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Registration of Human Stem Cell-based products ordered

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


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

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 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.

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.

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!

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?

Maxim Group Issues Stem Cell Sector Report on IntelliCell BioSciences Based on Treatment Process

NEW YORK, July 08, 2013 (eTeligis via ACCESSWIRE) -- IntelliCell BioSciences, Inc. (SVFC), a developer of novel, patented technology used to isolate stromal vascular fraction cells (stem cells) from adipose (fat) tissue. These cells are used to address the regenerative, curative and preventative conditions of disease, announced New York based Maxim Group has issued a research opinion on stem cell sector, and our position within the industry.

Jason Kolbert, the research analyst at Maxim Group commented in his report, IntelliCells position on the legal/regulatory status of SVFC (stromal vascular fraction cells) is that the product is a human cell, tissue, and cellular and tissue-based product (HCT/Ps) and is regulated under the regulations created under 21 C.F.R. 1271. The Company maintains that the SVFC product falls within the exemption from FDA regulation found under 21 C.F.R. 1271.15(b). This is because the HCT/Ps are removed from and reintroduced into the same patient during the same surgical procedure as that term is used in the practice of medicine. The cells that are reintroduced are exactly the same cells (i.e., such cells) as the cells removed from the autologous patient. Thus, the SVFC product falls under an exemption to FDA regulation.

Alternatively, even if the SVFC product is not exempt under 21 C.F.R. 1271.15(b), the company maintains that it meets the requirements in 21 C.F.R. 1271.10(a) for regulation solely under PHS Act 361 and Part 1271 as a 361 HCT/P and not as a drug, device, and/or biologic requiring an approved application. Under that section of the regulation, HCT/Ps that are from an autologous source, minimal manipulation, and for homologous use, and do not include added components (with some minor exceptions) are exempt from FDA pre-approval as a drug.

Under these guidelines IntelliCell Biosciences is empowering clinicians to treat patients today for everything from orthopedic injuries to multiple sclerosis. The company has treated over 300 patients and in some cases with dramatic results. We went so far as to review patients stories and case histories, publications and even met with the companys attorneys (ex-FDA reviewers) to understand the definitions of minimally manipulated and the legal guidelines by which the companys process allows physicians to treat patients. We left believing that this is the only company, at the moment that qualifies with a process that meets current guidelines.

To download the full report from Maxim group please visit http://www.filesanywhere user: Victor07 Password: Anna249249

Register for Mailing List

If you would like to be added to SVFC mailing list, receive updates, or submit a question to the company, please register online at http://www.wallstreetnewscast.com/request/svfc.html

About IntelliCell BioSciences

IntelliCell BioSciences is a Regenerative Medicine company developing novel technologies that address the regenerative, curative and preventative conditions of disease states with high unmet clinical needs. The Company has patented technology for the use of ultrasonic cavitation for separating stromal vascular fraction with stem cells from adipose tissue and several patent-pending. The Company is also pioneering the development of autologous and allogeneic cells from living and non-living tissue donors for research purposes. IntelliCell is planning a series of in-human clinical studies with top tier universities for the treatment of cardiac disease, osteoarthritis, multiple sclerosis, lower limb ischemic wounds, and gum regeneration in the oral cavity as well as medical aesthetics. The Company has developed a first class cGTP cellular processing facility in New York City, purpose built and designed to be fully integrated into an ambulatory surgery center and hospitals. http://www.intellicellbiosciences.com

Forward-Looking Statements

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Maxim Group Issues Stem Cell Sector Report on IntelliCell BioSciences Based on Treatment Process

Scéil Launches World’s First iPS Stem Cell Back-up Service

NEW YORK & LOS ANGELES--(BUSINESS WIRE)--

Scil is launching a service, the first of its kind, that allows individuals to benefit from 2012 Nobel Prize-winning medical research to store a backup of their adult selves literally freezing their healthy cells in time. Scils world-leading experts use cutting-edge techniques to take cells from a small sample of an individuals skin and reboot them at the "Day Zero state". These skin cells are processed into stem cells (iPS) that are stored long-term for potential future uses, which could repair damaged organs, rebuild tissue or fight disease, as personalised genetic-based medicine continues to develop.

