few months to ensure he/she does not contract any infection."
Since conventional steroid injections and immune therapy are expensive and don't promise a cure, Bhargava thought of going for a BMT for Juneja.
Juneja is now actively involved in raising awareness about MS amongst the community through social media.
Juneja said, "I had just completed my college education when I was diagnosed with multiple sclerosis. I was lucky because I got diagnosed within a week of my symptoms and could avail treatment options faster."
Dr Simmardeep Singh Gill, Zonal Director, FMRI added, "In this case, we have proved that bone marrow transplant can be seen as a successful alternate treatment option for multiple sclerosis patients, giving them a fresh shot at life".
Currently, there are 2.3 million people living with multiple sclerosis worldwide.
(With IANS inputs)
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Cellogica Launches Their Updated and More User-Friendly Website, Cellogica.com – Yahoo Finance
The New Cellogica Website Features In-Depth Information about the Skin Care Product, which Includes Stem Cell Technology
LOS ANGELES, CA / ACCESSWIRE / April 20, 2017 / The founders of Cellogica, a top line of skincare products that utilize stem cells and other innovative ingredients, are pleased to announce the re-launch of their website, Cellogica.com.
To check out the recently revised website, which is now easier than ever to navigate and features updated information about Cellogica, please visit http://www.cellogica.com at any time.
As a company spokesperson noted, Cellogica's "Two Secrets of Youth" involve the use of stem cell technology and also its MAC-5 Complex, which includes five ingredients that may help the skin look as young as possible. Rather than merely repairing the skin, Cellogica may actually help stop the loss of existing skin stem cells, as well as prevent premature aging.
Cellogica features a day cream, a non-greasy and light product which is designed to protect and enhance the skin and provide it with a natural barrier to the damaging UV rays of the sun and harsh weather. It also includes a night cream that works as the user sleeps by naturally repairing, restoring and regenerating the skin.
As the spokesperson noted, because skin stem cells are responsible for regenerating new and healthy skin cells, the founders of Cellogica were inspired to create a skin care cream that contains stem cells.
"Our revolutionary Stem Cell Technology is derived from strains of rare Swiss apples (Malus Domestica) and the Alpine Rose (Rhododentron Ferrugineum)," the spokesperson said, adding that together, these two very powerful stem cell extracts may allow for the regeneration of new skin stem cells, prevent the loss of existing skin stem cells, and increase the skin's barrier function.
"They may protect and repair the skin and combat against chronological aging, thus leading to fresh, healthy and vibrant looking skin."
The MAC-5 Complex is the other key component to Cellogica's ability to help improve the appearance of the skin. The proprietary combination includes Syn-Coll, which is an aqueous unpreserved glycerin-based solution that was developed to reduce wrinkles, as well as stimulate collagen synthesis. The other four ingredients in the MAC-5 Complex are RonaFlair LDP, hyaluronic acid, Syn-Ake, and Kojic acid, which may help eliminate blotchy skin while evening out the skin tone.
About Cellogica:
Cellogica is a premiere skincare line utilizing newly discovered stem cells to stop and reverse the physical signs of aging. To learn more about the product, please visit their website, http://www.cellogica.com.
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Plasticell And Kings College London To Collaborate In Trials Of … – Clinical Leader
Plasticell, a developer of cell therapies including hematopoietic cell replacement therapies, recently announced it has partnered with Kings College London to progress preclinical trials of its artificial blood platelet product, manufactured from pluripotent stem cells. The work is supported by a MedCity research grant which funds collaboration between leading SMEs and academics from London universities.
Over 10 million units of platelets are transfused worldwide each year in one of the most common procedures in clinical medicine. However, platelets derived from human donors can transmit infections and trigger serious immune reactions that eventually render the therapy ineffective (a condition known as alloimmune refractoriness). In addition, since platelet donations require pathogen testing and cannot be frozen for later use, supply shortages can occur under certain circumstances.
Plasticell has developed robust, cost-effective methods of producing functional platelets from human induced pluripotent stem cells (iPSCs) and has scaled these up to intermediate bioreactor level, allowing manufacture of product for pre-clinical studies. Kings College will contribute world-leading expertise and in vivo models to characterise the dynamics, lifespan, safety and efficacy of transfused platelets.
In addition to providing a more stable and safe supply of universal platelets, the use of iPS cells would allow us to create immunologically compatible matched platelets for patients suffering from alloimmune refractoriness, commented Dr Marina Tarunina, Principal Scientist leading the project at Plasticell.
The project is part of Plasticells hematopoietic cell therapy portfolio, which includes the expansion of umbilical cord- and bone- derived hematopoietic stem cells, and the manufacture of various blood cell types. Plasticell recently announced it had received Innovate UK funding for a 1.1M project to manufacture red blood cells from pluripotent stem cells, in collaboration with the University of Edinburgh.
About Plasticell Plasticell is a biotechnology company leading the use of high throughput technologies to develop stem cell therapies. The Companys therapeutic focus is in hematopoietic stem cell therapy, anaemia and thrombocytopenia, cancer immunotherapy and diabetes/obesity. Plasticells Combinatorial Cell Culture (CombiCult) platform technology, allows it to test very large numbers of cell culture variables in combinations to discover optimal laboratory protocols for the manipulation of stem cells and other cell cultures and has received a number of industry awards including the Queens Award for Enterprise in Innovation and the R&D 100 Award. For more information, visit http://www.plasticell.co.uk.
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Cellular Dynamics International Signs Collaboration Agreement with Harvard Stem Cell Institute – Business Wire (press release)
MADISON, Wis.--(BUSINESS WIRE)--Cellular Dynamics International (CDI), a FUJIFILM company and a leading developer and manufacturer of induced pluripotent stem cells (iPS), today announced it has signed a collaboration agreement with the Harvard Stem Cell Institute (HSCI), a novel network of stem cell scientists that extends from the University to its affiliated hospitals and the biomedical industry. The objective of the new partnership is to increase the availability of iPS cells and services to the HSCI network and the research community at large.
