Stem Cell Clinic

Stemedica Advances to Phase II Stroke Trial with Lead Product Stemedyne-MSC

By adminJuly 10, 2013Stem Cell Treatment

San Diego, CA (PRWEB) July 10, 2013

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today the completion of enrollment and treatment of patients in a Phase I study with Stemedicas lead product Stemedyne-MSC. These specially formulated ischemic adult allogeneic mesenchymal stem cells have been manufactured at Stemedicas cGMP compliant facility and have been successfully used to treat patients in an ischemic stroke study: A Phase I/II, Multi-Center, Open-Label Study to Assess the Safety, Tolerability and Preliminary Treatment Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke.

The primary goal of the Phase I study was to assess the safety and tolerability of treatment with Stemedyne-MSC as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations in patients with a clinical diagnosis six months post ischemic stroke. The secondary goal was to assess the clinical effects of treatment on neurologic, functional, and motor deficits.

Fifteen patients were treated in this dose escalation Phase I study. Patients received one dose of Stemedyne-MSC via intravenous administration. An Independent Data Safety Monitoring Board reviewed safety data for subjects including adverse events, laboratory data and vital signs. Based on the review, they unanimously voted for the trial to proceed to Phase II.

Michael Levy, MD, PhD, FACS, the Principle Investigator and John Crawford, MD, Co-Investigator at the University of California, San Diego (UCSD) clinical site commented, We are optimistic that we will continue to see efficacy in Phase II based on improvements in levels of alertness and functional speech we have observed, especially in those patients with significant injuries.

Nabil Dib, MD, MSc, FACC, the Co-Investigator at the Mercy Gilbert Medical Center, Chandler Regional Medical Center in Gilbert, Arizona site commented, We are extremely excited about the Data Safety Monitoring Boards report on the first 15 patients treated and are encouraged by our preliminary observations of the improvements of the patients clinical symptoms. We look forward to completing patient enrollment into Phase II and the final analysis of this very important clinical trial. Cell therapy potentially has significant application in stroke patients that may change the way that we treat patients with cerebrovascular accidents.

Lev Verkh, PhD, Stemedicas Chief Regulatory and Clinical Development Officer, commented, Stemedica achieved this significant milestone by demonstrating the safety of the product at all doses studied in this trial. We are also encouraged that this treatment resulted in clinical benefits in patients with this diagnosis. The Phase II portion of this trial is open for enrollment (http://clinicaltrials.gov/ct2/results?term=stemedica).

Nikolai Tankovich, MD, PhD, FASLMS, President and Chief Medical Officer of Stemedica noted, Our current and planned clinical trials are directed toward the entire spectrum of ischemic disease, from the early onset of the vascular damage in metabolic syndrome, to the acute damage of myocardial infarction and chronic damage as evidenced by the stroke patients in this trial. By expanding Stemedyne-MSC cells in our proprietary low oxygen process, we produce MSCs that have higher levels of the critical factors necessary for vascular repair as compared to cells expanded in normal oxygen.

More than 800,000 Americans suffer a stroke annually and according to the American Heart Association, stroke is the fourth leading cause of death - costing an estimated $73.7 billion in 2010 for stroke-related medical costs and disability.

About Stemedica Cell Technologies, Inc. http://www.stemedica.com Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke, cutaneous photoaging and acute myocardial infarction. Additional information can be found at http://www.clinicaltrials.gov. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

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Stemedica Advances to Phase II Stroke Trial with Lead Product Stemedyne-MSC

Stem cell therapy: Future of medicine?

By adminJuly 10, 2013Stem Cell Treatment

by Rappler.com Posted on 07/09/2013 9:42 PM |Updated 07/10/2013 3:51 PM

MANILA, Philippines - Everyone is talking about stem cell therapy. But scammers and swindlers are also taking advantage of the fad, prompting the Health Department to step in. Buena Bernal reports.

Its the new medical buzzword in the Philippines. Stem cell therapy is a procedure which uses repair cells found in the body to replace old cells. Dr Florencio Lucero started doing the procedure 6 years ago.

DR FLORENCIO LUCERO, STEM CELL TRANSPLANT SURGEON: Stem cells can help degenerative diseases. Some people who have serious illnesses, and they cannot find any solution to their condition, they seek this kind of treatment, because it can improve their condition. But not a cure. It cannot cure.

Pilar Vazquez who went through a mild stroke says she felt energized after undergoing the treatment.

