Stem Cell Clinic

Buy PRP Kits & Stem Cell Therapy Supplies for Regenerative …

By Stem Cell Doctors

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Apex Biologix understands the challenges of increased medical supply costs and a patients desire to receive quality care at an affordable cost. XCELL PRP was designed to deliver on those needs. No longer do you have to choose between a low-cost PRP system with low concentration numbers and an overpriced priced system.

Ease of Use

Using our patented processing accessories (lead screw, benchtop processing station) you can easily capture the buffy coat through a convenient push method. The buffy coat layer and easier-to-read markings on the kit allow a user to accurately obtain reproducible results consistently. Overall processing time is quicker, has fewer steps than most systems on the market, and fits into many centrifuge systems.

Kit Contents

2 - SYRINGE 60CC (LUER LOCK) 1 - NEEDLE 18G X 1" 1 - SYRINGE 12CC (LUER LOCK) 1 - Luer, 45 Degree Bent, Dispensing Tip 1 - APEX P60A Concentrating Device 1 - APEX P60A Cap 4 - ALCOHOL PREP PAD - NON-STERILE SOLUTION 5 - GAUZE SPONGE 4 X 4-8 PLY 2 - ADHESIVE BANDAGE 1 - LATEX FREE TOURNIQUET 1 - ABSORBENT TOWEL 2 - GLASSINE BAG 1 - HOSPITAL WRAP 1 - HEADER BAG 1 - MEDIUM POWDER-FREE SYNTHETIC GLOVE LATEX FREE 1 - YELLOW FACE MASK EARLOOPS 3 - UNIVERSAL MALE/FEMALE NON-VENTED CAP 1 - MALE LUER CAP 4 - WHITE BLANK LABEL

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Buy PRP Kits & Stem Cell Therapy Supplies for Regenerative ...

Stem Cell Therapy Atlanta Home – Southern Stem Cell Institute

By Stem Cell Medical Center

Dr. Ambrozic has been a physician for over 20 years, and during that time, he earned his medical degree from the University of Alberta and completed a residency in health prevention and family medicine at the University of British Columbia (both Universities Medical programs are among the best in the world). Dr. Ambrozic was the assistant team physician of the University of British Columbia Thunderbirds Football Team during that time. After moving to the United States, he was also the assistant emergency director for a couple of emergency rooms in South Georgia. Dr. Ambrozics journey in regenerative medicine began early while he was in medical school. He conducted research into wound healing and burns involving growth factors. He also completed a fellowship at the University of South Florida in anti-aging and esthetics, where he furthered his learning and training in regenerative medicine. Committed to excellence and lifelong learning, he is also a member of the Harvard Medical School Postgraduate Association.

He has worked with numerous world leaders in medical care and treated many athletes and celebrities. He founded Southern Stem Cell Institute with the mission to be Committed to Research and Using State of the Art Stem Cell and Regenerative Therapies in an Ethical and Safe Manner.

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Stem Cell Therapy Atlanta Home - Southern Stem Cell Institute

Tracing the origin of adult intestinal stem cells | Nature

By Adult Stem Cells

Clevers, H. The intestinal crypt, a prototype stem cell compartment. Cell 154, 274284 (2013).

Barker, N. et al. Identification of stem cells in small intestine and colon by marker gene Lgr5. Nature 449, 10031007 (2007).

Shyer, A. E., Huycke, T. R., Lee, C., Mahadevan, L. & Tabin, C. J. Bending gradients: how the intestinal stem cell gets its home. Cell 161, 569580 (2015).

Nigmatullina, L. et al. Id2 controls specification of Lgr5+ intestinal stem cell progenitors during gut development. EMBO J. 36, 869885 (2017).

Tetteh, P. W. et al. Replacement of lost Lgr5-positive stem cells through plasticity of their enterocyte-lineage daughters. Cell Stem Cell 18, 203213 (2016).

van Es, J. H. et al. Dll1+ secretory progenitor cells revert to stem cells upon crypt damage. Nat. Cell Biol. 14, 10991104 (2012).

Buczacki, S. J. et al. Intestinal label-retaining cells are secretory precursors expressing Lgr5. Nature 495, 6569 (2013).

Yui, S. et al. YAP/TAZ-dependent reprogramming of colonic epithelium links ECM remodeling to tissue regeneration. Cell Stem Cell 22, 3549 (2018).

Nusse, Y. M. et al. Parasitic helminths induce fetal-like reversion in the intestinal stem cell niche. Nature 559, 109113 (2018).

Guiu, J. & Jensen, K. B. From definitive endoderm to gut-a process of growth and maturation. Stem Cells Dev. 24, 19721983 (2015).

