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(NAR) VOL. 25 NO. 3 / JULY - SEPTEMBER 2014
[ FDA CIRCULAR NO. 2014-013, May 21, 2014 ]
RE-ASSESSMENT OF THE APPLICATION OF STEM CELL THERAPY FOR CORNEAL RESURFACING WITH LIMBAL STEM CELLS
Adopted: 21 May 2014
Date Filed: 01 July 2014
The Department of Health (DOH) issued Administrative Order No. 2013-0012 with the objectives of protecting the public and assuring the safety of patients by setting standards for health facilities that offer stem cell therapy. Likewise, the Food and Drug Administration (FDA), issued FDA Circular No. 2013-017 for the purpose of regulating stem cells, cellular or tissue products and ensure that these health products meet the standards of safety, efficacy and quality.
The FDA Recognizes the following applications of stem cell therapy as apart of the standard health care treatment; (1) Hematopoietic stem cell transplantation; (2) corneal resurfacing with limbal stem cells; and (3) skin regeneration with epidermal stem cell, as cited in FDA Circular No. 2013-020.
In the light of commitment of FDA to fulfill its mandate, the Center for Drug Regulation and Research in the process of re-assessing the application of stem cell therapy for corneal resurfacing with limbal stem cells. All stem cell practitioner, clinicians or researchers are hereby requested to report or share their experience, both successful and failure, on the use of corneal resurfacing with limbal stem cells.
All reports or information may be submitted to the FDA Public Assistance, Information and Receiving (PAIR) Unit, Alabang, Muntinlupa City from Monday to Friday at 8:00 to 5:00 pm or e-mail: rsobligacion@fda.gov.ph.
(SGD) KENNETH Y. HARTIGAN-GO, MD
Acting Director General