CDI is honored and excited to partner with Harvard Stem Cell Institute, one of the worlds most prestigious research organizations, said Dr. Bruce Novich, Division President-CNBD for FUJIFILM Holdings America Corporation and Executive Vice President and General Manager of Life Science Business Division for CDI. Our goal is to make iPS cells and technology more accessible so that researchers across disciplines and the various institutions of HSCI can better pursue the promise of stem cell science and regenerative medicine.
Under the terms of the agreement, CDI will collaborate with HSCIs iPS Core Facility by providing iPSC technology support to the stem cell community. In addition, CDI will offer critical iPSC technology elements which may accelerate iPSC based science, technology and applications.
About Cellular Dynamics International:
Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and supplier of human cells used in drug discovery, toxicity testing, and regenerative medicine applications. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, CDI is committed to advancing life science research and transforming the therapeutic development process in order to fundamentally improve human health. The companys inventoried iCell products and donor-specific MyCell Products are available in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. For more information please visitwww.cellulardynamics.com.
About Fujifilm
FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. In the year ended March 31, 2016, the company had global revenues of $22.1 billion, at an exchange rate of 112.54 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit:www.fujifilmholdings.com.
All product and company names herein may be trademarks of their registered owners.
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Clinical trial results show benefit of brain cancer therapy – Baylor College of Medicine News (press release)
Dr. Nabil Ahmed and Dr. Stephen Gottschalk discuss their investigation of a new treatment option for glioblastoma, the most common brain tumor in humans.
Glioblastoma is the most common brain tumor in humans and also one of the most difficult cancers to treat; patients with this type of cancer only survive about one year from time of diagnosis. Researchers at Baylor College of Medicine, Texas Childrens Cancer Center, and the Center for Cell and Gene Therapy at Baylor, Texas Childrens Hospital and Houston Methodist are investigating a new treatment option using modified T cells with anti-tumor properties with the goal of improving outcomes for patients with glioblastoma.
Their research focuses on engineered T cells that target the protein HER 2 expressed in low levels in glioblastoma cells. Results of a Phase 1 study published in the current issue of JAMA Oncology established the safety of these HER 2-specific, chimeric antigen receptor modified T cells (CAR T cells) when infused in to patients in increasing doses and, importantly, results also showed a clinical benefit to patients.
Our inability to effectively treat glioblastoma has been one of the failures of oncology, said Dr. Nabil Ahmed, associate professor of pediatrics at Baylor, Texas Childrens Cancer Center and the Center for Cell and Gene Therapy and first author of the paper. Glioblastoma is resistant to standard therapy, and it is difficult to remove all of the tumor cells through surgery without damaging the brain, so there is an urgent need for new and better treatment. Our work has focused on immune therapy, because it is very targeted and uses tumor-killing mechanisms that the cancers have not shown resistance to in the lab.
CAR T cells are T cells a type of immune cells involved in the defense against tumors that have been programmed to recognize and kill tumor cells carrying one specific antigen, in this case HER2, on the surface of cancer cells through an artificial molecule, the CAR, expressed on their surface.
The study included 17 pediatric and adult patients with HER 2-positive glioblastoma who received up to five escalating doses of the engineered T cells through intravenous infusions. Establishing the safety of the treatment is important, as other immunotherapy treatment approaches for solid tumors have resulted in significant side effects and toxicities for patients, Ahmed said.
First and foremost, the cells were safe. We did not see any life threatening side effects. Along with this we also saw measurable tumor responses, Ahmed said.
Median survival of patients who participated in the trial was 11.1 months post T cell infusion and 24.5 months from diagnosis. Three patients in the trial experienced no disease progression after more than two years of follow up.
With their promising results, Ahmed and his research colleagues, including Dr. Stephen Gottschalk, professor of pediatrics at Baylor, Texas Childrens Cancer Center and the Center for Cell and Gene Therapy and senior author of the paper, turn their focus to the next steps in the research.
In this phase 1 clinical trial we tested a particular modification that renders these cells specific for HER 2 and while the results have been encouraging, we are very interested to further engineer these cells, for example by making the T cells more effective after the infusion and by targeting not only HER2 but other molecules that are expressed on the cell surface of brain tumors, Gottschalk said.
The CAR T cells are produced in the cell manufacturing facility of the Center for Cell and Gene Therapy. Baylor is one of the few academic institutions that has such a facility, Gottschalk noted.
Others who contributed to this study include Vita Brawley, Meenakshi Hegde, Kevin Bielamowicz, Mamta Kalra, Daniel Landi, Catherine, Robertson, Tara Gray, Oumar Diouf, Amanda Wakefield, Alexia Ghazi, Claudia Gerken, Zhongzhen Yi, Aidin Ashoori, Meng-Fen Wu, Hao Liu, Cliona Rooney, Gianpietro Dotti, Andrea Gee, Jack Su, Yvonne Kew, David Baskin, Yi Jonathan Zhang, Pamela New, Bambi riley, Milica Stojakovic, John Hicks, Suzanne Powell, Malcolm Brenner, Helen Heslop, Roberta Grossman, and Winifred Wels, representing Baylor College of Medicine, Texas Childrens Hospital, Houston Methodist Hospital, and the Institute for Tumor Biology and Experimental Therapy in Frankfurt, Germany.
The study received funding from the Alliance for Cancer Gene Therapy, Cancer Prevention and Research Institute of Texas (RP110553), Alexs Lemonade Stand Pediatric Cancer Foundation, Stand Up to Cancer/St. Baldricks Pediatric Dream Team Translational Research Grant (SU2C-AACR-DT1113), the Clinical Research Center at Texas Childrens Hospital, the Dan L Duncan Institute for Clinical and Translational Research at Baylor, and by shared resources through Dan L Duncan Comprehensive Cancer Center Support Grant from the National Cancer Institute (P30CA125123).
