Stem cell therapy or regenerative medicine is a promising new treatment that introduces new adult stem cells onto the damaged tissue that is said to help combat injury or disease, or repair old, damaged cells.
Well-heeled personalities and politicians are reported to have received the benefits of its treatment. Names like Gloria Macapagal Arroyo, Juan Ponce Enrile, and former President Erap Estrada are said to have been injected with this cure-all that supposedly makes them more sprightly, healthier, and feel younger beyond their years.
However, some practitioners are said to be unlicensed and thus, unauthorized to provide such treatment. To regulate stem cell treatment in the country, the Department of Health (DOH) issued guidelines on registering stem-based products.
Here’s what you should know about the procedure.
1. Only 3 stem cell procedures are allowed in the Philippines.
The Food and Drug Administration (FDA) rejected the registration of other stem cell products, and other therapies are considered illegal.
According to FDA director general Kenneth Hartigan-Go, only the following is allowed: the use of stem cells in “hematopoietic transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells”. Those 3 are recognized by the FDA as “acceptable or standard healthcare procedures.”
“Those who want to do stem cell outside of the three approved indications will have to register, either for compassionate use or clinical trial (as) these are the ones we inspect,” he added.
2. All cellular or human tissue-based products must be registered.
Based on a FDA Circular 2012-017, all hospitals and other health care facilities that provide stem cell therapies should be registered all human cells, tissue and other cellular and tissue-based products. Those that fail to apply for accreditation shall be considered “unapproved and unauthorized for use.”
3. All stem cell products are injected.
According to Hartigan-Go, stem cell products are injectible; these don’t exist in tablet or lotion form.
4. There is no such thing as “plant stem cells”.
Products that are used for stem cell therapy are not plant-derived. Plants have stems, but not stem cells that are used for stem cell therapy. Medical practitioners who claim this are most likely duping their patients.
5. All treatments should be conducted in accredited facilities.
Stem cell therapies should be done inside health facilities that are duly accredited by the Department of Health (DOH), which are mostly hospitals. Non-hospital facilities should have a contractual agreement with a DOH licensed hospital.
6. The DOH intends to use these 6 Principles for regulating stem cell therapy.
Professional: Is the doctor qualified to do the treatment?
Place: Is the procedure done in an accredited hospitals?
Process: Is testing regularly conducted? Are facilities and equipment sterile? Do they maintain proper temperature control?
Product: Is the injectible product registered with the FDA?
Publicity: Is the practitioner’s claims validated by scientific proof?
Population: Is there enough substantial recorded data of patients who report positive benefits?
7. Stem cell therapy is still being investigated.
DOH Secretary Enrique Ona says that the public should be aware that when a patient chooses to undergo stem cell therapy, the preventive and curative benefits of their treatment is still being investigated by the DOH.
However, the DOH acknowledges that the science of stem cell therapy has the potential to provide tremendous medical benefits, and as such, encourages licensed practitioners who administer this treatment to submit data as regards the results of their therapy.