MANILA, (PNA) — The coalition of doctors, members of the academe and health groups are disappointed by the weak government regulation on stem cell therapy, which can pose serious risks to unknowing patients.
The members of PCP Advocacy Committee criticize the newly-released FDA Circular No. 2013-020, that states the initial three standards of health care generally recognized by the FDA, which are hematopoietic stem cell transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells.
“The identified standard is too general,” said Dr. Maricar Limpin, PCP Chair of the Advocacy Committee, adding that, “FDA should provide more specific conditions where stem cell based therapy is proven safe and effective.”
The “No to Scam Stem Cell Therapy Coalition” is contesting that hematopoietic stem cell transplantation can be misleading because it failed to specify the ailments or indications where stem cell therapy is proven safe and effective.
The recent guidelines released by Food and Drug Administration (FDA) fell short and will not stop the proliferation of stem cell therapy for ailments that were not subjected to scientific study or clinical trials, according to Dr. Limpin.
In the US, where the regulation of stem cell therapy is stringent, hematopoietic stem cell transplantation is specified as blood and bone marrow transplantation for Leukemia, Lymphomas, Anemia and Selected Tumors.
The doctors call for the government’s stringent regulation on stem cell therapy in order to protect the public from using stem cell therapy for treatments that are not subjected to experimental or clinical trial.
It is the responsibility of the government to inform the public that the effectiveness and safety of stem cell therapy are still unproven in heart, lung, neurologic, skin, rheumatologic, kidney and gastrointestinal disease, diabetes mellitus, hypertension, autism, cancer, aging and aesthetics, HIV, AIDS, and other conditions. We stand by our position that stem cell therapy can only be proven safe and effective for its intended purposes throught science and evidence-based medicine.” Limpin, explained.