DOH sets deadline for stem cell therapy accreditation

Manila, Philippines -- Hospitals and health facilities offering stem cell therapy have until August 31 to apply for accreditation from the Department of Health (DoH).

DoH Secretary Enrique T. Ona said a number of hospitals in Metro Manila have already applied for accreditation to perform this "innovative" treatment that has not yet been accepted as standard mode of care in the country since it needs further tests and several more layers of research.

In the first mid-year convention of the Philippine Society for Stem Cell Medicine at the Manila Hotel yesterday, Ona reiterated that stem cell therapy is "the future of medicine."

"Stem cell therapy is not a cure-all medical treatment. Patients have yet to be presented first with standard of treatment, and in many cases, stem cell treatments have to be done in conjunction with other standard modalities of treatment," he said.

The Bureau of Health Facilities and Services (BHFS) of the DoH is accepting the applications for accreditation while a bio-ethics committee and a hospital-based review board will go over the applications and decide on their approval.

Five big hospitals in Metro Manila have already applied for accreditation, said Nick Lutero, chief of the BHFS.

Lutero said initial checks have revealed that these hospitals possess the required equipment needed for the treatment but they would still have to check on requirements set by the Food and Drug Administration (FDA) in relation to the practice.

Lutero said institutions that are offering stem cell treatments can still perform the procedures pending the approval of applications. However, once formal accreditations are already given, unaccredited institutions should cease offering stem cell therapy.

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DOH sets deadline for stem cell therapy accreditation

Medical groups get support over bid for free stem cell

TWENTY-TWO medical organizations pushing for the free stem cell treatment in the country on Tuesday got a shot in the arm as the co-chairperson of the Philippine Health Research Ethics Board (PHREB) expressed agreement to their position.

In a weekly forum in Quezon City, PHREB co-chairperson Dr. Marita Reyes said it is only right that the patient undergoing stem cell therapy will not be charged, especially since the amount involved is millions of pesos.

"The one who will carry the most risk should not be made to pay," opined Reyes.

Over the weekend, 22 medical organizations said that stem cell therapy should be given free based on ethical standards.

"When stem cell is given under a clinical study, it is unethical to make patients pay for the treatment. The cost of treatment should be shouldered by the sponsor of the study," said the organizations in their position paper.

However, Department of Health (DOH) Secretary Enrique Ona rejected this. Ona said, the country cannot afford to make service providers shoulder the cost of the stem cell treatment.

This was despite his admission that the government has yet to approve any type of stem cell treatment and that those practiced here can still be considered as "clinical trials."

According to Reyes, such a statement from the Health chief is just unfortunate.

"Sino ba ang may risk? Ang pasyente. Tapos siya pa ang magbabayad? Excuse me. Hindi ba medyo unjust naman yon," said Reyes.

Stem cell therapy is a type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury and has recently seen growing popularity in the country. (HDT/Sunnex)

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Medical groups get support over bid for free stem cell

Doctors hit stem cell promotion

Manila, Philippines --- The Philippine College of Physicians (PCP) yesterday appealed to politicians and celebrities who have undergone the controversial stem cell therapy to stop promoting the procedure which has become a subject of debate for local medical practitioners.

"Pakiusap ko sa kanila, huwag na kayo magpagamit kasi mas malakas pa kayo sa Billboard," Dr. Tony Dans, president of the Philippine Society of General Internal Medicine (PSGIM) said at a forum in Quezon City yesterday.

Stem cell treatment is still in its experimental stages and is therefore not yet an accepted form of treatment in the country, the PCP leaders emphasized.

The group presented a slide containing photos of public figures who had reportedly undergone stem cell therapy.

One of the photos showed Manila Mayor Joseph Estrada who earlier revealed he underwent stem cell treatment in Germany in 2012 where he received stem cells from an unborn sheep.

"Sana huwag na lang siyang (Estrada) maging 'endorser' kasi madami siyang following baka sumunod sa kanya," said Dr. Anthony Leachon, Vice President of PCP.

The Department of Health (DOH) bans the use of stem cells gathered from animal and plant sources. The sources of stem cells allowed in the Philippines is the Autologous or Adult Stem Cells taken from the patient's own blood, bone marrow and fat.

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Doctors hit stem cell promotion

Osiris Doubles on Study Showing Grafix Closes Wounds

Osiris Therapeutics Inc.s shares more than doubled after the regenerative-tissue company said a trial of its living stem cell treatment closed three times as many diabetic foot ulcers as standard care.

Osiris rose to $21.75 at 12:53 p.m. New York time, after earlier reaching $24.78 for the biggest intraday gain since the company first sold shares to public in August 2006.

Interim results from 97 patients in the study found 62 percent of those on Osiriss Grafix had their wound completely closed compared with 21 percent who received conventional treatment, the Columbia, Maryland-based company said today in a statement. Grafix is a flexible, conforming membrane that is applied directly to wounds. The trial also found the therapy also closed wounds faster.

Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine, C. Randal Mills, chief executive officer, said in the statement. Diabetic foot ulcers afflict 25 percent of all diabetics and are responsible for more hospitalizations than any other diabetic complication.

The trial is discontinuing the blind phase of the study where its not revealed which patients are receiving which treatment. Patients who were receiving the standard of care will be offered treatment with Grafix, Osiris said.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Osiris Doubles on Study Showing Grafix Closes Wounds

Bill filed to regulate stem cell therapy in PH

By Christian V. Esguerra Philippine Daily Inquirer

La Union Rep. Eufranio Eriguel. Photo from congress.gov.ph

MANILA, PhilippinesA congressman has joined the call to regulate stem cell therapy administered in the country.

La Union Rep. Eufranio Eriguel has introduced House Bill No. 212, which would put up a bioethics advisory board that would establish ethical standards governing the practice of stem cell research and therapy.

Under the proposed Stem Cell Research and Therapy Act of 2013, the board shall be responsible for addressing contentious ethical, scientific and legal issues in stem cell and cell-based or cellular research and therapies.

There is much to be learned from stem cell therapy, its benefits and application in the cure of some of the most devastating diseases and conditions. As of now, the full promise of stem cell treatment remains unknown, Eriguel said in a statement.

But the cost far outweighs its benefits because it is very expensive and only a few physicians are trained to do stem cell procedures here in the Philippines.

In his proposal, the board will be headed by the health secretary and the National Transplant Ethics Committee, while the Food and Drug Administration director will serve as vice chairman.

A proposed institutional review committee will be tasked to approve stem cell and cell-based or cellular research and therapies based on existing Department of Health guidelines.

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Bill filed to regulate stem cell therapy in PH

Grafix® Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), reported today that its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p

The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.

Today, Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine, said C. Randal Mills, Ph.D., Chief Executive Officer. Diabetic foot ulcers afflict 25% of all diabetics and are responsible for more hospitalizations than any other diabetic complication. With 25 million diabetics in the United States, the cost to our health care system is enormous. Through this rigorous study we have shown that Grafix can heal more patients, in less time, and with fewer complications.

Top-Line Data from the Interim Analysis of Protocol 302

(n=50)

(n=47)

These data are very compelling as we have not had a new cellular therapy for diabetic foot ulcers in over 10 years, said Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery, University of Texas Southwestern Medical Center. Compared to other similarly designed studies, this trial demonstrates, by far, the largest relative improvement in complete wound closure. This is great news for our patients with diabetic foot ulcers that are at such high risk of losing their legs.

Grafix is a human cellular repair matrix that provides a high-quality source of living mesenchymal stem cells (MSCs). It is a flexible, conforming membrane that is applied directly to acute and chronic wounds.

We know now that an unfortunate consequence of diabetes is the pathological change that occurs with the number and functionality of certain stem cell populations necessary for optimal wound repair, said Michelle LeRoux Williams, Ph.D., Chief Scientific Officer. With Grafix, we are able to help correct this problem by providing patients with a rich source of healthy, non-controversial stem cells contained within a biologic matrix for easy delivery in the out-patient setting.

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Grafix® Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers

Editorial: Philippine Society for Stem Cell Medicine and Philippine Medical Association 1st Midyear Convention to be …

Two organizations of Filipino medical practitioners - the Philippine Medical Association (PMA) and the Philippine Society for Stem Cell Medicine (PSSCM) - are partnering to come up with ideas to help professionalize and organize the practice of stem cell therapy in the Philippines during their 1st Midyear Convention at the Historic Landmark Manila Hotel on August 12-13, 2013.

With the theme ''Current Status of the Practice of Stem Cell Therapy in the Philippines,'' the convention is expected to take up various issues surrounding stem cell therapy, which, despite the controversies, is increasingly becoming popular for treatment of certain illnesses. Among the scheduled topics for discussion in the convention are Food and Drug Administration Circular on Stem Cell Products, DOH Stem Cell Guidelines, Current Trends on Stem Cell Therapy, Clinical Use of Autologous, Adipose Derived Stem Cells, Photo-Activated Platelet-Rich Plasma for Orthopedic and Rehabilitation Applications, Umbilical Cord Blood and Cord Tissue for Stem Cell Therapy, Stem Cell Therapy in the Philippines other than for Cancer Rejuvenation, and Quality Control in Cell Transplantation.

Administrative Order 2013-0012 issued by the Department of Health (DOH) rules on the practice of stem cell, cell-based therapy, and accreditation of health facilities engaging in the treatment in the Philippines. The Professional Regulation Commission Board of Medicine (PRCBOM) requires foreign doctors wishing to practice stem cell therapy in the country to get a special temporary permit, citing their education, training, and clinical experience.