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Clinical trial results show benefit of brain cancer therapy - Baylor College of Medicine News (press release)
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Inherited Retinal Disease Patients, Therapy Developers May Benefit From New Genetic Testing Program – GenomeWeb
NEW YORK (GenomeWeb) Genetic testing for inherited retinal diseases is often not covered routinely by health insurance, yet a molecular diagnosis is required for enrollment in a number of clinical trials for new gene- or mutation-specific treatments. To assess the benefit of genetic testing data and to enable more patients to take advantage of it, the Foundation Fighting Blindness has been conducting a pilot research program, providing gene panel testing to 100 members of its My Retina Tracker patient registry free of charge.
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Novartis drug development chief outlines CAR-T research commitment – FierceBiotech
Despite reports that linked Novartis to cutting back on its cell therapy work, the Swiss major said it is going full steam ahead for its CAR-T research as a potential approval for its candidate appears on the horizon.
In August of last year,Endpointsbroke the news thatthe Big Pharma was integratingits once standalone gene and cell therapy unit into the company. Most employees would beredeployed, but around 120 potentially face job losses.
This unit was doing work on the next new cancer class CAR-T, but some speculated that the disbanding of this unit meant that Novartis was looking to take a step back from research in this area.
Talk of its death was, however, greatly exaggerated according the the company. It saidits leading CAR-T candidate, CTL019 (tisagenlecleucel), now has two FDA breakthrough tags in two blood cancers, and was given a priority review for the med by the agency at the end of March.
The company is now in a race with biotech Kite Pharma to be the first to market this new type of cancer therapy that has shown some stellar results in clinical trials (although it also has revealedsome serious side effects from other companies, including Juno Therapeutics).
Speaking to FierceBiotech, Vas Narasimhan, M.D., global head of drug development and CMO at Novartis, said that there was a lot of interpretation last year regarding our reintegrating our cell and gene therapy unit into our R&D infrastructure, but was adamant that this did not create any difference in regards to our commitment in this space.
He said the integration of the unit into Novartis proper was primarily due to its success.
We had incubated the technology which came out of [its 2012 CAR-T deal] with Penn as a dedicated unit, and that was something that made sense: If you had immediately put that into the larger infrastructure of Novartis, it would have got lost, especially in the early stages when it was risky and it was unclear if this would be tractable," he said.
But Narasimhan said that as the unit became scaled, the parallel infrastructure scheme no longer made optimal sense.
To give this technology the best chance of succeeding, and in the most cost-effective way, we decided we should integrate [the unit] into our normal operations, and so CAR-T agents were then no different to an I-O agent, or anything else that we developed at Novartis, other than the fact that the process here is very important for the product," he said. We have the scale to work on these sorts of things quickly. So, the integration has allowed us to work on multiple programs in parallel, where I think the unit was focusing on just one or two programs at a time.
Now integrated, Narasimhan said its full steam ahead for CAR-T, and the immediate focus is to see through the two indications: r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients and r/r diffuse large B-cell lymphoma (DLBCL) for tisagenlecleucel this year, as well as a combined ALL and DLCBL submission in Europe in 2017.
On the R&D side, he sees a three-pillar approach for CAR-T. The first pillar is to continue to be innovative on the manufacturing side of things, which is a tricky and cutting-edge science in itself for CAR-T. We need to continue to invest to optimize our manufacturing platforms, bringing it to more patients as we expand indications, he says.
The second is to continue to work in blood cancers, where results for Novartis and others have been the strongest. He said that they have programs in CAR-T in combination with other meds, as well as research in multiple myeloma, with additional blood cancer programs also slated to run on its CAR-T platform.
And the third pillar, which could turn out to be the toughest for all involved, is the move into solid tumors.
We have a few different constructs now and were moving into the clinic, Narasimhan explains. Our most advanced CAR-T is targeting ovarian cancer as well as a few other solid tumors.
Solid tumor research in the industry using CAR-Ts has not to date, however, seen a translation from the strong data coming out of blood cancers, and a lot of uncertainty remains as to whether, and how, CAR-T can treat these types of cancer.
I asked Narasimhan how confident he and Novartis were in holding up its third pillar.
For solid tumors, we really need to wait for the clinical data to make a judgement and see how tractable it is. We know in the solid tumor microenvironment there is a lot more going on, and the question of course will be combination therapies and what kind of I-O combinations might be required to see deep and durable responses in solid tumors," he said."Its too soon to say what our confidence level is in solid tumors, other than to say that we have targets that we are interested in and weve built those constructs and are taking them into the clinic.
One of the big questions surrounding Novartis CAR-T program is the outcome of its JULIET trial for tisagenlecleucel, a study looking at the meds ability in DLCBL (where rival Kite is also working on). The data are in, but Novartis isnt sharing yet.
Our plan with JULIET is to announce it at an upcoming medical event, and once we get acceptance at a congress, well disclose it. We just want to ensure that we dont undermine our ability to present the data to a scientific congress.
But Narasimhan did say that the breakthrough designation it got this week from the FDA hopefully gives some indication, of how the data have panned out.
Lastly, we spoke about the FDA, which is under pressure from all directions as the new administration looks to cut back on regulations and direct funding (with a proposed increase in user fees), and internally, with some questioning whether it has at times lowered its standards to allow drugs through, such as those from Sarepta and more recently Marathon, and if this signals a sea change for the agency.
Narasimhan defended the FDA, saying it should be strong, but that it is under-resourced for what they have to do. If you look at 21st Century Cures Act and all the new things they have to do, the funding isnt necessarily all there yet for those new requirements.
He also saidthat the science and the technology being put up for review is getting more and more complex, and there is public pressure with right to try and patient group pressures as well on the FDA and these are only increasing, so they have to find the right balance."