PILAR VAZQUEZ, STEM CELL TRANSPLANT PATIENT: Stem cell is very good. I did not feel pain or what. Everything is very good. Before, I dont [always] talk. Now, I always talk. Thats a very good difference, because now they say, Ay si Mommy, ang galing galing niyan, parating nagsasalita!

But stem cell therapy became controversial after 3 government officials allegedly died from the treatment, while another official filed charges against his German doctor for his botched treatment last year. Food and Drug Administration director Dr. Kenneth Hartigan Go says right now, stem cell therapy is allowed but under investigation.

DR KENNETH HARTIGAN-GO, DIRECTOR, FOOD AND DRUG ADMINISTRATION: We are keeping an objective mind and saying, okay, if this is investigational, go ahead. And then we have to see outcome, say, within a period of a time whether the product actually works or not.

The Department of Health cautions the public from engaging in prohibited forms of the treatment -- those that are performed outside accredited facilities and those that source stem cells from human embryos. Health Secretary Enrique Ona says he does not want to stifle the innovation but there must be regulation.

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Stem cell therapy: Future of medicine?

Sports Medicine and Stem Cells: Athletes are ready for New Era of Treatment

By adminJuly 10, 2013Stem Cell Treatment

TAMPA, Fla., July 9, 2013 /PRNewswire/--As new medical frontiers are forged, their place in sports medicine will be assured if athletes can recover or heal faster. This concept has not been lost in the dawn of Regenerative Medicine. This new age has emerged in which regenerative stem cell treatments are being applied to blindness, spinal cord injuries and congestive heart failure. It is no wonder that elite athletes such as Peyton Manning turned to stem cells when his neck wasn't healing. http://www.drlox.com

So what is it that makes the allure of stem cells attractive to high caliber athletes? According to Dr. Dennis Lox, a Sports Medicine and Regenerative specialist, in the Tampa Bay, Florida area, stem cells have unique capabilities for injured athletes. First the stem cells are very effective at alleviating inflammatory responses seen in chronic injuries. By blocking and altering the mechanisms in which inflammation occurs, some chronic injuries may heal. Dr. Lox then comments that, the stem cells are also at the same time regenerative cells that may heal by releasing factors that allow healing to occur, or trophic effects. Lastly, the stem cells may allow regeneration of injured tissue. All these mechanisms, Dr. Lox stresses, cannot be achieved by cortisone injections, or commonly prescribed anti-inflammatory medications. http://www.drlox.com

The unique way in which regenerative therapies such as Platelet Rich Plasma (PRP) and stem cells, exert effects on injured tissues will always be seen positively as athletes search for better and quicker healing treatments. Also, athletes need to be concerned with career longevity. The possible fountain of youth that repairing injured muscles and joints may hold with stem cell therapy makes it an attractive option. No adverse effects have been reported in clinical trials using stem cells for knee arthritis. The same cannot be said for knee surgery. The upside to minimizing further joint injury by avoiding surgery, may deter accelerated arthritis development. Dr. Lox notes a player's career may be lengthened by early repair of knee injury, and preventing arthritis development. These are two goals of regenerative medicine, and in some athletes mind two reasons to consider stem cell therapy.

About Dr. Dennis Lox Dr. Lox practices in the Tampa Bay Florida area. Dr. Lox is a Sports and Regenerative Medicine Physician, who specializes in the use of regenerative and restorative medicine to assist in treating athletic and arthritis conditions. Dr. Lox may be reached at (727) 462-5582 or visit Drlox.com.

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Sports Medicine and Stem Cells: Athletes are ready for New Era of Treatment

Microparticles create localized control of stem cell differentiation

By adminJuly 10, 2013Stell Cell Research

Javascript is currently disabled in your web browser. For full site functionality, it is necessary to enable Javascript. In order to enable it, please see these instructions. Jul 09, 2013 Georgia Tech/Emory University Associate Professor Todd McDevitt and graduate student Anh Nguyen make microparticles to be used for delivering growth factors to stem cells. Credit: Rob Felt

Before scientists and engineers can realize the dream of using stem cells to create replacements for worn out organs and battle damaged body parts, they'll have to develop ways to grow complex three-dimensional structures in large volumes and at costs that won't bankrupt health care systems.