The PMA, the country's premier medical organization, has 70,000 members in 118 component medical societies, eight specialty divisions, 73 specialty and subspecialty societies, and 39 affiliate societies all over the archipelago, who advocate professional advancement and promote public health. The newly founded PSSCM is composed of physicians doing stem cell therapy and transplant. It is working closely with DOH, PRCBOM, and PMA to regulate the practice of Stem Cell therapy and protect patients.

We congratulate the Philippine Medical Association, headed by its President Dr. Leo O. Olarte, and the Philippine Society for Stem Cell Medicine, led by Dr. Rey Melchor F. Santos, in their coordinative efforts to educate and inform the public on the status of stem cell treatment as a novel medical approach in the Republic of the Philippines. CONGRATULATIONS AND MABUHAY!

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Editorial: Philippine Society for Stem Cell Medicine and Philippine Medical Association 1st Midyear Convention to be ...

Stem cells to mass-produce cancer-killing treatment

Stem cells to mass-produce cancer-killing treatment

Monday, August 12, 2013

Stem cell technology can be used to mass-produce cancer-killing immune cells designed to target different kinds of tumour, scientists have shown.

By John von Radowitz

But in practice, T-cells that target and kill cancer cells while ignoring healthy cells are very rare, and progress towards immune-based cancer treatments has been limited.

The new approach provides a way to reprogramme T-cells and create large numbers of them off the shelf primed to attack specific cancers.

A small number of healthy human T-cells were first reprogrammed into malleable stem cells with embryonic properties, US scientists reported in the journal Nature Biotechnology.

These induced pluripotent stem cells were then engineered to produce a tumour-specific receptor molecule on their surfaces.

Finally, the stem cells were coaxed to reacquire their original T-cell properties while expanding to large numbers.

Each of the T-cells now had the all-important receptor that allowed it to target a particular cancer antigen or protein, in this case lymphoma.

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Stem cells to mass-produce cancer-killing treatment

Potential stem cell technology may harbour cancer cure

London, Aug 12 (ANI): Researchers have revealed that stem cell technology could lead to a faster treatment for cancer patients and reduce reliance on chemotherapy.

Dr Emma Smith, senior science information officer at Cancer Research UK, said that the new discovery would also be more effective at stopping the disease from returning back by reprogramming cancer-fighting cells, the Daily Express reported.

Smith said that the technology effectively uses the body's own immune system and harnesses its power to attack the cancer cells.

The researcher said that it specifically targets the tumour cells and leaves the healthy ones alone, which means that it comes without any of the side effects with treatments like chemotherapy, which can be harsh for patients.

It takes white blood cells and transforms them into stem cells before being reprogrammed to fight the patient's cancer.

According to study's lead researcher Dr Michel Sadelain, of the Memorial Sloan-Kettering Cancer Center in New York, the technique is very specific to the cancer cells themselves, which means fewer side effects.

Sadelain added that because they stay in the body, they are 'living drugs' and once present move around and stop recurrences.

The three-year research has been tested on mice. (ANI)

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Potential stem cell technology may harbour cancer cure

Looking for a cure with stem cells

Medical science has progressed by leaps and bounds with the advent of stem cell therapy. Stem cell is a generic cell that has the potential to become many types of specialised cells for the treatment of a wide range of diseases.

In stem cell treatment, the damaged tissues of the diseased part are replaced by new adult cells. Stem cells have the potential to divide and grow into multiple tissues and regenerate natural organs.

Stem cell therapy is the new realm of regenerative medicine for Diabetes Type 1, wound healing, Parkinson's, spinal cord injury, MI, MS, and many other terminal conditions.

Who can become a Stem Cell Therapist?

From a chief scientific officer to a lab assistant, opportunities are many for medical and non-medical students. There is a prevalent misconception that only medical professionals can become a stem cell therapist. In fact, stem cells cover a lot of ground, from molecular biology and biotechnology to cell transplantation and therapy. It means that people can come into stem cell biology from more or less any field. Candidates skilled in imaging are also eligible to become stem cells researchers or therapists.

As there is always need for more tools, an electrical engineer with knowledge of biology could also develop tools for in vitro or in vivo analysis of stem cells. But he should also have a complete understanding of cellular and molecular biology.

This emerging branch of biomedicine needs quality and trained manpower. Therefore, there is plenty of room for trained scientists.

Despite the specialisation, stem cell research requires the basics, as well. Therefore a stem cell therapist needs to have core knowledge of cellular and molecular biology understanding the lab techniques and the analytical approaches.

Multiple career option

Students have the option of pursuing courses such as M.Sc. in biotechnology, biochemistry, genetics, zoology, biophysics, microbiology and life sciences and M.Sc. regenerative. After completing the degree course, they have various options of quality check, research and development, production, clinical research, supply chain and human resources besides finance and other administrative functions.

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Looking for a cure with stem cells