I would say, in general, that the FDA does an extraordinary job having worked with them for many years, including on the H1N1 pandemic, and through various cycles of innovation. But, I think they need more time and money to invest in their people, so that they are up to speed on the latest science so that they can make measured decisions.
He said that despitethe agency's outlier cases,generally they continue to be very rigorous, in their reviews.
He also said it was incumbent on both the agency and the industry to do more to speed up R&D and approvals, and be open to new, but scientifically-led, approaches that can help get new drugs to patients more quickly.
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8-year-old patient surprises her bone marrow donor at their first … – The Straits Times
SINGAPORE - It was a bone marrow match that defied the odds of one in 20,000 - not once, but twice.
Just months after his first match fell through when the patient withdrew from treatment, Mr Phil Tan, 27, was again identified as a suitable bone marrow donor for another patient.
His donation saved the life of eight-year-old Ryssa, who was diagnosed with a rare blood disease called Myelodysplastic Syndrome about three years ago. Both met for the first time on Wednesday (April 19). Ryssa received the transplant just before her seventh birthday.
Mr Tan was one of 22 Singaporeans who were honoured by Minister for Home Affairs and Law K. Shanmugam for saving the life of a patient through the donation of their bone marrow.
"We celebrate those who have come forward without expecting a benefit, other than making a huge difference in someone else's life. It is the real spirit of giving," said Mr Shanmugam, who is a patron of the Bone Marrow Donor Programme (BMDP).
Bone marrow or blood stem cell transplant is the best treatment option for patients diagnosed with blood diseases such as leukaemia and lymphoma.
At any one time, there are at least 50 patients waiting to find a matching donor.
Siblings of the patient are the first options for a donation, as they have a one in four chance of DNA compatibility for a transplant.
When that fails, the next option would be a match with a volunteer donor registered in the BMDP.
To date, more than 75,000 volunteers have joined the BMDP register, which records the genetic type of each person.
Since 2015, more than 50 Singaporeans have donated their bone marrow to patients in Singapore and overseas, including in the United States, Britain, Canada and France.
The BMDP, which was set up in 1993, aims to increase the size of the local donor register by another 50,000 by next year.
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Brain Organoid Created from Stem Cells | Technology Networks – Technology Networks
Technology Networks | Brain Organoid Created from Stem Cells | Technology Networks Technology Networks Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. |
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Identical twins; not-so-identical stem cells – ScienceBlog.com – ScienceBlog.com (blog)
Salk scientists and collaborators have shed light on a long-standing question about what leads to variation in stem cells by comparing induced pluripotent stem cells (iPSCs) derived from identical twins. Even iPSCs made from the cells of twins, they found, have important differences, suggesting that not all variation between iPSC lines is rooted in genetics, since the twins have identical genes.
Because they can differentiate into almost any cell type in the body, stem cells have the potential to be used to create healthy cells to treat a number of diseases. But stem cells come in two varieties: embryonic stem cells (ESCs), which are isolated from embryos, and iPSCs, which are created in the lab from adult cells that are reprogrammed using mixtures of signaling molecules and are a promising tool for understanding disease and developing new treatments.
Although iPSCs resemble ESCs in most ways, scientists have found that iPSCs often have variations in their epigenetics methyl marks on the DNA that dictate when genes are expressed. These epigenetic markers arent the same between iPSCs and ESCs, or even between different lines of iPSCs. In the past, its been hard to determine what drives these differences.
When we reprogram cells, we see small differences when we compare them to stem cells that come from an embryo. We wanted to understand what types of differences are always there, what is causing them, and what they mean, says Juan Carlos Izpisua Belmonte, a professor in Salks Gene Expression Laboratory and co-senior author, with Kelly Frazer of the University of California, San Diego, on the new paper, which was published in Cell Stem Cell in April 2017. A better understanding of these differences will help researchers refine stem-cell based treatments for disease.
Izpisua Belmonte and Frazer, along with co-first authors of the paper Athanasia Panopoulos, formerly a postdoctoral fellow at Salk and now at the University of Notre Dame, and Erin Smith of UCSD, turned to twins to help sort it out.
Although identical twins have the same genes as each other, their epigenomesthe collection of methyl marks studding their DNAare different by the time they reach adulthood due in part to environmental factors. Reprogramming the skin cells of adult identical twins to their embryonic state eliminated most of these differences, the researchers found when they studied cells from three sets of twins. However, there were still key epigenetic differences between twins in terms of how the iPSCs compared to ESCs.
When the team looked more in depth at the spots of the genome where this variation between methyl marks tended to show up in twins, they found that they often fell near binding sites for a regulatory protein called MYC.
In the past, researchers had found lots of sites with variations in methylation status, but it was hard to figure out which of those sites had variation due to genetics, says Panopoulos. Here, we could focus more specifically on the sites we know have nothing to do with genetics. That new focus, she says, is what allowed them to home in on the MYC binding sites.
The MYC proteinwhich is one of the molecules used to reprogram iPSCs from adult cellslikely plays a role in dictating which sites in the genome are randomly methylated during the reprogramming process, the researchers hypothesized.
The twins enabled us to ask questions we couldnt ask before, says Panopoulos. Youre able to see what happens when you reprogram cells with identical genomes but divergent epigenomes, and figure out what is happening because of genetics, and what is happening due to other mechanisms.
The findings help scientists better understand the processes involved in reprogramming cells and the differences between iPSCs and ESCs, which has implications on future studies aiming to understand the specific causes and consequences of these changes, and the way iPSCs are being used for research and therapeutics.
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Identical twins; not-so-identical stem cells - ScienceBlog.com - ScienceBlog.com (blog)
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Cellular Dynamics International Signs Distribution Deal with STEMCELL Technologies – Yahoo Finance
MADISON, Wis.--(BUSINESS WIRE)--
Cellular Dynamics International (CDI), a FUJIFILM company and a leading developer and manufacturer of induced pluripotent stem cell-derived products, today announced it has signed a distribution agreement with STEMCELL Technologies, a world leader in iPS cell culture media.