Researchers are now reporting advances in these areas by using gelatin-based microparticles to deliver growth factors to specific areas of embryoid bodies, aggregates of differentiating stem cells. The localized delivery technique provides spatial control of cell differentiation within the cultures, potentially enabling the creation of complex three-dimensional tissues. The local control also dramatically reduces the amount of growth factor required, an important cost consideration for manufacturing stem cells for therapeutic applications.

The microparticle technique, which was demonstrated in pluripotent mouse embryonic cells, also offers better control over the kinetics of cell differentiation by delivering molecules that can either promote or inhibit the process. Based on research sponsored by the National Institutes of Health and the National Science Foundation, the developments were reported online July 1 in the journal Biomaterials and were presented at the 11th Annual International Society for Stem Cell Research meeting held in Boston June 12-15, 2013.

"By trapping these growth factors within microparticle materials first, we are concentrating the signal they provide to the stem cells," said Todd McDevitt, an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. "We can then put the microparticle materials physically inside the multicellular aggregate system that we use for differentiation of the stem cells. We have good evidence that this technique can work, and that we can use it to provide advantages in several different areas."

The differentiation of stem cells is largely controlled by external cues, including morphogenic growth factors, in the three-dimensional environment that surrounds the cells. Most stem cell researchers currently deliver the growth factors into liquid solutions surrounding the stem cell cultures with a goal of creating homogenous cultures of cells. Delivering the growth factors from microparticles, however, provides better control of the spatial and temporal presentation of the molecules that govern the growth and differentiation of the stem cells, potentially allowing formation of heterogeneous structures formed from different cells.

Groups of stem cells stick together as they develop, forming multicellular aggregates that form spheroids as they grow. The researchers took advantage of that by driving microparticles containing growth factor BMP4 or noggin which inhibits BMP4 signaling into layers of stem cells using centrifugation. When the cell aggregates formed, the microparticles became trapped inside.

The researchers used confocal imaging and flow cytometry to observe the differentiation process and found that growth factors in the microparticles directed the cells toward mesoderm and ectoderm tissues just as they do in solution-based techniques. But because the BMP4 and noggin molecules were directly in contact with the cells, much less growth factor was needed to spur the differentiation approximately 12 times less than what would be required by conventional solution-based techniques.

"One of the major advantages, in a practical sense, is that we are using much less growth factor," said McDevitt, who is also director of the Stem Cell Engineering Center at Georgia Tech. "From a bioprocessing standpoint, a lot of the cost involved in making stem cell products is related to the cost of the molecules that must be added to make the stem cells differentiate."

Beyond more focused signaling, the microparticles also provided a localized control not available through any other technique. That allowed the researchers to create spatial differences in the aggregates a possible first step toward forming more complex structures with different tissue types such as vasculature and stromal cells.

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Microparticles create localized control of stem cell differentiation

FDA bans stem cells from animals, plants

By adminJuly 10, 2013Stell Cell Research

MANILA, Philippines - Stem cells taken from animals and plant derivatives are not allowed in the country, according to a circular of the Food and Drug Administration (FDA).

In FDA Circular 2013-017, FDA acting director Kenneth Hartigan-Go said stem cells harvested from human embryos for research purposes, human embryonic stem cells and their derivatives as well as aborted human fetal stem cells and their derivatives are also not authorized.

Go said such stem cells are prohibited from creation, importation, promotion, marketing and use.

This means that selling and manufacturing of soap and other products that supposedly contain stem cells from placenta and animals, which have been flooding the market recently, are also prohibited.

The FDA circular said imported human stem cell-based products are allowed, provided they are not hand-carried and meet other requirements.

The FDA requires the use of appropriate mode of transportation and storage in transporting allogeneic stem cells or those derived from other humans and not the patient himself.

Under the guidelines previously issued by the Department of Health (DOH), only autologous stem cells, or those taken from the patients themselves, are acceptable.

In Circular 2013-012 issued last May 15, the FDA had also warned the public against receiving unapproved stem cell preparations in non-health facilities.

The agency said unapproved stem cell preparations and therapy without prior FDA-DOH approval could cause infectious diseases and severe complications which may lead to permanent disabilities, physical deformities, autoimmune diseases and even death, without the benefit of health insurance coverage.

Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

By adminJuly 10, 2013Stell Cell Research

LOS ANGELES--(BUSINESS WIRE)--

The HIV gene medicines company Calimmune announced today that the first patient has begun treatment in a Phase I/II clinical trial designed to determine whether a pioneering genetic medicine approach can help to protect individuals infected with HIV from the effects of the virus. The study, Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection, utilizes a gene medicine called Cal-1, developed in the lab of Nobel Laureate Dr. David Baltimore and by Calimmune.