Sumigray, K. D., Terwilliger, M. & Lechler, T. Morphogenesis and compartmentalization of the intestinal crypt. Dev. Cell 45, 183197 (2018).

Mustata, R. C. et al. Identification of Lgr5-independent spheroid-generating progenitors of the mouse fetal intestinal epithelium. Cell Reports 5, 421432 (2013).

Moor, A. E. et al. Spatial reconstruction of single enterocytes uncovers broad zonation along the intestinal villus axis. Cell 175, 11561167 (2018).

Merlos-Suarez, A. et al. The intestinal stem cell signature identifies colorectal cancer stem cells and predicts disease relapse. Cell Stem Cell 8, 511524 (2011).

Shyer, A. E. et al. Villification: how the gut gets its villi. Science 342, 212218 (2013).

Walton, K. D. et al. Hedgehog-responsive mesenchymal clusters direct patterning and emergence of intestinal villi. Proc. Natl Acad. Sci. USA 109, 1581715822 (2012).

Itzkovitz, S., Blat, I. C., Jacks, T., Clevers, H. & van Oudenaarden, A. Optimality in the development of intestinal crypts. Cell 148, 608619 (2012).

Sato, T. et al. Single Lgr5 stem cells build cryptvillus structures in vitro without a mesenchymal niche. Nature 459, 262265 (2009).

Fordham, R. P. et al. Transplantation of expanded fetal intestinal progenitors contributes to colon regeneration after injury. Cell Stem Cell 13, 734744 (2013).

Yui, S. et al. Functional engraftment of colon epithelium expanded in vitro from a single adult Lgr5+ stem cell. Nat. Med. 18, 618623 (2012).

Ritsma, L. et al. Intestinal crypt homeostasis revealed at single-stem-cell level by in vivo live imaging. Nature 507, 362365 (2014).

Tian, H. et al. A reserve stem cell population in small intestine renders Lgr5-positive cells dispensable. Nature 478, 255259 (2011).

Chan, C. J., Heisenberg, C. P. & Hiiragi, T. Coordination of morphogenesis and cell-fate specification in development. Curr. Biol. 27, R1024R1035 (2017).

Hannan, N. R. et al. Generation of multipotent foregut stem cells from human pluripotent stem cells. Stem Cell Reports 1, 293306 (2013).

Spence, J. R. et al. Directed differentiation of human pluripotent stem cells into intestinal tissue in vitro. Nature 470, 105109 (2011).

Watson, C. L. et al. An in vivo model of human small intestine using pluripotent stem cells. Nat. Med. 20, 13101314 (2014).

Sun, X. et al. Directed differentiation of human embryonic stem cells into thymic epithelial progenitor-like cells reconstitutes the thymic microenvironment in vivo. Cell Stem Cell 13, 230236 (2013).

McCracken, K. W. et al. Modelling human development and disease in pluripotent stem-cell-derived gastric organoids. Nature 516, 400404 (2014).

Kroon, E. et al. Pancreatic endoderm derived from human embryonic stem cells generates glucose-responsive insulin-secreting cells in vivo. Nat. Biotechnol. 26, 443452 (2008).

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el Marjou, F. et al. Tissue-specific and inducible Cre-mediated recombination in the gut epithelium. Genesis 39, 186193 (2004).

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Tracing the origin of adult intestinal stem cells | Nature

4 Barriers To Cell And Gene Therapy Development For Rare …

By Gene Therapy Clinics

By Ben Solaski and Perry Yin, Ph.D., PA Consulting

Rare diseases, as defined by the Orphan Drug Act, are diseases that affect less than 200,000 people. Given that approximately 80 percent of the 7,000 known rare diseases are caused by a single-gene defect,1 there has been increased research in the development of cell and gene therapies to treat rare diseases.

However, a number of challenges hinder these efforts, including pricing and reimbursement, the high cost of bringing these drugs to market, unique manufacturing and supply chain challenges, and our current limited understanding of disease pathology and progression. While these challenges may seem common across other drug markets, in the case of rare diseases, these challenges are exacerbated by limited patient populations. In this article, we look at the four challenges in greater depth and explore potential responses to help pharma companies be successful in bringing these products to market.

1. Making Commercialization Viable By Tackling High Costs Together

Given the small patient population, and the high price of drugs aimed at rare diseases, how can we ensure the long-term commercial viability of these drugs? This challenge can be explored from two points of view - how health authorities can promote scientific advancements while also protecting investments in rare disease development and how pharma can collaborate with payers to find better pricing solutions to reduce hurdles for patients to receive treatment.

