Stem Cell Clinic

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

By Stell Cell Research

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

By Stell Cell Research

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

By Uncategorized


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 Stem Cell Treatment

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

By Stem Cell Treatment

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

DOH: Stem cell therapy not yet proven to be curative

By Stell Cell Research

by Buena Bernal Posted on 07/06/2013 4:28 PM |Updated 07/08/2013 2:16 PM

STEM CELLS. Health Secretary Enrique Ona says stem cell therapy is a procedure still under clinical evaluation and study. Photo by Rappler/Naoki Mengua

MANILA, Philippines (UPDATED) Amid increasing interest in and the risks of stem cell treatment in the country, the health secretary said doctors are required to disclose to their potential patients that the procedure is still "investigative" its potential is still being explored, and there's no definite word that it can heal diseases.

This is in line with the ethical standards of medical practice that seek to empower patients with enough information prior to consenting to the treatment.

The patient must exactly know that he is part of an investigative process. And that is what we require as far as the Department of Health is concerned right now, Department of Health (DOH) Secretary Enrique Ona said in an interview with Rappler on Friday, July 5.

Stem cell therapy or regenerative medicine is the use of the bodys repair cells as a substitute to old cells that may cause debilitating diseases.

(READ: 6 things you need to know about stem cell therapy)

The treatment has gained controversy of late, after 3 unnamed high-profile politicians allegedly died due to botched procedures performed abroad. The deaths are currently being investigated by the Philippine Medical Association (PMA).

Not to stifle innovation

So why is the DOH encouraging the development of the science despite the treatment being under clinical evaluation and study?

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DOH: Stem cell therapy not yet proven to be curative

Deaths from stem cell RX

By Stell Cell Research

Heart to Heart Talk By Philip Chua Cebu Daily News

VARIOUS complications and even deaths (like those of the two Filipino politicians recently) have been reported following stem cell therapy. We are revisiting this issue to put in proper perspective the facts about this widely advertised form of therapy, which has been misrepresented and abused by some enterprising people.

What are stem cells?

The building block, the foundation cell, for every cell, tissue and organ in the body is the stem cell. Stem cells are undifferentiated, with no specific

assigned task as yet. This has been likened to a blank computer microchip that could be programmed to perform any number of special tasks. Subjected to proper conditions, stem cells will develop into

specialized tissues and organs (heart, liver, kidneys, etc). Also, stem cells are self-sustaining and can replicate themselves for long periods of time.

What is the controversy about?

Scientists, working on mouse models, have discovered that stem cell therapy could SOMEDAY possibly help cure many common diseases that afflict man today. Some of these include stroke, spinal cord injury, heart diseases, Parkinsons, Alzheimers, osteoarthritis, retinal degeneration and blindness, rheumatoid arthritis, liver and kidney diseases, burns, type 1 diabetes, and muscular dystrophies. While the goal of the stem cell research is unquestionably laudable, and its potential benefit to mankind tremendous, the controversy centers on its efficacy and safety today, ethical, moral, religious, legal and social ramifications.

Basically, the grave concerns are (1) The hype and claims are too premature and mostly untrue; (2) where the stems cells will be harvested from (adult, fetus or embryo), and (3) the possible misuse and abuse of this new technology. And I could not agree more.

As I have stated in my talk before the Rotary Club of Cebu last February, at CITE in Talamban, Cebu City, this evolving science merits more randomized, double-blind and voluminous clinical studies in various medical centers around the world before it becomes a standard in medical care. It also requires a deep soul-searching introspection, and a serious, intense, and thoughtful deliberation to arrive at a morally, ethically, and medically sound stem cell treatment protocol that will also ensure the protection of the unborn, besides healing the sick, and at the same time preserve the dignity of humankind it seeks to serve.

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Deaths from stem cell RX

Stem cell therapy can be done in PH — PMA President

By Uncategorized

Manila, Philippines -- Philippine Medical Association (PMA) President Dr. Leo Olarte said yesterday Filipinos need not go abroad or seek foreign consultation if they want to undergo stem cell therapy to cure an ailment.

Olarte warned of the risks and complications involved in stem cell therapy when improperly administered, citing the case of a government official who complained of feeling weak after the procedure was performed on him by a group of foreign medical team inside a posh hotel in Mandaluyong City.

The PMA chief said there are local experts who are capable of performing safe and reliable stem cell treatments in the country using the patient's own stem cells.

The other day, a lawyer for Dangerous Drugs Board (DDB) Chairman Antonio Villar faced the media and revealed that her client is filing charges against the foreign medical team who performed the procedure on him.

Lawyer Claire Pagayanan said the lead doctor who performed the stem cell therapy was from Germany while the other two doctors and nurses who assisted him were from Thailand.

Villar reportedly paid 15,000 euros or approximately P1.2 million for the procedure.

"Doctors who perform this therapy should be licensed by the Philippine Food and Drugs Administration. Before foreign doctors could perform here, they should apply for a license from the Professional Regulation Commission," he said. Those who fail to do so will be in "clear illegal practice of medicine in violation of the Medical Act of 1959," Olarte added.

For his part, PMA spokesperson Dr. Mike Aragon lamented how colonial mentality has affected the decision-making process of some Filipinos. "Maybe they are not well-informed about stem cell therapy, or it is the colonial mentality. Many of us think that if it is foreign, it is something good," Aragon said.

In the country, the only Department of Health (DoH)-approved stem cells that can be used for treatment are the patient's own stem cells harvested from his or her blood, bone marrow and fat.

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Stem cell therapy can be done in PH — PMA President

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