MANILA, Philippines (UPDATED) – Rappler talked to Department of Health (DOH) Secretary Enrique Ona and Food and Drug Administration (FDA) Director Kenneth Hartigan-Go to clarify the government’s stance on stem cell therapy.
Stem cell therapy or regenerative medicine is a medical intervention that uses the body’s repair cells to substitute old cells. It is done for medical and aesthetic purposes that are still being “investigated,” according to the health secretary.
Asked why the treatment was allowed in the market despite no definitive curative and preventive benefits, FDA’s Hartigan-Go said authorities never allowed the treatment to begin with.
“It’s just there. Now, the DOH under Secretary Ona’s leadership took action,” he said. (READ: DOH: Stem cell therapy not yet proven to be curative)
On March 18, the DOH issued the rules and regulations for the accreditation of health facilities engaging in human stem cell and cell-based or cellular therapies in the Philippines.
The FDA has also released a circular on Monday, July 8, regarding the guidelines on registering stem cell-based products. The circular covers all products with a “claim, label, or poster” that says stem cells. (READ: FDA Circular: Registration of Stem Cell-Based Products)
Below are 6 things the public needs to know about the procedure:
1. The curative and preventive benefits of stem cell therapy are still under investigation.
Secretary Ona says patients must be made aware when they undergo the stem cell therapy that they are part of a treatment still being investigated by the DOH in terms of preventive and curative benefits.
2. Stem cell products are injectible.
Wary about reports that a number of stem cell products available in the market are in “tablet” and “lotion” form, Hartigan-Go warns that all stem cell products are injectible.
3. There is no such thing as a plant stem cell.
Plants have stems but not stem cells. Doctors who say they source stem cells from plants are most likely duping their patients.
4. Lack of effect is a form of adverse effect.
“You promised that this is going to work, and it has no effect. So therapeutic failure is a form of adverse effect,” Hartigan-Go explains.
Physicians who promise cure and fail to deliver should be reported to the authorities, specifically the Professional Regulatory Commission.
5. Treatments can only be conducted in accredited facilities.
Be wary of procedures being proposed to be done at hotels. Stem cell therapies should be performed in health facilities accredited by the DOH. These facilities comprise mainly of hospitals.Non-hospital-based facilities should be linked through a contractual agreement with a hospital licensed by the DOH.
6. The DOH intends to regulate the conduct of stem cell therapy in the country using 6 principles, which patients can also use to guide them in their decision-making:
- Professional (if the medical doctor is qualified to perform the treatment).
- Place (if the procedure will be conducted in an accredited hospital with the proper facilities).
- Process (if the necessary laboratory testing is conducted and sterility and proper temperature control are maintained).
- Product (if the injectible stem cell product has been registered with the FDA).
- Publicity (if the practitioner’s claims match and are validated by scientific proofs).
- Population (if there has been substantial recorded data of patients who have benefited from the procedure in a span of a year).
The DOH encourages the development of the science of stem cell therapy, as it has the potential to provide “tremendous” medical benefits. It urges practicing stem cell transplant physicians to submit data regarding the conduct and results of the treatments they have done. – Rappler.com