Italy approves law on controversial stem cell therapy

ROME: Italian lawmakers on Wednesday gave their final approval to a law that allows limited use of a controversial type of stem cell therapy which has been condemned by many scientists but has given hope to families of terminally-ill children.

The law gives the go-ahead for therapy being carried out by the Stamina Foundation on dozens of patients to continue, and allows for an 18-month period of clinical trials for the procedure, which had previously been blocked by Italian authorities.

The bill was amended from an earlier version and states the therapy must be carried out under regulatory oversight and using cells made according to the Good Manufacturing Practice (GMP) which the Stamina Foundation has not adhered to.

The Stamina Foundation says its treatment is based on mesenchymal stem cells and could treat diseases like spinal cord injury and motor neurone disease.

But leading scientists have warned that there is no evidence to suggest the treatment could work and no way to know that it will not cause harm.

Patients lobbied for the therapy to be given the go-ahead, receiving support from various celebrities including actress Gina Lollobrigida.

At one demonstration, protesters wore T-shirts with the slogan: "Yes to Stamina, Yes to Life".

The association Stem Cell Research Italy has branded the new law as "unacceptable" saying the therapy was not backed up by clinical data published in peer-reviewed academic journals.

US journal Nature said it was a "rogue" therapy.

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Italy approves law on controversial stem cell therapy

Italy approves controversial stem cell therapy

Italian lawmakers on Wednesday gave their final approval to a law that allows limited use of a controversial type of stem cell therapy which has been condemned by many scientists but has given hope to families of terminally-ill children.

The law gives the go-ahead for therapy being carried out by the Stamina Foundation on dozens of patients to continue, and allows for an 18-month period of clinical trials for the procedure, which had previously been blocked by Italian authorities.

The bill was amended from an earlier version and states the therapy must be carried out under regulatory oversight and using cells made according to the Good Manufacturing Practice (GMP) which the Stamina Foundation has not adhered to.

The Stamina Foundation says its treatment is based on mesenchymal stem cells and could treat diseases like spinal cord injury and motor neurone disease.

But leading scientists have warned that there is no evidence to suggest the treatment could work and no way to know that it will not cause harm.

Patients lobbied for the therapy to be given the go-ahead, receiving support from various celebrities including actress Gina Lollobrigida.

At one demonstration, protesters wore T-shirts with the slogan: "Yes to Stamina, Yes to Life".

The association Stem Cell Research Italy has branded the new law as "unacceptable" saying the therapy was not backed up by clinical data published in peer-reviewed academic journals.

US journal Nature said it was a "rogue" therapy.

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Italy approves controversial stem cell therapy

Scientists warn against risking cerebral palsy stem cell treatment overseas

An expert panel of scientists and clinicians is warning people against going overseas for costly and unproven stem cell treatment for cerebral palsy.

A forum held in Sydney last night heard from leading researchers in the field and a parent who sought treatment in the United States for his young son.

The Cerebral Palsy Alliance estimates as many as 500 Australians have sought stem cell therapies overseas.

But the alliance last night urged families to hold out for the possibility that Australia will undertake its own clinical trials of the treatment as early as this year.

"We're very worried about families travelling overseas for treatment," Associate Professor Iona Novak, from the alliance, said.

"A lot of these stem cell tourism companies don't even describe what type of cells they're giving, so first we don't even know if they're human cells... so, of course, it is a very risky procedure.

"There has been a couple of cases internationally of children actually dying from these treatments."

The alliance estimates a child in Australia is born with cerebral palsy every 15 hours, making it the most common disability in childhood.

The condition is caused by damage to the child's brain during pregnancy, birth or soon after.

It often leads to seizures, blindness, hearing loss and slower developmental growth.

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Scientists warn against risking cerebral palsy stem cell treatment overseas

BioRestorative Therapies, Inc. to Present at the Marcum MicroCap Conference

JUPITER, Fla., May 21, 2013 /PRNewswire/ --BioRestorative Therapies, Inc. ("BRT" or the "Company") (OTC BB: BRTX), a life sciences company focused on developing stem cell based therapies for various personal applications, announced that Mark Weinreb, its President and CEO, will be presenting at the Marcum MicroCap Conference.