Over the years, the FDA has taken concrete steps to incentivize the industry to develop drugs for rare diseases. In 2017, the FDA sought to eliminate the backlog for orphan drug requests by responding to future requests within 90 days.2 More recently, the FDA released a Draft Guidance on Human Gene Therapy for Rare Diseases, which pledges that the FDA will be involved with drug companies earlier in the development process. This will not only help streamline development by helping limit the number of preclinical or other preparatory studies but will also lower development costs and increase speed to market.3 But is this enough? There is ongoing debate in the pharma industry that the FDA needs to go even further. For example, while the agency already grants a longer exclusivity period for orphan drugs, this seven-year period is usually outlasted by the 20-year protection offered by patents.4 To sweeten the deal, the FDA may need to consider offering increased protection by expanding this exclusivity period. This would make these drugs more commercially viable, better ensuring capture of initial and ongoing investment in small markets or providing an option for improved pricing scenarios.

On the payer front, as the healthcare industry shifts toward value-based healthcare, orphan drugs and cell and gene therapies that have been prohibitively expensive will be prime candidates for emerging pricing models derived from measuring health outcomes against the cost of treatment. One great example is Novartis CAR-T treatment, Kymriah. For this treatment, Novartis only receives payment if the patient shows significant improvement within a month; otherwise, Novartis bears the cost. The use of value-based pricing models for cell and gene therapies would ease the amount of risk that payers take on when reimbursing these treatments, while also increasing the likelihood that patients will have access to these drugs.

With higher rates of approvals, longer periods of exclusivity, and greater utilization of value-based pricing, cell and gene therapies for rare diseases will have a greater chance of both reaching patients and being commercially successful.

2. Improving Clinical Development: A New Age In Clinical Trial Design And Recruitment

Companies developing cell and gene therapies for rare diseases are confronted with many of the same challenges faced by more traditional drugs; however, these challenges are amplified. These challenges include small patient populations, high mortality rates, and lack of disease state understanding, making it difficult to set clinical endpoints.

Seeking to address this, the FDAs Draft Guidance on Human Gene Therapy for Rare Diseases focuses on new clinical trial designs. What will these trials of the future look like? Gone are the days of three-phase randomized, controlled clinical trials. New age trials for rare diseases will be shorter, combining phases to show both safety and efficacy. Later stage trials will be replaced with rollover studies to see longer-term effects of treatment. Control groups will be replaced with natural history studies to illustrate what happens when patient groups go untreated. Natural history studies will also help to identify surrogate endpoints that can serve as early indicators of future outcomes to help expedite trials.

While these trial designs will help improve the process, there is still the inherent issue of recruiting from such small and geographically diverse patient populations. To ease this, there will be increasing demand for accurate patient registries that include relevant information about potential biomarkers for treatment. GSKs partnership with 23andMe is a good example of how this would work. Genetic data is captured through commercial genetic testing, then used to drive novel drug development and identify patients with specific rare diseases for trial recruitment. Pharma and CROs will also leverage increased use of digital technology to execute remote or highly fragmented multisite trials, making trial participation easier for patients.

Streamlining the clinical trial pathways for gene therapy and rare diseases, as well as reducing the burden on the patient, allows pharma companies to accelerate products to market.

3. Overcoming The Challenges Of Manufacturing And Supply Chain By Partnering With Contract Manufacturer Organizations

There are two major manufacturing challenges. The first is addressing the need for new infrastructure such as advanced supply chains, since the effective handling of these treatments will often require a high degree of customization for the patient (e.g., CAR T cell therapies). The other challenge lies with rare disease and cell and gene therapy products, whose manufacturing requires specialized skills where there is little room for error. As such, organizations will need to decide if they will build the capability or leverage contract organizations.

To address these challenges, in the short term, it is essential that companies have robust chain of custody protocols and supporting technologies to track and monitor these drug products from factory to patient. This ensures the correct patient is getting the therapy that was specifically designed for them, and that the conditions in transit do not damage the drug product. Longer term, the rise of a larger number of small manufacturing sites spread across the country is expected. Smaller manufacturing sites distributed in key geographic regions reduce shipping time, thus reducing the possibility for delays. Taking this one step further, imagine a world where manufacturing sites do not exist, and hospitals or clinics will have the capability and infrastructure to perform specialized manufacturing on-site.

How can pharma get to a commercial scale to support successful complex manufacturing requiring specialized skills? One solution is to outsource manufacturing to contract manufacturing organizations (CMOs) that specialize in gene therapies and rare diseases, similar to the way that clinical research has increasingly relied on contract research organizations (CROs). CMOs manufacture the product as a service and use their expertise to produce high-quality product at a reduced cost.