This joint agreement with STEMCELL Technologies will make iPSC technology widely available to researchers worldwide, helping advance biological research leading to cellular therapies and drug discovery, said Dr. Bruce Novich, Division President-CNBD for FUJIFILM Holdings America Corporation and Executive Vice President and General Manager for CDI. We believe that STEMCELL Technologies, a leading developer, manufacturer and seller of stem cell related products, is an ideal partner for CDI, because their global sales and distribution infrastructure delivers to an established and an emerging customer base, which translates into faster access to and deeper penetration of CDIs leading edge technologies and products.
Under the terms of the agreement, STEMCELL Technologies will distribute CDIs iCell catalog of products in North America, Europe, and Singapore, with other countries under consideration. CDIs iCell products are differentiated human induced pluripotent stem cell (iPSC)-derived cells, which include cardiomyocytes, hepatocytes, and others, totaling up to 12 cell types.
STEMCELL Technologies is delighted for the opportunity to bring CDIs innovative products to the global research community. STEMCELL and CDI will work together on progressive solutions for the life science tools market. We look forward to a long and productive partnership with the shared goal of improving human health, said Dr. Allen Eaves, President and CEO of STEMCELL Technologies.
About Cellular Dynamics International:
Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and supplier of human cells used in drug discovery, toxicity testing, and regenerative medicine applications. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, CDI is committed to advancing life science research and transforming the therapeutic development process in order to fundamentally improve human health. The companys inventoried iCell products and donor-specific MyCell Products are available in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. For more information please visit http://www.cellulardynamics.com.
About Fujifilm
FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. In the year ended March 31, 2016, the company had global revenues of $22.1 billion, at an exchange rate of 112.54 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: http://www.fujifilmholdings.com.
About STEMCELL Technologies:
As Scientists Helping Scientists, STEMCELL Technologies is committed to providing high-quality cell culture media, cell isolation products, accessory tools and educational services for life science research. Driven by science and a passion for quality, STEMCELL provides over 2500 products to more than 90 countries worldwide. To learn more, visit http://www.stemcell.com.
All product and company names herein may be trademarks of their registered owners.
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Cellular Dynamics International Signs Distribution Deal with STEMCELL Technologies - Yahoo Finance
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Gene therapy for nervous system disorders – The Hippocratic Post – The Hippocratic Post (blog)
My decision to get involved with developing gene therapy for neurological disorders came about because my own daughter, Ornella, 11, was born with a rare genetic condition known as Sanfilippo Syndrome, or mucopolysaccharidosis (MPS-IIIA). One in 70,000 babies is born with this life-limiting condition that results from a genetic mutation of a particular enzyme and leads to toxic build-up of heparan sulphate in brain tissue. Heparan sulphate is necessary for the normal function of the brain, but too much can damage tissue.
Heparan sulphate is necessary for the normal function of the brain, but too much can damage tissue.
At present, there is no cure, treatment is palliative and sufferers die in their early teens. Symptoms range from mild developmental delay and hyperactivity, which leads to sleep disturbance to more profound problems, such as paralysis, usually before the child reaches his or her 10th birthday.
Five years ago, Ornella became the first person in the world to have an experimental new drug treatment that we are developing at Lysogene, the biotech company I founded with Olivier Danos, a leading researcher into neurodegenerative disease. He had already been looking into this area of research and was keen to look at novel approaches.
She was part of a Phase 1/2 clinical trial that took place in 2011 and 2012 to gauge the safety of gene therapy using an adeno-associated viral vector known as AAVrH10 to deliver a genetically modified N-sulfoglucosamine sulfohydrolase enzyme directly into the brain cells. This enzyme effectively mops up the excess heparan sulphate and disposes of it. Animal studies had already shown it was safe and effective. The four children involved ranged in age from just under 3 years old to just under seven years old and they were dosed individually, one after the other, over three month intervals. The vector is injected into areas of the brain that show signs of damage during an operation under general anesthesia
AAVrH10 is a viral vector that is able to move into brain cells more efficiently where it delivers the drug. Other AAV vectors have been investigated by other research teams but with less effective uptake of gene therapy in the brain. All AAV vectors are very safe and stable so they are long-lasting. They also seem to cause no harmful effects in brain tissue.
All AAC vectors are very safe and stable so they are long-lasting.
This is a very elegant solution to a problem that is very localised in MPS-IIIA patients. The vector delivers the drug directly to the neurons where it is needed. It is also a once-only therapy because it fixes the faulty DNA of the enzyme permanently. Sadly, many children with genetic diseases need to have regular therapy, which often requires a hospital visit several times a month. This kind of gene therapy should mean that there is no need to repeat it more than once.
Im glad to say that the trial, which only included human patients with advanced disease, was a success and the results were published in Human Gene Therapy in 2014. As well as being safe, the therapy resulted in reduction in symptoms and a big increase in quality of life. Ornella showed tremendous improvement and started sleeping through the night something that had never happened from the day she was born until she was treated at six years old. We are hopeful that the therapy may also have the ability to extend life for patients with this disease. Certainly, this is what we observed in early animal studies. Potentially, it may even be curative.
Without such promising results, there was no way that I could consider continuing with the research programme. If I had not been convinced of its efficacy and safety, I would have called a halt after the initial trials.
We are now preparing to embark on a larger scale Phase 3 clinical trial with 20 patients in all. This will take place in 2018. If all goes well, we hope to market the drug to patients by 2020. I feel really blessed and proud to be involved in such an important project and to part of such a great team at Lysogene.
Karen Aiach is speaking at the RSM Medical Innovations summit on April 22nd. http://www.rsm.ac.uk
Karen Aiach is CEO and founder of Lysogene, a biotech company developing gene therapy for central nervous system disorders.