The conference will be held on Thursday, May 30, 2013 at the Grand Hyatt Hotel, located at 109 E 42nd Street in New York City. Mr. Weinreb's presentation will take place at 2:30 ET in room six. To listen to the webcast, please visit http://wsw.com/webcast/marcum/brtx.

The event will host nearly 100 publicly traded companies with capitalizations under $500 million. It is anticipated that the conference will be attended by more than 1,000 persons, including senior personnel from the presenting public companies, leading institutional investors, directors, bankers and service providers to the microcap marketplace. The conference will also feature panels on subjects highly relevant to small-cap corporate finance.

For full event details and registration information, please go to: http://www.marcumllp.com/microcap

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. ("BRT"), http://www.biorestorative.com, develops medical procedures using cell and tissue protocols, primarily involving adult stem cells, designed for patients to undergo minimally invasive cellular-based treatments. BRT is developing the following scientific initiatives:

The Company also offers plant stem cell-based facial creams and beauty products under the Stem Pearls brand at http://www.stempearls.com.

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

Investor Contact:Jeff Ramson ProActive Capital (646) 863-6341 jramson@proactivecapital.com

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BioRestorative Therapies, Inc. to Present at the Marcum MicroCap Conference

Plea for a Correct Use of Stem Cells in Therapy

Newswise The Stem Cell Research Italy Association (www.stemcellitaly.org) and the Sbarro Health Research Organization (www.shro.org) make a public plea for a correct use of stem cell therapy in Italy and Europe.

Stem Cell Research Italy (SCR Italy) strongly endorses the point of view of eminent scientists who published a commentary on the regulation of stem cell therapy in Europe (Bianco et al Regulation of stem cell therapies under attack in Europe: for whom the bell tolls EMBO J. 2013 May 3. doi: 10.1038/emboj.2013.114).

In the present plea SCR quotes the hot topic issues that were addressed in the commentary.

The Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation.

It must be underlined that stem cells are not a homogeneous class of cells; stem cells are not one-size-fits-all cures. There are different kinds of stem cells in different tissues, and even when the appropriate stem cell is selected for an indication it takes years of research to learn how to administer the stem cell safely and effectively.

Empiricism as a productive approach in medicine is often invoked as a reason to conduct trials with stem cells, blind of any putative mechanism of action.

Conducting formal, regulated, transparent clinical trials using stem cells can be legitimate, even if based on a partial or weak rationale. It is also, however, expensive and highly likely to be uninformative. Scientific approach must be robust before one embarks on a clinical trial. Mechanistic insight is not a dispensable intellectual luxury. It is specifically required to develop effective therapies. It is to this end that we need mechanisms and rationale.

A model of translational medicine has been subliminally accepted by many scientists. The scheme is driven by the pressure to effect the rapid translation of data from the bench. Premature translation of provisional data and concepts in the stem cell field, in conjunction with loosened regulation, can perhaps bring to the market products, but cannot provide solutions for diseases.

On this premise, scientists must clearly inform public opinion and authorities on the potential risks of stem cell therapy to avoid media campaign vowing the right of sick people to have access stem cell therapy for compassionate use. It has to be firmly rejected the argument offered by media and public opinion of a compassionate use of stem cells: there is no compassion without safety and efficacy. Exposing the weakest people to unknown risks is ethically unacceptable. Recourse to unproven and unsafe therapy is said to be compassion, or to fall into an arbitrary category of compassionate treatment. This is not the case at all. Compassion only applies when one offers a safe and potentially effective remedy. That a remedy is effective must be supported by published clinical data. If such data are not available, there is no legitimate assumption of effectiveness in the individual patient, and therefore no compassion.

In conclusion SCR Italy strongly agree with the notion that only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients.

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Plea for a Correct Use of Stem Cells in Therapy

YFRM Technologies, Inc. Completes Acquisition of the Integrative Stem Cell Institute

PITTSTON, ME--(Marketwired - May 21, 2013) - YaFarm Technologies, Inc. (PINKSHEETS: YFRM) (YaFarm) is pleased to announce the completion of its acquisition of the Integrative Stem Cell Institute (the ISCI). The new company, to be called "the Integrative Stem Cell Institute," will continue the pioneering work of the ISCI in the field of cell-based regenerative medicine. The ISCI will be housed in Cancun's Hospital Galenia and will combine a world-class medical facility with a state-of-the-art laboratory in the investigational treatments of patients with chronic and degenerative diseases as part of controlled clinical studies.

