UPDATE on Stem Cell Therapy

7 November 2012

The Department of Health (DOH) saw the necessity to cover regulations for Stem Cell therapy. Stem Cell therapy belongs to the category of Advanced Cell therapy which includes biologics and blood. Many countries around the world apply a risk-based approach to assess the quality, efficacy and safety of advanced cell therapy. In many countries, Stem Cell is considered an investigational intervention.

Stem Cell research employs both autologous (from same person) or allogenic (from another organism like animal or another human cell or tissue sample) method. Because there are many steps in the preparation of this lab and invasive procedure, there is therefore need to have a regulatory framework to protect Filipino citizens.

Important questions were asked: is there proof of concept in animal trials where stem cell can then be applied in humans? Is there a way to ensure quality and purity of the raw materials? How safe is the procedure? How many did not benefit from the procedure? If this were investigational procedure, how will human subjects be protected?

Sec. Enrique Ona convened a consultative working task force to provide recommendations on how to proceed in the early part of the year in response to queries and mushrooming of centers here and overseas. This led to the creation of a regulatory task force to oversee the appropriate steps that will ensure quality, efficacy and safety documentation of this intervention.

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UPDATE on Stem Cell Therapy 7 November 2012