By using specialists to support the manufacturing process and technology to monitor and localize the supply chain, companies can reduce the risks involved in getting high-quality products to patients.

4. Increasing Our Understanding Of Disease States: The Rise Of Natural History Studies And Companion Diagnostics

Currently, there is a lack of understanding of rare diseases, especially around diseases variations and subtypes. This creates the challenge of how to better identify these variations to develop treatments that are then targeted at a specific disease subtype.

Pharma companies will need to spend more time and effort understanding disease states. For rare diseases, natural history studies are critical to provide insight that could help to drive early development, and even serve as a control group in single-arm studies if randomized, concurrent controlled trials are not feasible.5 Natural history studies may also help identify biomarkers that will help tailor these cell and gene therapies to be more personalized to specific subgroups of patients, allowing companies to be more focused in the development process.

Furthermore, to get the best results from treatment, the patient population that would benefit most from treatment needs to be identified. Thus, the industry will likely see an increase in products entering the market that include a companion diagnostic. Both the FDA and payers have an incentive to require drug manufacturers to develop these diagnostics in parallel with drug projects to ensure the best patient outcomes possible. Advancements in next-generation sequencing techniques will make identifying these subgroups easier and more accurate, potentially leading to a one size fits all genetic test that could be applied to all rare disease products.

Genetic tests, combined with an increase in understanding of natural history and disease biomarkers, will ensure the correct patients are receiving the therapies being developed.

Conclusion

Cell and gene therapies for the rare disease space are still emerging and will continue to face new challenges around development, the evolving regulation landscape, pricing and reimbursement, and manufacturing. Despite these challenges, the first products have already reached the market. New approaches and solutions, such as some of those outlined in this article, will go a long way to meeting these challenges and reducing the barriers to entry, allowing pharma to bring these products to market more quickly and affordably.

References:

About The Authors:

Ben Solaski is a life sciences expert at PA Consulting. With his training as a biomedical engineer, he has extensive experience with the development of gene editing technologies and an understanding of their potential to disrupt the industry. Contact him on LinkedIn at https://www.linkedin.com/in/benjaminsolaski/.

Perry Yin, Ph.D., is a life sciences expert at PA Consulting, where he leads the Cell and Gene Therapy group. He has experience developing technologies like CRISPR and stem cell-based therapies from concept to animal testing for both cancer and regenerative medicine applications. Contact him on LinkedIn at https://www.linkedin.com/in/yinperry/.

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Dr. Bermans’s Stem Cell Therapy – Mark Berman MD

By Stem Cell Medical Center

Dr. Berman talks about his research in fat stem cells.

Most people (doctors included) believe that stem cell therapy is still several years away from being available to the public. However, since 2010, in association with my partner, urologist Elliot Lander, MD, FACS, we have been conducting stem cell deployment as part of an ongoing investigative project collecting data on thousands of treated patients. After several successful outcomes in the orthopedic arena that I obtained in collaboration with orthopedic surgeon, Dr. Tom Grogan, Elliot and I formed the California Stem Cell Treatment Center followed a year later by the Cell Surgical Network the worlds largest network of stem cell physicians utilizing technology we developed with renown Korean plastic surgeon, Dr. Lee Hee Young. We currently teach doctors from the USA and worldwide our techniques using the CSN Time Machine to effectively harvest and process fat into stromal vascular fraction (SVF) rich in stem cells. Starting with a 10 minute mini-liposuction painlessly done under local anesthesia, this 1 hour process has yielded results that have been successfully recapitulated all over the world. Currently, there are about 100 CSN centers in the US and many more throughout the world, including dozens in China in association with our partners, RE Stem Biotech.

We are now in a new era of medicine. Our bodies are made up of dozens of trillions of cells. Up until now, medicine was predominantly aimed at keeping our cells healthy and alive through diet, exercise, medications to eradicate disease, or supplements to help our cells stay healthy, but now, going forward, we have the opportunity to replace injured or dying cells with our own DNA coded stem cells. These cells can not cause an allergic response or be rejected. While many people consider this experimental, we really consider it investigational but not really experimental. This may be a NEW era in medicine, but it really reflects perhaps the OLDEST form of intervention. Before we had any kind of medical intervention we had to rely on our bodys natural cell defense to keep us healthy. We now have the ability to unlock and harvest huge quantities of these repair cells for immediate use and, further, we can send samples to our lab where they can be cryopreserved and expanded as millions of stem cells for later use. Indeed, we have coined the term CRT Cell Renewal Therapy to describe how we foresee the future of medicine whereby your natural spare parts in the form of your own DNA cultivated stem cells will be made available to keep your body healthy and extend longevity for years beyond anything ever imaginable.