In the study, 12 HIV-positive participants will be infused with their own T cells and stem cells (hematopoietic stem cells, HSC), which have been modified to block the HIV receptor CCR5, and to prevent HIV fusion. The procedure is designed to prevent the virus from entering and damaging protected cells. The dual approach used in the study is designed to reduce the possibility that HIV can develop resistance to the procedure.

The goal of the study is to assess the safety, feasibility and tolerability of Cal-1 in HIV-infected individuals who have previously been on highly active antiretroviral therapy (HAART) but are not currently taking any antiretroviral agent. In addition to routine clinical and laboratory assessments to monitor general health and HIV infection, the study will monitor the presence of Cal-1 protected cells in various cell types in the blood and lymphoid tissue. Other analyses will monitor the safety of Cal-1. The first patient was treated in the study in late June. Data from this study are expected in 2015.

All participants in the studys three arms will receive the Cal-1 gene transfer. Participants in two of the three study arms will also receive different doses of a preconditioning drug known as busulfan, which may make the therapy more effective.

This study is an early but important step in an emerging area of scientific exploration, representing the culmination of more than a decade of research and development, said Calimmune Chief Executive Officer Louis Breton. We are optimistic that what we learn from this study may bring us closer to the day when a one-time treatment could provide an alternative to a lifetime of antiretroviral therapy.

The study has been partially funded by the California Institute for Regenerative Medicine (CIRM). The study will take place at clinical trial sites in Los Angeles and San Francisco, Calif., under the direction of Principal Investigators Ron Mitsayasu, M.D., of UCLA and Jacob P. Lalezari, M.D., of Quest Clinical Research.

For more information, visit http://www.clinicaltrials.gov.

About Calimmune

Calimmune is a clinical-stage HIV gene medicines company focused on developing innovative cell-based therapies for HIV. The companys stem cell technology was discovered in the labs of Nobel Laureate Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute). Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

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Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

Registration of Human Stem Cell-based products ordered

By adminJuly 10, 2013Stell Cell Research

The Food and Drug Administration (FDA) has ordered the registration of human stem cell and cell-based or cellular therapies in the country.

"Pursuant to Administrative Order 2013-0012 known as 'Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Stem-Cell Based or Cellular Therapies in the Philippines' strengthening of the regulatory framework to ensure access to safe and quality health facilities engaging in human stem cell and cell-based or cellular therapies in the Philippines has been promulgated," the FDA said.

It said the circular "does not cover cellular or cell-based therapeutic products intended to replace blood volume or alter the coagulative properties of blood."

The order also does not cover human embryos for research, human embryonic stem cells, aborted human fetal stem cells and plant parts labeled as stem cell as the creation, importation, promotion and marketing of these products are banned in the country.

Stem-cell based products of animal origin are also prohibited from being registered with the FDA.

Under the guidelines, companies have to submit various documents, including the good manufacturing practice certificate of the stem-cell based manufacturer, information of the product and its manufacture and scientific evidence to support each claimed indication, copy of marketing authorization from the national regulatory authority of the exporting country, claimed shelf-life and stability studies, list of countries where the product is already approved and date of approval. (With a report from Jenny F. Manongdo)

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Registration of Human Stem Cell-based products ordered

Stem Cell Therapy Treatment for Duchenne Muscular Dystrophy by Dr Alok Sharma, Mumbai, India. Part 2 – Video

By adminJuly 9, 2013Uncategorized

Stem Cell Therapy Treatment for Duchenne Muscular Dystrophy by Dr Alok Sharma, Mumbai, India. Part 2
Improvement seen in just 3 months after Stem Cell Therapy Treatment for Duchenne Muscular Dystrophy by Dr Alok Sharma, Mumbai, India. After Stem Cell Therapy...

By: Neurogen Brain and Spine Institute

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Stem Cell Therapy Treatment for Duchenne Muscular Dystrophy by Dr Alok Sharma, Mumbai, India. Part 2 - Video

Intercellular Sciences Releases New Case Study on Stem Cell Treatment and its Effects on Strokes

By adminJuly 9, 2013Stem Cell Treatment

Bonita Springs, FL (PRWEB) July 08, 2013

Karen Anderson was hoping that her husband John, 62, would see an improvement in his damaged heart following stem cell treatment in the Dominican Republic, and he did. His heart function improved and he was able to return to how he was before his heart went bad.

