Keynote Message of Secretary Enrique T. Ona
Philippine Society for Stem Cell Medicine
1st National Convention “The Truth and Fallacies about Stem Cell Therapy”
January 16, 2013, Pandanggo Hall, Manila Hotel
The establishment of the Philippine Society for Stem Cell Medicine composed of physicians with interest in stem cell therapy is opportune, with the increasing demand for the use of stem cells as therapy in oncology, end organ diseases and regenerative medicine, here now in the Philippines and worldwide. I congratulate the founding members, led by Dr. Jose Sabili, your Chairman and Dr Rey Melchor Santos, your President for recognizing the need to organize and professionalize the practice of stem cell therapy in this country.
This two-day national convention, with the theme “The Truth and Fallacies about Stem Cell Therapy” is very timely as we in the Department of Health and the medical profession try to clear the air of misinformation and half-truths regarding this popular mode of treatment. We owe it to our patients and the general public to ensure that proper information and guidance regarding this novel medical approach is available. To protect themselves and their loved ones, the public must know the most current and accurate information about stem cells and its various applications, including some of which are purely experimental. We must ensure that only safe and ethical uses of stem cells are being used in the Philippines.
Today, we see the proliferation of “centers” offering stem cell treatments for medical and aesthetic purposes. Some stem cell programs here have expert personnel and clinical facilities and advanced laboratory equipment and technologies, reputed to be more advanced than other institutions abroad. We are concerned, however, that other facilities might not have the minimum capabilities especially trained personnel staff and equipment needed to perform stem cell therapies safely and effectively.
Although this technology holds promise, stem cell therapy is not yet part of standard of care and is considered an investigative procedure for compassionate use. Applications of stem cells for the treatment of malignancies, blood disorders, degenerative diseases (e.g., Alzheimer’s Disease), metabolic diseases (e.g., diabetes), and immune cell therapy are still under clinical evaluation and study.
We know today that the safest and most effective cellular preparations are those that use the patients’ own cells – called autologous human cells. Thousands of patients worldwide have been treated over several decades with autologous human cells and their safety and efficacy is well established especially those derived from the bone marrow and peripheral blood. Umbilical cord stem cells also have a long track record of safety and efficacy.
However, there are other stem cell preparations that still need strict regulatory assessment and will be allowed for human use in the Philippines purely on an experimental basis. Our patients must be made aware of this status. In the meantime, the public must avoid receiving cell preparations that are being offered in the Philippines and elsewhere, such as embryonic, aborted fetal, genetically altered and animal stem cells.
The Department of Health has the responsibility and authority to regulate these cell treatments for human use and to provide information and guidance to the general public. After consulting with various stakeholders, including academics, stem cell practitioners and researchers, we will be soon releasing the Rules and Regulations Governing the Accreditation of Health Facilities Utilizing Human Stem Cell Preparations and Cell-Based or Cellular Therapies in the Philippines. These guidelines seek to, among others, ensure a minimum quality of service and staff qualification rendered by hospitals and other health facilities capable of utilizing human stem cell preparations and cell-based therapies; and guarantee that human stem cell preparations and cell-based therapies in the Philippines are safe and effective for their intended use.
These guidelines will classify which stem cell preparations and therapies will be registered and allowed, restricted and prohibited. Health facilities utilizing stem cell preparations and cell-based or cellular therapies will be mandated to comply with the guidelines set by the Bioethics Advisory Board to be established by the DOH. This Board will ensure that ethical and professional standards are upheld and that contentious scientific, ethical and legal issues are addressed. Meanwhile, an Institutional Review Board will review and approve stem cell therapies, based on the guidelines set by the Bioethics Advisory Board. There are minimum standards for personnel qualifications, physical facilities, equipment and supplies and work environment which will be prescribed by the guidelines. Proper record keeping in each facility that will provide readily available information on each donor, patient, procedures on stem cell and cell-based therapies will be mandated as well.
Our efforts at regulating the practice of stem cell therapy in this country is aimed at safeguarding the welfare of our patients and the general public by making safe, effective and ethical stem cell modalities and practices are within emerging international and global standards considering the very complex nature of this thepary.