Andr Choulika, CEO of Scil, said: Scil offers people the best possible chance in the future. People should be able to live young, no matter how old they grow. Scil gives them the opportunity to take advantage of the wave of regenerative medicine. Were offering the potential for people to use their cells for their cure as soon as regenerative medicine treatments become available.

iPS (induced pluripotent stem cells) are capable of developing into any cell type. They can be derived from adult cells at any time of life, but given the fast rate at which cell DNA degenerates (the human body accumulates about 1.8 million DNA mutations per second), Scils experts recommend taking this step sooner rather than later to ensure the healthiest possible cells are stored.

With the Scil service, the iPS cells are stored at -180C for as long as needed for potential future use as soon as regenerative medicine treatments become available. It is the first time ever that such a service has been made available to individuals commercially.

Regenerative medicine is the process of replacing or regenerating human cells, tissues and organs to restore or establish normal function or, by stimulating the body's own repair mechanisms, to heal previously irreparable tissues or organs.

The service is very simple and painless for the individual. A skin tissue sample is taken under local anaesthetic and by arrangement at your convenience. The skin cells are then rebooted into iPS cells by Scils world-leading biotechnology teams; and finally they are stored by Scil for a lifetime in cutting-edge laboratory conditions until they are needed for future medical applications as soon as they become available.

You can read more about Scil, the benefits of stem cell banking, and the leading role its parent company Cellectis plays in genetic research at http://www.sceil.com

About Scil

Scil, part of the Cellectis Group, delivers a service that allows individuals to freeze their adult stem cells and harness the future potential of regenerative medicine. Based on Nobel Prize-winning research, Scils world-leading experts use cutting-edge techniques to take cells from a small sample of an individuals skin and reset them at the Day Zero state. These skin cells are processed into induce pluripotent stem cells (iPS) that are stored long-term for potential future needs to repair damaged organs, rebuild tissue and fight disease as personalised genetic-based medicine continues to develop. For further information about Scil, please visit http://www.sceil.com

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Scéil Launches World’s First iPS Stem Cell Back-up Service

Michael – The Alliance for the Advancement of Adult Stem Cell Therapy and Research – Video


Michael - The Alliance for the Advancement of Adult Stem Cell Therapy and Research
The Alliance is here to assist people like Michael to receive adult stem cell treatment. Your donation WILL make a difference. If you #39;d like your donation to go to a specific person just mention...

By: TheStemCellAlliance

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Michael - The Alliance for the Advancement of Adult Stem Cell Therapy and Research - Video

6 things you need to know about stem cell therapy

by Buena Bernal Posted on 07/06/2013 9:06 PM |Updated 07/08/2013 2:15 PM

DOH ON STEM CELL. (Left) Health Secretary Enrique Ona and (right) FDA Director Kenneth Hartigan-Go talks to Rappler about stem cell therapy. Photos by Rappler/Naoki Mengua

MANILA, Philippines (UPDATED) Rappler talked to Department of Health (DOH) Secretary Enrique Ona and Food and Drug Administration (FDA) Director Kenneth Hartigan-Go to clarify the governments stance on stem cell therapy.

Stem cell therapy or regenerative medicine is a medical intervention that uses the bodys repair cells to substitute old cells. It is done for medical and aesthetic purposes that are still being investigated, according to the health secretary.

Asked why the treatment was allowed in the market despite no definitive curative and preventive benefits, FDA's Hartigan-Go said authorities never allowed the treatment to begin with.

Its just there. Now, the DOH under Secretary Ona's leadership took action," he said.

(READ: DOH: Stem cell therapy not yet proven to be curative)

On March 18, the DOH issued the rules and regulations for the accreditation of health facilities engaging in human stem cell and cell-based or cellular therapies in the Philippines.

The FDA has also released a circular on Monday, Jully 8, regarding the guidelines on registering stem cell-based products. The circular covers all products with a "claim, label, or poster" that says stem cells.

(READ: FDA Circular: Registration of Stem Cell-Based Products)

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6 things you need to know about stem cell therapy

U-M stem cell trial produces positive results for ALS patients

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U-M stem cell trial produces positive results for ALS patients