Stem cells are basically unspecialized cells that can replicate and differentiate (i.e. turn into other specialized cells). They tend to have three basic properties: 1) anti-inflammatory; 2) immune-modulatory and 3) reparative or regenerative. Most people think an embryo is the most common source for stem cells. While most stem cell studies started by using embryos, there are a number of issues and problems associated with their use. Not only are there ethical concerns, embryonic stem cells can sometimes form tumors (i.e. teratomas).

There are also a lot of stem cells naturally found in our body. Most people are aware of bone marrow derived stem cells. In recent years, bone marrow has been a source for stem cells particularly for orthopedic conditions. However, stem cell yields in bone marrow tend to be between 50,000 and 200,000 with some of the newer technology. Adipose (fat) tissue also houses vast quantities of stem cells. In fact, just 30 ccs (2 tablespoons) of fat can yield between 10 and 30 million stem cells.

Our fat derived stem cells have a tremendous capacity to turn into a large variety of tissues. Originally, because of their mesenchymal origin we thought they could only turn into fat, cartilage, bone, muscle, connective tissue, blood vessels and nerve tissue, but now we have studies showing theyve turned into practically every kind of cell in the body. While the bone marrow proponents will sing the virtues of bone marrow stem cells for cartilage repair, it turns out that fat derived cells are an even greater source for cartilage repair and production. Compared to a bone marrow harvest, its so simple to harvest a little fat and the yields are generally very high making fat an ideal source for stem cells.

When we started our studies in 2010 the critics suggested it might not be safe. Our initial study made SAFETY the primary objective and the clinical outcomes a secondary objective. Our safety study of over 1500 patients has shown that there are no significant adverse events related to the deployment of SVF. Indeed, the only real issues have been some mild discomfort around the liposuction site something we naturally expect. Weve submitted this paper for publication.

While there are a growing number of doctors claiming to provide stem cell treatments, we believe the most ethical approach is to do it under the umbrella of IRB approved research protocols. An IRB is an Institutional Review Board or an organization of members responsible for approving and overseeing research on humans. IRBs are approved under the auspices of the U.S. Department of Human Research Protection. As such, our patients understand the investigational nature of our activities, are provided appropriate informed consents, and are followed continuously on an online database to chart their progress or any issues of concern. This will allow us to not only accumulate safety data but demonstrate effectiveness of treatments and help us to improve treatment programs going forward.

We already have a number of very innovative treatments in progress. For example, one of our approved studies involves deployment of cells via an Ommaya reservoir. This is a device that connects a port under the scalp via a tube directly into the ventricle of the brain where cells can be added to the cerebral spinal fluid. This concept evolved by working with renown Brain Surgeon, Christopher Duma, MD, FACS. It was preceded by safety studies on laboratory rats and 30 patients later is showing some significant progress.

As you can imagine, with new technologies, patients often come to you when theyve exhausted most other traditional treatments. Weve now had a lot of experience to understand how well cell therapy can work even though were continuing to gather data and look for ways of optimizing treatments. So, for example, most patients with arthritic knees will consider stem cell deployment after theyve tried pain medication, steroids, hyaluronan injections and even arthroscopy. None of these are actually treatments that repair the problem but rather mask the pain or temporize the situation. If theres cartilage in the knee then it can potentially signal your stem cells to repair the joint. We now understand that acute injuries probably respond better than chronic ones because there are more messages (cytokines) directing and instructing the stem cells into action and repair. Still, until we have enough data and publish enough articles to support these positions our concepts remain conjecture awaiting to be proven.

Patients are also concerned about whether these procedures are FDA approved. Technically, the FDA only approves drugs and devices. Were actually performing a surgical procedure and the FDA does not approve surgery. However, we are working with the FDA to have our system evaluated for potential FDA approval. Our initial FDA studies will be aimed at knee arthritis with the goal to show autologous SVF is more effective than a placebo. This will be done with a double blind controlled study. I doubt we will do FDA studies for every potential condition rather, doctors will ultimately gather data and/or do their own research and accumulate results to support the positive use of SVF for a large host of inflammatory and degenerative conditions.

