APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an “Off-the-Shelf” Allogeneic Stem Cell Product for the…

By Dr. Matthew Watson

Fremont, CA , Oct. 28, 2020 (GLOBE NEWSWIRE) -- APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT). The meeting, which included CBER OTAT staff together with the APstem team, focused on the development plan for AP-Skin-01, a novel “off-the-shelf” allogeneic stem cell product derived from adult pluripotent stem cells (APSCs™) for the initial treatment of diabetic ulcers.

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APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an “Off-the-Shelf” Allogeneic Stem Cell Product for the...

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