The new company will provide point-of-care therapies based upon cell-based, regenerative medicine. The company will focus on the treatment of patients with limited or no options, and who suffer from diseases for which current medicine provides little or no alleviation. The ISCI combines a state-of-the-art, ISO 7 laboratory with cell-based treatments and nutritional, occupational, physical and hyperbaric oxygen therapies to provide a unique and highly integrative medical approach.

Juan Castillo, MD, founder of the ISCI, said, "Combining these two companies has allowed the ISCI to advance quickly into a global leadership position in this emerging field. Regenerative medicine is the future of patient care." Dr. Castillo continued, "Physicians from around the world have used stem cells to treat thousands of patients with diseases such as MS, Parkinson's and autism. Our methods, combined with an interdisciplinary team of physicians, provide a new benchmark for quality patient care."

YaFarm has requested shares of its stock be issued to members of the ISCI management, which will give them controlling interest, and made arrangements for delivery of books and records. As a result of the transaction, Brian Hermenze and Cody McDowell have resigned from the Board and as President and Chief Executive Officer. Dr. Juan Casteel, Elizabeth Casteel, and David Kugelman have been appointed to the Board of Directors.

About Integrative Stem Cell Institute (ISCI)The Integrative Stem Cell Institute (ISCI) is a premier provider of point-of-care, stem cell-based therapies for patients from around the world. With a state of the art laboratory housed within the Hospital Galenia in Cancun, Mexico, the ISCI combines the most advanced scientific application of stem cells with second to none medical care within the structure of adaptive clinical trials to effectively track long term outcomes and assure patient safety.

More information on The Integrative Stem Cell Institute is available on the company's website at http://www.iscelli.com.

SAFE HARBOR STATEMENT

This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition, adequate financing, and other material risks. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance, or achievements to be materially different from the statements made herein.

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YFRM Technologies, Inc. Completes Acquisition of the Integrative Stem Cell Institute

Stem-cell treatment restores sight to blind man

An experimental stem-cell treatment has restored the sight of a man blinded by the degeneration of his retinal cells. The man, who is taking part in a trial examining the safety of using human embryonic stem cells (hESCs) to reverse two common causes of blindness, can now see well enough to be allowed to drive.

People undergoing treatment had reported modest improvements in vision earlier in the trial, which began in 2011, but this individual has made especially dramatic progress. The vision in his affected eye went from 20/400 essentially blind to 20/40, which is considered sighted.

"There's a guy walking around who was blind, but now can see," says Gary Rabin, chief executive officer of Advanced Cell Technology, the company in Marlborough, Massachusetts that devised the treatment. "With that sort of vision, you can have a driver's licence."

In all, the company has so far treated 22 patients who either have dry age-related macular degeneration, a common condition that leaves people with a black hole in the centre of their vision, or Stargardt's macular dystrophy, an inherited disease that leads to premature blindness. The company wouldn't tell New Scientist which of the two diseases the participant with the dramatic improvement has.

In both diseases, people gradually lose retinal pigment epithelial (RPE) cells. These are essential for vision as they recycle protein and lipid debris that accumulates on the retina, and supply nutrients and energy to photoreceptors the cells that capture light and transmit signals to the brain.

The company is testing treatments for both conditions by turning hESCs into fresh RPE cells, then giving each trial participant a transplant of the cells beneath the retina in one eye.

Although the aim of the trial is primarily to check that the stem cells are safe, participants have reported improvements in their sight. The company intends to publish the outcomes in full when all the results are in.

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Stem-cell treatment restores sight to blind man

Blind man's sight restored by stem cell treatment

A blind man had his vision restored by an experimental stem cell treatment -- going from 20/400 to 20/40.

Intermediate age-related macular degeneration in a human eye. (Credit National Eye Institute/National Institutes of Health)

People undergoing an experimental stem-cell treatment have experienced modest improvements in their vision since the trial began in 2011, but one man had his vision restored from 20/400 -- basically blind -- to 20/40.

