Stem Cell Clinic

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

Stem-cell treatment not a cure-all, charging patients for clinical study unethical – 21 doc groups

By: Jet Villa, InterAksyon.com August 11, 2013 8:10 AM

REUTERS FILE PHOTO

InterAksyon.com The online news portal of TV5

MANILA - Twenty-one medical organizations have already signed a position statement, calling for stricter regulations of stem cell products and physicians doing the transplant.

These are the: Philippine College of Physicians, Philippine College of Geriatric Medicine, Philippine Society of Allergy, Asthma and Immunology, Philippine Society of Hematology and Blood Transfusion, Philippine Society of Nephrology, Philippine Neurological Society,

Philippine Society of General Surgeons, Philippine College of Surgeons, Philippine Heart Association, Philippine Society of Endocrinology and Metabolism, Philippine Society of Medical Oncology, Diabetes Philippines, Philippine Society of General Medicine, Philippine Society for Vascular Surgery,

Philippine College of Chest Physicians, Philippine Rheumatology Association, Philippine Society of Gastroenterology, Philippine Society for Microbiology and Infectious Diseases, Philippine Academy of Rehabilitation Medicine, Philippine Society of Nuclear Medicine, and Academy of Filipino Neurosurgeons.

The groups have called on the Department of Health and the Food and Drug Administration to issue clearer regulations for stem cell therapy for practicing clinicians to safeguard the health of Filipinos.

Stem cell therapy for unproven indications is proliferating in the Philippines and posing serious safety issues to unknowing clients, they said.

(We are) alarmed by these uncontrolled practices which may include false claims, misinformation, and exorbitant fees, the added.

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Stem-cell treatment not a cure-all, charging patients for clinical study unethical - 21 doc groups

$384,000 Stem Cell Burger Grown In a Lab! – Video

$384,000 Stem Cell Burger Grown In a Lab!
Scientists have grown a stem cell burger in a laboratory, but what does this mean for science and global hunger? We look at the story with Lissette Padilla a...

By: TheLipTV

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$384,000 Stem Cell Burger Grown In a Lab! - Video