Six PHL hospitals administering non-FDA-approved stem cell therapies, doctors' group claims

By EARL VICTOR ROSERO, GMA News

Published September 24, 2013 5:30pm

The Philippine College of Physicians urged several hospitals and medical practitioners to adhere to established standards of practice and medical ethics when they perform stem cell therapies (SCT) after they learned that there have been deviations from the three approved uses of stem cells in the country.

PCP officials appealed to the Philippines's Food and Drug Administration (FDA) and Professional Regulation Commission on Tuesday to strictly enforce “standards of practice” involving stem cell cures and probe advertised SCT techniques, adding that the only recognized SCT as of now are:

hematopoietic stem cell transplantation;
corneal resurfacing with limbal stem cells; and
skin regeneration with epidermal stem cells.

The PCP said all other SCT done in some hospitals and by some doctors that are not FDA-approved and are “off-label”, including those purported to address diabetes, autism, and HIV-AIDS must meet rigorous clinical standards and peer review.

Hematopoietic stem cell transplantation for specific cancers involves the bone marrow, corneal resurfacing with limbal stem cells concerns the eyes, while skin regeneration with epidermal stem cells is used to treat severe burn cases.

Dr. Carlos Lasa, a plastic surgeon, said the cosmetic and aesthetic applications of stem cell techniques have been “abused” and advised that people who are considering stem cell methods to heed the advice of doctors who adhere to FDA-approved methods.

Internist-cardiologist Dr. Antonio Leachon said the St. Luke's Medical Center has assured them that SLMC will only administer FDA-approved SCT and conduct clinical trials, but the PCP is concerned about some hospitals known to be administering non-FDA-approved stem cell therapies according to media reports and advertisements.

Using a Powerpoint presentation, Dr. Leachon identified the hospitals of concern to them:

The Medical City (Institute of Personalized Molecular Medicine) in Pasig City;

The National Kidney & Transplant Institute (NKTI);

Makati Medical Center;

Adventist Hospital in Cebu;

St. Paul's Hospital in Iloilo; and

St. Paul's Hospital in Tarlac.

Leachon also said there are various clinics engaged in non-FDA-approved SCT.

Dr. Maricar Limpin said informed consent of SCT patients should be done according to professional standards and by adequately informing patients of "both the benefits and risks" of the techniques being presented.

Limpin, the PCP advocacy committee chairperson, also said the PHL FDA's new guidelines which took effect last September 1 “failed to specify” the ailments for which the approved stem cell therapies would be effective.

The PCP officials said they are awaiting action from the PRC Board of Medicine, which, they have learned, has arrived at a decision about their concerns.

They also seek another dialogue with the FDA and Health Secretary Enrique Ona.

The doctors' group is also poised to seek an ethics opinion from the Catholic Bishops Conference of the Philippines.

For her part, Dr. Ma. Bernadette Manalo-Arcena of the Philippine Psychiatric Association said as far as they know, there are no approved stem cell therapies yet for autism.

The PCP officials said stem cell therapies done for innovation and compassionate reasons must be administered according to clinical trial standards and with full disclosure of all results in a peer-reviewed system.

They also urged Congress to adequately fund the FDA so that it will be able to develop the expertise and competence to evaluate stem cell therapies done in hospitals and other medical facilities in the country.

SCT regulation overseas

Stem cells are the body's master cells and are able to differentiate into all other types of cells. Scientists say that by helping to regenerate tissue, they could offer new ways of treating diseases for which there are currently no treatments - including heart disease, Parkinson's and stroke.

There are two main types of stem cells - embryonic stem cells, harvested from embryos, and adult or iPS cells, cells taken from skin or blood and reprogrammed back into stem cells.

In the United States, the FDA there said it "has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system."

The Mayo Clinic, a US-based research-oriented medical care clinic said on its website: "The promise of stem cells is huge, but for now, most applications are still in their infancy. Many questions remain about how to guide the behavior of implanted stem cells inside the body. Researchers are unsure if stem cells will survive, cause tumors or possibly become some type of unintended cell. Most research remains confined to the laboratory as scientists seek to learn more."

In Europe, (t)here are no concerns with haematopoietic (blood) stem cells that are used for transplantation to restore bone marrow function, according to the European Medicines Agency.

"These are not considered to be medicinal products," the EMA added.

The EMA clarified that "to date, no stem-cell medicinal products have received marketing authorisation within the European Union (EU)."

"However, it is still possible to gain access to stem-cell medicinal products under certain controlled conditions," the EMA said. "These include taking part in clinical trials or compassionate-use programmes, or receiving a custom-made medicine as part of ‘hospital exemption’."

Chris Mason, a professor of regenerative medicine at University College London, said he had no doubt that being able to reprogram cells in the body to different cell types would be useful in producing future therapies capable of transforming patients' lives, but said there are many more years of research ahead before that would be possible. — with Reuters/TJD/ELR, GMA News

Tags: stemcelltherapy, philippinecollegeofphysicians, foodanddrugadministration