Since starting our investigative network in 2012, weve not only gone to the animal lab for the Ommaya reservoir program, weve expanded our research into areas of cancer, paralysis, and most recently, concussion. My son, Sean, in fact, has been doing some terrific animal research in the area of concussion where hes been able to first, induce reproducible concussions in trained animals and show that they generally take two weeks to get better and re-learn their memory and motor skills; and second, by giving SVF via a tail vein injection after concussion, the rats get better so quickly that they regain their memory and motor skills right away. The implications for athletes, football especially, and the military are extraordinary.

There is a lot more information about our program that can be found at our website stemcellrevolution.com. Still, while this currently remains an area of investigation, it also represents one of the most exciting transitions in the field of medicine with tremendous potential now and in the future.

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Dr. Bermans's Stem Cell Therapy - Mark Berman MD

Stem Cell Treatments Flourish With Little Evidence That …

By Stem Cell Treatment

The companys website, loaded with impressive videos and testimonials from patients, is a major draw for aging gym rats searching the internet for relief from sore knees, shoulders, hips and backs.

Through the website, Dr. Centeno regularly criticizes other stem cell businesses, and has acted as an expert witness for injured patients suing his competitors.

The company did run afoul of the F.D.A. in 2008 over its use of cells cultured and multiplied in a lab to increase the stem cell count. After a protracted legal battle, Regenexx quit using that technique in the United States, but began offering it at a clinic on Grand Cayman.

This has always been about creating a less invasive orthopedic solution, what I call interventional orthopedics, Dr. Centeno said. He predicts a sea change in orthopedics similar to the revolution in cardiology, where much open-heart surgery was replaced by less invasive procedures.

While regulators may not consider them high risk, stem cell treatments involving bone marrow are not trivial. Collecting bone marrow involves forcefully puncturing the back of the hip bones in several spots, a painful process that requires local anesthesia. Then, pressure is applied to prevent bleeding, and the sites are bandaged to prevent infection.

Injecting the bone marrow or platelet extracts into the knee takes skill, even with X-rays to guide the needle. The injections can cause pain and irritation, and patients are usually sent home with leg braces that they will wear for a few weeks.

Sterile techniques are essential.

Whenever injections are administered to the joint, there is always a risk of introducing infection, said Dr. Kiran M. Perkins, who has investigated such illnesses at the Centers for Disease Control and Prevention. With stem cell treatments, she added, there are a lot of steps along the way where something could go wrong and you could have the introduction of microorganisms.

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Stem Cell Treatments Flourish With Little Evidence That ...

Stem-Cell Treatment for Blindness Moving Through Patient …

By Stem Cell Treatment

A new treatment for macular degeneration is close to the next stage of human testinga noteworthy event not just for the millions of patients it could help, but for its potential to become the first therapy based on embryonic stem cells.

This year, the Boston-area company Advanced Cell Technology plans to move its stem-cell treatment for two forms of vision loss into advanced human trials. The company has already reported that the treatment is safe (see Eye Study Is a Small but Crucial Advance for Stem-Cell Therapy), although a full report of the results from the early, safety-focused testing has yet to be published. The planned trials will test whether it is effective. The treatment will be tested both on patients with Stargardts disease (an inherited form of progressive vision loss that can affect children) and on those with age-related macular degeneration, the leading cause of vision loss among people 65 and older.

The treatment is based on retinal pigment epithelium (RPE) cells that have been grown from embryonic stem cells. A surgeon injects 150 microliters of RPE cellsroughly the amount of liquid in three raindropsunder a patients retina, which is temporarily detached for the procedure. RPE cells support the retinas photoreceptors, which are the cells that detect incoming light and pass the information on to the brain.

Although complete data from the trials of ACTs treatments have yet to be published, the company has reported impressive results with one patient, who recovered vision after being deemed legally blind. Now the company plans to publish the data from two clinical trials taking place in the U.S. and the E.U. in a peer-reviewed academic journal. Each of these early-stage trials includes 12 patients affected by either macular degeneration or Stargardts disease.

The more advanced trials will have dozens of participants, says ACTs head of clinical development, Eddy Anglade. If proved safe and effective, the cellular therapy could preserve the vision of millions affected by age-related macular degeneration. By 2020, as the population ages, nearly 200 million people worldwide will have the disease, estimate researchers. Currently, there are no treatments available for the most common form, dry age-related macular degeneration.

ACTs experimental treatment has its origins in a chance discovery that Irina Klimanskaya, the companys director of stem-cell biology, made while working with embryonic stem cells at Harvard University. These cells have the power to develop into any cell type, and in culture they often change on their own. A neuron here, a fat cell thereindividual cells in a dish tend to take random walks down various developmental paths. By supplying the cultures with fresh nutrients but otherwise leaving them to their own devices for several weeks, Klimanskaya discovered that the stem cells often developed into darkly pigmented cells that grew in a cobblestone-like pattern. She suspected that they were developing into RPE cells, and molecular tests backed her up.