"There's a guy walking around who was blind, but now can see," said Gary Rabin, CEO of Advanced Cell Technology, the Massachusetts company that devised the treatment. "With that sort of vision, you can have a driver's license."

The man was taking part in a trial examining the safety of using human embryonic stem cells (hESCs) to reverse two common causes of blindness, reports New Scientist.

In all, ACT has treated 22 patients who either have dry age-related macular degeneration, a common condition that leaves people with a black hole in the centre of their vision, or Stargardt's macular dystrophy, an inherited disease that leads to premature blindness.

In both diseases, people gradually lose retinal pigment epithelial (RPE) cells. These cells recycle protein and lipid debris that accumulates on the retina, and supply nutrients and energy to photoreceptors -- the cells that sense light and transmit signals to the brain.

The company is testing treatments for both conditions by turning hESCs into new RPE cells, then giving each trial participant a transplant of the cells beneath the retina in one eye.

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Blind man's sight restored by stem cell treatment

Bringing a New Stem Cell Treatment to Cancer Patients: Dr. Karen Aboody, M.D. at TEDxAJU – Video

Bringing a New Stem Cell Treatment to Cancer Patients: Dr. Karen Aboody, M.D. at TEDxAJU
Dr. Aboody is an Associate Professor both in the Department of Neurosciences and Division of Neurosurgery at City of Hope. Her research focuses on using stem...

By: TEDxTalks

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Bringing a New Stem Cell Treatment to Cancer Patients: Dr. Karen Aboody, M.D. at TEDxAJU - Video

Sports Medicine New Frontiers: Platelet-Rich-Plasma (PRP) and Stem Cell Therapy

CLEARWATER, Fla., May 20, 2013 /PRNewswire/ -- Sports Medicine is always at the forefront of innovative medical technology. Athletes are constantly striving to improve. Records are broken as humans run faster, jump higher, and strive for higher levels of performance. Athletes expose their bodies to more wear and tear as performance increases. Scientific training principles and diet have changed drastically over time. Technological breakthroughs have also impacted the rehabilitation process. The use of regenerative medicine has grown significantly in recent years. The popularity of Platelet-Rich-Plasma (PRP) has escalated as many high profile elite athletes from a diverse array of sports have opted for this treatment. The likes of Kobe Bryant, Rafael Nadal, and Tiger Woods garner ample press coverage when they are treated for injuries. Stem Cell Therapy becomes headlines when Peyton Manning undergoes this treatment. The goal of regenerative medicine therapies is to aid the body to heal itself. Understanding and accepting stem cell therapies for athletic injuries and sports medicine is gathering keen interest.

Dr. Dennis Lox, http://www.drlox.com a Sports and Regenerative Medicine Physician in the Tampa Bay Florida area, comments that the scientific backdrop of cell signaling and inflammatory mediators has led to a new understanding of how tissues heal. This also explains why injured tissues fail to heal, and is why the aging athlete recovers and heals more slowly than his younger counterpart. It is felt that the use of growth factors in Platelet-Rich-Plasma (PRP) is a localized cellular response to control negative repair processes and direct healing toward a positive restorative pathway. This directional approach to control repair, is more complex in stem cells, and as such, may be more effective for healing injured tissue. The stem cells are the body's repair cells that direct the necessary patterns of cellular messenger signals to target the repair process. It is not a simple chemical reaction where two chemicals react and one outcome results. There are a myriad of complicated molecules that interact to direct the repair process, and to counter the effects of a multitude of other molecules and signals regulating the breakdown or degradation of tissue. Dr. Lox points out, it is overcoming the many undesirable messages that occur with injury, whereby regenerative medicine may enhance sports injury recovery. Athletes are in need of rapid recovery to avoid losing peak conditioning. Aging athletes do not heal as effectively. Finding successful measures to aid the body in the healing naturally, is desirable for athletes and in preventing degenerative arthritis. Understanding the scientific rationale for the use of Platelet-Rich-Plasma (PRP) and Stem Cell Therapy, may pave the way for the expansive role for these treatments in future directions for athletic injury.

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 New Frontiers: Platelet-Rich-Plasma (PRP) and Stem Cell Therapy