September 13-14, 2013
Cebu City Sports Club
In the last few months, proponents of stem cell therapy have issued statements to the media regarding the supposed efficacy of this approach for diabetes mellitus with claims that it can normalize blood sugars within 2 months or at least decrease the number of anti-diabetic medications.
The Philippine Society of Endocrinology and Metabolism (PSEM) would like to warn the public that there is NO cure for diabetes mellitus and that at the moment stem cell therapy is an experimental treatment for both Type 1 and Type 2 diabetes. There is as yet, no conclusive evidence that stem cell therapy is effective and safe for diabetes.
As such, stem cell therapy cannot be made available to individuals with diabetes, as a standard treatment like the usual drug prescriptions but rather, any patient who is receiving stem cell therapy for diabetes should receive it only under controlled conditions such as under experimental protocols of clinical trials. Patients receiving stem cell therapy under clinical trials should NOT pay for these experimental treatments and must sign an informed consent that explains the procedure, its benefits and possible harms. All clinical trials also need to be registered with and approved by the Food and Drug Administration (FDA) before implementation.
While it is true that stem cell therapy is labeled as promising in many reviews of its use in both Type 1 and Type 2 diabetes, it is still a science that is in in its infancy and much is not yet known about its use. Like many emerging therapies, “side effects and long-term safety must be determined, since transplanted cells may remain for many years in patients’ bodies. Therefore, careful monitoring and extended follow-up of patients who receive stem cell treatments is extremely important.” [www.isscr.org- International Society for Stem Cell Research (ISSCR) Patient Handbook].
We therefore, urge the public to refrain from availing of stem cells for the therapy of diabetes. Its use in diabetes mellitus can only be justified by research in the setting of clinical trials. Any patient who is being offered this form of therapy for diabetes should first ensure that a specialist in the treatment of diabetes is seeing them and that they are in fact being enrolled in a clinical trial. They should also verify with the FDA if such a trial is registered and approved by this agency.
Please report to the FDA any of the following:
1. Use of stem cell therapy by persons or institutions not accredited by FDA;
2. Use of stem cell therapy for diabetes mellitus outside of a clinical trial or as actual treatment;
3. Acceptance of payment for stem cell therapy when used for diabetes mellitus
Please report the above to (02) 9102253 or the FDA website: firstname.lastname@example.org
The grants will be awarded to researches conducted by:
Deadline for submission of research protocols is on October 15, 2013
For further details please contact the PSEM secretariat.
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