Now that her discovery has advanced into an experimental treatment, Klimanskaya says she is excited by the hints that it may be able to preserve, and perhaps restore, sight. She recalls a voice mail she received during her second year at ACT: a person blinded by an inherited condition thanked her for her work, whether or not there was a treatment available for him. When you get a message like this, you feel like you are not doing it in vain, she says.

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Stem-Cell Treatment for Blindness Moving Through Patient ...

FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics …

By Stem Cell Clinics

The Food and Drug Administration has launched a nationwide crackdown on stem-cell clinics, issuing letters of warning and threatening civil actions that could shut them down if they refuse to comply with FDA regulations.

On Wednesday, the FDA sent correspondence to 20 clinics around the country, putting them on notice that they must seek FDA review and approval for their procedures.

Over the past 12 months, the FDA has sent regulatory correspondence to 45 clinics, according to The New York Times, which refers to them as rogue stem-cell clinics.

The regulatory crackdown is a paradigm change for more than 700 stem-cell clinics nationwide that have largely gone unregulated by federal authorities for over a decade.

The procedures being scrutinized include those that concentrate a patients own stem cells and re-inject them into that patientto treat a wide range of painful, debilitating illnesses such as herniated disks, joint pain, reproductive issues, Parkinsons disease, multiple sclerosis, and several others.

The FDA has filed civil actions against two clinics, one in Florida and another in California, in a bid to force them to comply with FDA regulatory regimes applied to major drug manufacturers. That would likely be unsustainable for small practices.

Advocates for regenerative stem-cell medicine charge that Big Pharmas influence is behind the crackdown, suggesting the FDA is being used to clear out potential competitors. They describe stem-cell therapy as a minimally invasive procedure best regulated by local medical boards.

The clinics maintain that because many of the treatments involve harvesting a patients own stem cells known as autologous stem cells and then re-injecting them into trouble spots in that patients own body, they should not be subject to FDA regulation.

Stem cells are undifferentiated, meaning they have the potential to grow into multiple types of bodily tissues. The clinics that use them in treatments maintain they reduce inflammation and promote healing.

Stem cells, they say, have been successfully used to treat thousands of patients, while critics point to cases where patients had adverse reactions including three Florida seniors with macular generation who reportedly suffered severe vision loss after stem-cells were injected into their eyes in a clinical trial, as reported in a March 2017 article in the New England Journal of Medicine.

One factor in the growing controversy: The question of when a procedure involving ones own tissues comes under the purview of federal regulators. Libertarian-minded medical ethicists argue the government should not be empowered to regulate patients decisions about their own medical treatment when it involves materials taken from, and reintroduced into, their own bodies.

Dr. Jeff Singer, a general surgeon in Phoenix who also serves as a senior fellow at the libertarian Cato Institute think tank, tells Newsmax that the FDA refrains from regulation in whats known as same surgery, when a tissue is removed from one part of the body and introduced somewhere else in the same patient. A skin graft would be an example.

But if the tissue is manipulated in some way, it begins to attract the FDAs attention, in part due to the concern the tissue could be somehow contaminated during the handling process.

If its what they call not the same surgery for example you take it and process it and then later on reinsert it into the patient they consider that sort of a creation of a drug, and they claim to have regulatory authority over it, Singer says.

This demarcation is particularly relevant in the case of adipose stem-cell treatments -- that is, stem cells that are derived from fatty deposits in the human body.

The procedure can be performed in just two hours under local anesthesia. An amount of fat approximately equivalent to a stick of butter is removed from the body. Enzymes are added to help the stems cells detach from the fat cells. The fatty material is then spun in a centrifuge to separate out stem cells, which are then collected and re-injected into the treatment areas of the patient.

Singer comments: The FDA considers that sort of like creating a medicine, and therefore it needs to come under their regulatory jurisdiction before its approved thats their position on it.

Singer would like the FDA to limit itself to certifying whether an autologous procedure has been proven to be safe and effective.

For example, he says, if the FDA wanted to say, We havent certified that this process is safe, proceed at your own risk, Im ok with that. But I still want to be able to make my own decision.

Of course patient safety is very important to Singer, but he points out federal regulators are hardly beyond making errors of their own. And he says the principle that the patient, not the government, must ultimately decide his or her own care also must be protected.

As Singer tells Newsmax: If I want to take my own tissue my own, not someone elses prepare it a certain way, and then put it back in my own body, thats as sacred as my right to free speech. From a medical ethics standpoint, its a patient autonomy question.