What Karen didnt expect was that his stroke would get better too. So much better that he can now drive for the first time since his stroke. Johns response to the stem cell treatment has just been amazing, nothing short of a miracle, Karen says. John had been struggling with severe deficits since his stroke two and a half years ago. He could not finish a sentence, do simple math, write words or even say his wifes name correctly. Now he can carry on conversations, add up the tip on a restaurant bill and most impressively safely drive the family car, which became very important when Karen broke her foot and John had to drive her around.

I never thought our roles would reverse and John would be taking care of me, but thanks to his stem cell therapy he is returning back to the man he was. Karens big smile says it all.

Strokes are usually blood clots that travel to the brain, block an artery and cause loss of brain function and paralysis. Stroke is a leading cause of death in the United States, killing nearly 130,000 Americans each yearthats 1 of every 18 deaths. This is devastating to not only the patient but also to their family.

John C. (age 62, Dickson, TN), has had Cardiomyopathy (weak heart) since he was a young man. First diagnosed while in college, he has had to adjust his life style, adapting it to his weak heart function. His doctors recommended a defibrillator a few years ago and he has been dependent on it ever since. Then, in 2010, he suffered a massive stroke which left him quite disabled. His heart symptoms also rapidly worsened. Due to severe shortness of breath and fatigue, he had to stop many of his activities; even walking up his driveway had become impossible. Johns heart ejection fraction (the percent of pumping of the heart) had dropped to under 10%. His doctors were not optimistic. He and his wife Karen refused to accept such a grim fate and searched for alternative treatment. They soon found an option: adult stem cell therapy.

Zannos Grekos MD, MAAC, FACC, chief science officer of Intercellular Sciences and a Florida-based pioneer in the field of adult stem cell therapy describes how stem cells from the patient are extracted and activated in a laboratory. These cells we call Regenocytes. Dr. Zannos G. Grekos explains how, in this groundbreaking treatment, cardiologist Doctor Hector Rosario, Chief of Interventional Therapy for Intercellular Sciences, inserts a catheter into the patients heart similar to a heart catheterization to inject the stem cells. The process of tissue repairing the damaged heart begins almost immediately. Since these stem cells are the bodys natural healing cells, some of those stem cells go to other parts of the body and start to repair damage. When this happens we can see some amazing improvement in areas we hadnt targeted. Things like arthritis or diabetes get better, even stroke symptoms like in this patient says Grekos, who has been treating patients with stem cells since 2006.

I have much more energy now, said John after his treatment. Im back to walking the perimeter of my 6 acre property and back at cardiac rehab. I have even started bowling again which I had stopped. An echocardiogram performed by his cardiologist 3 months after his treatment showed that his heart function had doubled.

ABOUT ZANNOS GREKOS, MD, MAAC, FACC:

Dr. Zannos Grekos is an Interventional Cardiologist and specialist in stem cell research and treatment. Dr. Grekos has extensive experience in the field of stem cell therapy. In collaboration with major treatment and research centers, he has developed many of the protocols used for adult stem cell therapy throughout the world. Dr. Zannos Grekos also trains physicians in the evaluation and treatment of patients receiving stem cell therapy. He was appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute. Dr. Zannos Grekos was invited to Washington, DC to brief the United States Senate Health Advisory staff in 2007. Dr Grekos lectures and educates both nationally and internationally on the current clinical status of stem cell therapy.

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Intercellular Sciences Releases New Case Study on Stem Cell Treatment and its Effects on Strokes

Stem cell therapy future of medicine?

By adminJuly 9, 2013Stem Cell Treatment

by Rappler.com Posted on 07/09/2013 9:42 PM |Updated 07/09/2013 10:20 PM

MANILA, Philippines - Everyone is talking about stem cell therapy. But scammers and swindlers are also taking advantage of the fad, prompting the Health Department to step in. Buena Bernal reports.

Stroke survivor Pilar Vasquez says she felt energized after undergoing the treatment.

PILAR VASQUEZ, STEM CELL TRANSPLANT PATIENT: Stem cell is very good. I did not feel pain or what. Everything is very good. Before, I dont talk. Now, I always talk. Thats a very good difference, because now they say, Ay si Mommy, ang galing galing niyan, parating nagsasalita!

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Stem cell therapy future of medicine?