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Team characterizes the underlying cause of a form of macular degeneration – Medical Xpress
April 19, 2017 by Katherine Unger Baillie The Penn-led research team characterized the underlying mechanism that leads to the blinding Best disease; a loss of the microvilli that support and "feed" photoreceptor cells. The contrast can be seen above, with a normal retina on the right and an affected on on the left. Credit: University of Pennsylvania
Named for Friedrich Best, who characterized the disease in 1905, Best disease, also known as vitelliform macular dystrophy, affects children and young adults and can cause severe declines in central vision as patients age. The disease is one in a group of conditions known as bestrophinopathies, all linked to mutations in the BEST1 gene. This gene is expressed in the retinal pigment epithelium, or RPE, a layer of cells that undergirds and nourishes photoreceptor cells, the rods and cones responsible for vision.
Despite the century of work on bestrophinopathies and the identification of genetic mutations responsible for the conditions, no one had identified the underlying mechanism that led to the vision loss seen in Best disease until now.
Using an animal model of Best disease in combination with biochemical and optical assays, a team of researchers at the University of Pennsylvania has pinpointed a number of abnormalities that give rise to the impairments seen in the disease.
"The genetic cause of the disease has been known for 20 years, but no one had samples of patients at the stage when the disease starts," said Karina E. Guziewicz, research assistant professor of ophthalmology in Penn's School of Veterinary Medicine and lead author on the study. But "we were now able to pinpoint this early stage and find out what factors trigger the development of lesions."
The new information sets the team up for testing a gene therapy to treat the disease, as the researchers will be able to observe whether or not these structural and biochemical abnormalities have been corrected.
"Now that we understand what we're seeing, it allows us to judge the success of a particular therapy," said Gustavo D. Aguirre, professor of medical genetics and ophthalmology at Penn Vet.
Kathleen Boesze-Battaglia, a professor in the Department of Biochemistry in Penn's School of Dental Medicine, also contributed her expertise in lipid biochemistry and spectral analysis of lipid debris to the study, which was published in the journal Progress in Retinal and Eye Research, the top ranked journal in the eye-research field.
"Interestingly, the lipid debris accumulation is similar to cholesterol rich plaque formation, compounded by a complexity of vitamin A metabolism," said Boesze-Battaglia. "Alterations in lipid metabolism likely contribute to the secondary disease pathology in this model."
The main puzzle surrounding Best disease was why, despite the BEST1 gene being mutated in the RPE throughout the retina, vision loss struck the macula and fovea, the central areas of the retina responsible for reading and tasks requiring high-resolution vision, while seeming to spare the rest. Researchers had observed lesions in this area, but it was unknown why they developed.
In this study, the Penn-led team discovered that this predilection of the macula to develop lesions has to do with differences in the supporting structures of rods versus cones.
Rods, which make up more than 90 percent of photoreceptor cells in the retina and are responsible for dim-light vision, have a cluster of supporting structures known as RPE microvilli that cup the cell like stakes holding up a plant. In contrast, cones, the color-sensing photoreceptors that make up 3 to 5 percent of all photoreceptors but are overrepresented in the macula, are engulfed in a sheath of microvilli. In addition, cones are supported by an insoluble matrix.
Examining cross-sections of the fovea-like region in the canine macula of dogs affected with the canine equivalent of Best disease, the researchers found that the microvilli don't form and that the matrix is fragmented. The susceptibility of the macula is due to the fact that cones are the predominant cell type there and rely on the matrix for support and nutrient exchange.
"We were not expecting to find such dramatic structural abnormalities," Guziewicz said. "For a hundred years, this has been thought to be a disease of the RPE, but we have now identified this as a disease of the RPE-photoreceptor interface."
"The RPE provides transport of nutrients to the cones and engulfs the discarded part of cones and rods," said Aguirre. "When you lose the matrix, you lose the connection between those cells and the RPE and that leads to disease."
To determine if the same would be true in humans, the researchers looked at human induced pluripotent stem cell-derived RPE from Best disease patients and found similar signatures: microvilli numbers were decreased in length and density. These experiments were conducted in collaboration with David Gamm's laboratory from the McPherson Eye Research Institute at the University of Wisconsin-Madison.
Looking ahead, the research team would like to continue to probe the biochemical signals that lead to the improper development of the microvilli and matrix and push ahead with developing and testing a gene-therapy approach to treating bestrophinopathies.
"Knowing where the disruptions occur will allow us to develop proper outcome measures for a gene therapy, which is in the works," said Guziewicz.
Explore further: Fighting blindness: Scientists bring a key protein into focus
More information: Karina E. Guziewicz et al, Bestrophinopathy: An RPE-photoreceptor interface disease, Progress in Retinal and Eye Research (2017). DOI: 10.1016/j.preteyeres.2017.01.005
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Outsourced Ion Channel Testing Trends – Technology Networks
Introduction
Ion channels play a key role in regulating electrical activity in excitable cells, and many additional roles in non-excitable tissues. They are important therapeutic targets in a range of indications including arrhythmia, hypertension, local anaesthesia, pain, stroke, epilepsy, depression, bipolar disorder, COPD, autoimmune disorders and diabetes. Not only are ion channels major drug targets, but they are also important indicators for drug safety. Indeed, many drugs withdrawn from the market due to cardiac related adverse effects have been shown to block the human ether-a-go-go (hERG) ion channel, which delays repolarization of the cardiac action potential and can result in a potentially fatal arrhythmia known as Torsades de Pointes (TdP).
Performing high throughput screening (HTS) or lead optimization against a target of interest, identification of a compounds target specificity by selectivity profiling, and checking for safety liabilities/risk assessment are all critical steps in the drug discovery process. Ion channel testing has evolved considerably in recent years with third generation automated patch clamping (APC) platforms addressing both voltage and ligand-gated channels at high throughput (HT) and at higher seal resistances. These newer HT APC platforms have allowed fee-for-service providers the possibility to offer cost-effective high quality outsourced ion channel primary screening and selectivity profiling for drug discovery, this is in addition to fluorescent-based assays and lower throughput conventional (manual patch) electrophysiology.