That the FDA sees things differently has become increasingly evident in recent years. Last December, for example, it issued a news release that warned: Time is running out for firms to come into compliance during our period of enforcement discretion. Well be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.

Perhaps no one in the stem-cell regenerative medicine business has come under greater scrutiny than Dr. Kristin Comella, chief science officer of U.S. Stem Cell, a firm that operates three clinics in South Florida.

Comella has helped train over 700 practitioners in her companys adipose stem-cell methodology, and U.S. Stem Cell has been recognized as a leader in its industry. Comella says the FDAs bid to regulate what patients choose to do with their own tissues is a case of regulatory overreach.

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FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics ...

Stem Cell Doctors in Auburn Novi MI| Chronic knee pain doctors in Auburn Novi

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Stem Cell Doctors in Auburn Novi MI| Chronic knee pain doctors in Auburn Novi

Doctors used stem cells to treat stroke symptoms …

By Stem Cell Doctors

Denis Balibouse/Reuters

A number of stroke survivors in a small trial showed significant improvements after doctors injected stem cells directly into their brains.

The study, published in the journal Stroke, was designed just to test whether the highly experimental therapy is safe, but the encouraging results raised doctors' hopes that it may eventually turn into a real treatment.

"This wasnt just, 'They couldnt move their thumb, and now they can,'" Dr. Gary Steinberg, the Stanford neurosurgeon who performed 12 of the stem cell procedures, said in a statement. "Patients who were in wheelchairs are walking now."

But the limited number of patients and the lack of a control group mean extreme caution is necessary in interpreting the results, which could be a fluke or the result of a placebo effect. And not all participants experienced such dramatic results. The trial was funded by the company that makes the potential treatment.

"I don't want people to get the idea that we've solved the problem, that this will make them walk again after stroke," Dr. Cathy Sila, a neurosurgeon who was not involved in the study, told VICE News. "The data does not demonstrate that."

Doctors were mostly looking to see if anyone had troubling side effects an important step before the testing of an experimental procedure can continue. But they also noticed patients had somewhat better movement after the injection, and that some patients who had been wheelchair-bound could walk again.

Each of the 18 patients had suffered a stroke up to five years before the trial began, and each had hit the limit in terms of how much physical therapy or rehabilitation could help them recover. A stroke happens when a blood vessel is blocked, cutting off oxygen to the brain and leaving parts of it damaged. These patients struggled to stand, walk, use their arms, or speak.

Scientists wanted to see if stem cells could help rebuild damaged areas of their brains or spur the brain to help repair itself. Each patient had donated stem cells injected directly into their brain near the damage caused by the stroke. According to the Washington Post, that's "relatively simple as far as brain surgery goes."

Most of the patients had headaches after the procedure, and some had other side effects like nausea and depression, but at least in this small group there was nothing severe. The stem cells that were injected are believed to only survive for about a month, something scientists gleaned from earlier studies in rats. But in the study patients, stronger motor skills were noticeable even a year after the treatment.

Scott Olson / Getty Images

Most people who survive a stroke experience lasting problems. Yet existing treatments only work if they are applied within hours of the stroke.

"At six months out from a stroke, you dont expect to see any further recovery," Steinberg said in the Stanford statement.

That's one reason doctors were so encouraged by what they observed in this small group: If the results hold up after further testing, it could make a real difference for patients.

The idea of using stem cells to treat stroke survivors has intrigued doctors for at least 10 years. There have been many attempts and different formulations of this potential treatment, andthey haven't been terribly successful so far.Yetmany studies are still ongoing, and injecting stem cellsdirectly into the brain is a much newer idea that certainlywarrants further research after these preliminary, encouraging results.

Still,don't expect stem cell injections for stroke to be widely available any time soon.

In the case of this latest study, it's unclear, one expert told the Washington Post, whether the stem cells themselves played any part in the perceived improvements. That's impossible to determine without a control group that receives a similar-seeming injection that doesn't actually contain stem cells. And there were far too few participants in the trial to make any real conclusions about how effective the treatment is; the study was designed only to look at safety.

Before stem cells could become a real treatment for stroke survivors, much larger, controlled studies are needed to show whether it really works and to see whether any scary side effects show up in a larger group. One trial that will eventually include about 150 patients is already underway.

While this kind of research takes many years (and usually does not pan out), doctors are encouraged by what they saw in the 18 patients in the trial. The resultssuggest that, at the very least, some of the faculties lost by stroke survivorsmay not actually be gone forever if only scientists can figure out how to restore them.

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Doctors used stem cells to treat stroke symptoms ...

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