Read:automated patch-clamping trends
Most service providers that offer selectivity profiling have a large collection of stably transfected ion channel cell lines from which they assemble channel panels. Many service providers have also adapted and validated these cell lines for use on HT APC systems, some also sell their cell lines commercially. Providers of outsourced ion channel testing fall into 2 categories: 1) specialty CROs (i.e. providers with offerings limited to ion channel screening or ADME or animal models or clinical studies or any combination of these activities, but NOT the entire value chain); and 2) single-source or integrated CRO (i.e. a one-stop shop offering all activities).
In July 2016, HTStec undertook a market survey on outsourced ion channel testing mainly among research labs in pharma, biotech and academia. The survey was initiated by HTStec as part of its tracking of life science marketplaces and to update their previous outsourced ion channel testing trends report (published May 2013). The main objectives were to comprehensively document current use of and potential interest in outsourcing ion channel primary screening, selectivity profiling and safety liability testing. The survey also investigated access to stably transfected cell lines and future purchasing plans. The aim was to compile a reference document on outsourced ion channel testing, which could be directly compared with HTStecs previous 2013 report. This article contains selected findings from the HTStec market report, Outsourced Ion Channel Testing Trends 2016.
It is intended to provide the reader with a brief insight into recent market trends. It covers only 11 out of the 32 original questions detailed in the full report. The full published report should be consulted to view the entire dataset, details of the breakdown of the responses for each question, its segmentation and the estimates for the future.
Outsourced primary screening of ion channels Only a minority (32%) of survey respondents have outsourced the primary screening of ion channels to date and 18% of survey respondents had no foreseeable interest in outsourcing primary screening over the coming years. Where interested, the platforms for the primary screening of ion channels survey respondents most want to outsource to fee-for-service providers are given in Figure 1. This showed that automated patch-clamp (APC) was the most wanted platform (46%). This was followed by fluorescence-based assays (e.g. FLIPR/Hamamatsu FDSS) (19%), manual patch clamp (16%), multi-electrode array assays (MEA) (12%), and then membrane binding assays (6%). In contrast, the most used platform for primary screening of ion channels undertaken in- house is fluorescence-based assays.
Figure 1. Ion Channel Primary Screening Platform Respondents Want To Outsource At A Fee-For-Service Provider. Outsourced selectivity profiling of ion channelsMost (61%) survey respondents outsourced selectivity profiling of ion channels in 2016 and only a minority (9%) of survey respondents do not anticipate outsourcing over the coming years. The platforms for selectivity profiling of ion channels survey respondents most want to outsource to fee-for-service providers are presented in Figure 2. This showed that the preferred platform for selectivity profiling of ion channels to be accessed at service providers was automated patch-clamp (APC) (47%). This was followed by: manual patch clamp (28%); fluorescence-based assays (e.g. FLIPR/Hamamatsu FDSS) (11%); multi-electrode array assays (MEA) (8%); and membrane binding assays (6%).
Figure 2. Ion Channel Selectivity Profiling Platform Respondents Want To Use/Access At A Fee-For-Service Provider.
The stage in the drug discovery process where survey respondents most want outsourced selectivity profiling is shown in Figure 3. This showed that most (24%) respondents want to outsource selectivity profiling after hits-to-leads (lead optimization). This was followed by either: after secondary/counter screening or after primary screening/HTS (both 15%); after some initial selectivity profiling results generated in- house (14%); no fixed stage, we want to profile lead compounds from other therapeutic areas (12%); and then, when about to start IND enabling (3%).
Figure 3. When Respondent's Want To Outsource Selectivity Profiling.
The preferred way of selecting particular assays for outsourced ion channel selectivity profiling are given in Figure 4. This showed that respondents ranked selection by target as their most preferred way of choosing assays when deciding on ion channel selectivity profiling. This was followed by selection by family, selection by testing platform, and then selection by therapeutic area.
Figure 4. Preferred Way Of Selecting Assays For Ion Channel Selectivity Profiling.
The ion channel panels of most interest when considering outsourced selectivity profiling are presented in Figure 5. This showed that a cardiac channel panel was most wanted for selectivity profiling (26%). This was followed by a cardiovascular channel panel (16%), and then a pain-inflammation channel panel (13%). All others panel had less than 10% interest.
Figure 6. What Motivates Selection Of An Ion Channel Selectivity Profiling Provider.
Outsourced ion channel safety liability testing The aspect of ion channel safety liability testing survey respondents most want to outsource today are given in Figure 7. This showed that cardiac ion channel panel assays - automated patch clamp; hERG IC50 assay - non-GLP; and hERG ion channel assays were the most wanted assays (all with 41%). They were followed by hERG IC50 assay GLP (30%); and then cardiac ion channel panel assays - manual patch clamp and hERG screening assay (both 25%). Least wanted were stem cell-derived human cardiomyocytes assays (field potential, MEA, impedance, IcaICa, L activator assay).
Figure 7. Aspects Of Ion Channel Safety Liability Testing Outsourced. What motivates end-user selection of an ion channel safety liability provider is reported in Figure 8. This showed that cutting-edge gold standard assays were ranked as what most motivates their selection of an ion channel safety liability provider. This is very closely followed by comprehensive nature of the tests and assays offered, and then expertise in predicting cardiac risk and price. Ranked as least influential was Involvement in comprehensive in vitro proarrhythmia (CiPA) working groups.
Figure 8. What Motivates Selection Of An Ion Channel Safety Liability Provider. Spending on ion channel testing servicesHow survey respondents spend on outsourced ion channel testing services is broken down and presented in Figure 9. This showed that the biggest proportion (29%) of survey respondents 2016 outsourced ion channel testing budget was spent on selectivity profiling, this was followed by primary screening (25%); GLP Safety liability testing against hERG (16%); other safety testing (12%); non-GLP Safety liability testing against hERG (11%); and then assays fulfilling CiPA recommendations (7%).
Figure 9. Breakdown Of Current (2016) Outsourced Ion Channel Testing Budget.
The most used fee-for-service providers of ion channel testing services are reported in Figure 10. This showed that Eurofins (33%) was the most used fee-for-service provider of ion channel testing. It was very closely followed by Charles River (30%) and then more distantly by Thermo Fisher Scientific (9%), Aviva Biosciences (4%), SB Drug Discover (4%)y and Wuxi Pharmatech (4%). All other providers (totaling 17%) each had less than 4% share of use. This provider selection should not be confused as a true market share, it is not based on the actual $ value of services purchased, but on which provider survey respondents indicated they have most used over the past 12 months.
Figure 10. Most Used Fee-For-Service Providers Of Ion Channel Testing Services.
The importance (influence on provider selection) of an ion channel testing fee-for-service provider offering specific services is detailed in Figure 11. This showed the survey respondents rated most highly access to selectivity profiling (ion channels only) as the offering an ion channel service provider must provide to be worthy of consideration. This was followed by selectivity profiling (ion channels, GPCRs & kinases); and then assays fulfilling CiPA recommendations and GLP safety liability testing. Rated least wanted (not needed) was med chem around lead series (Figure 10).
Figure 11. Importance Of An Ion Channel Testing Provider Offering The Following Services.
Overall the use of outsourced ion channels testing services, particularly for selectivity profiling, is the preferred option for many drug discovery groups. However, the implementation of the CiPA initiative is expected to change the focus in nonclinical cardiac safety assessment by replacing the early hERG assessment (non-GLP) with an evaluation of compounds against multiple cardiac currents (APC); in silico modeling of cardiac action potentials; and the use of stem cell-derived human cardiomyocyte assays (e.g. MEA), as a multicellular test system that recapitulates the physiological properties of the human heart (e.g. with ECG-like field potentials). CiPA does however not displace GLP hERG or GLP in vivo ECG in a large animal which will still be needed for IND enabling, and are key services available at CROs. It will be interesting to see how outsourced providers of in channel testing services adapt to the changing regulatory requirements and the emergence of new in vitro screening technologies and approaches over the coming years.
DISCLAIMER: HTStec Limited has exercised due care in compiling and preparing these Selected Findings from its Report, which is based on information submitted by individuals in respondent companies. HTStec Limited has NOT verified the accuracy of this information, nor has it established respondents authority to disclose information to HTStec Limited. HTStec Limited expressly disclaims any and all warranties concerning these Selected Findings including any warranties of merchantability and/or fitness for any particular purpose, and warranties of performance, and any warranty that might otherwise arise from course of dealing or usage of trade. No warranty is either expressed or implied with respect to the use of these Selected Findings. Under no circumstances shall HTStec Limited be liable for incidental, special, indirect, direct or consequential damages or loss of profits, interruption of business, or related expenses that may arise from the use of these Selected Findings, including but not limited to those resulting from inaccuracy of the data therein.
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Husaini trust plans to perform bone marrow transplants, stem cell therapy – The News International
The Husaini Haematology and Oncology Trust will soon provide facilities of bone marrow transplant and stem cell therapies at its newly established Blood Transfusion Centre and Thalassaemia Centre that was inaugurated by the city director health on Tuesday.
Speaking at the inaugural ceremony, Karachi director health Dr Muhammad Toufique urged the trust officials to share the data of patients undergoing blood transfusions, stem cell therapies and bone marrow transplant.
He said the data would help the Sindh government formulate a plan to establish more such facilities in the future. In addition to the blood screening and storage facilities, the centre is providing blood transfusion service to children suffering from genetic blood disorders as well as diagnostic services related to blood disorders.
This is a state-of-the-art blood transfusion and thalassaemia centre where bone marrow transplant and stem cell therapies would be started very soon, said a renowned haematologist associated with the Husaini Blood Bank, Dr Sarfraz Jaffery, at the inaugural ceremony of the blood transfusion and thalassaemia centre located at Qalandaria Chowk, North Nazimabad.
The head office of the Husaini Haematology and Oncology Trust is equipped with a diagnostic lab, blood bank having storage capacity of around 3,000 blood bags and blood transfusion centre for thalassaemic patients while its management is also planning to introduce bone marrow transplant and stem cell therapy services at the same facility in the near future.
Felicitating the trust officials, the city director health vowed to support them in their services. He said the government was also striving hard for provision of safe blood to thalassaemic children and other patients.
Dr Toufique hoped that institutions like Hussaini would come forward to support the government in establishing such centres in the province. Talking to journalists, the director health said steps were being taken to control the outbreak of Chikungunya in the city.
He said the health department was in contact with the municipal authorities to start fumigation in various areas of Karachi to eliminate the mosquitoes and prevent people from mosquito-borne diseases, including dengue and Malaria.
The Sindh government was planning to merge the Malaria and Dengue Prevention and Control Cells under one project director, who would be utilizing all the resources to eliminate the mosquitoes that were responsible for the deadly infectious diseases in the province, he added.
I would also urge people to take precautionary measures, prevent themselves and their children from mosquitoes by using repellents, improving sanitation conditions in their residential areas and adopt other preventive measures to protect themselves against the mosquitoes, he advised.
Earlier, speaking at a workshop on thalassaemia management held at the same place, noted haematologists of the country stressed the need for promoting the culture of prevention from diseases in the country.
They called for the implementation of laws regarding thalassaemia screening, saying that both the government and private sector could not treat the increasing number of thalassaemic patients.
Senior haematologist from Lahore, Prof Dr Jovaria Mannan, urged the doctors and researchers to use latest research methods in the field of haematology.
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