SALT LAKE CITY, May 13, 2022 –PolarityTE, Inc. (Nasdaq: PTE) today announced that the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company’s open IND. [Read more…]
Stem Cell News
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What Is An RMAT? List of Publicly Announced RMAT Designations (64)
To date, 64 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 187 requests and issued 70, which means that a handful are not yet public knowledge.
Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
Thus far, AlloVir is the only company to receive three RMATs, while 5 companies (Abeona Therapeutics, Athersys, CARsgen Therapeutics, Rocket Pharmaceuticals, and CRISPR Therapeutics) have received two RMAT designations from the U.S. FDA.
denovoMATRIX Launches Novel Microcarrier to Advance Cell and Gene Therapy Manufacturing
DRESDEN, Germany, May. 04, 2022 — denovoMATRIX GmbH, an innovator in cell and gene therapy (CGT) manufacturing, announced the launch of a novel microcarrier for increasing access to high-quality mesenchymal stromal cells (MSCs) for stem cell-based therapies. The product, termed beadMATRIX, is designed to enable MSC proliferation and harvest in xeno-/serum-free media with high efficiency and stemness.
Distinguished Physician, Dr. Warren J. Bleiweiss, Fellow of the AASCP, Will Present at the AASCP Conference on June 17-19, 2022
American Academy of Stem Cell Physicians will host expert speakers from across the country lecturing on recent innovations in stem cell research on June 17-19, 2022, in Miami, Florida.
“The Academy is proud to offer state-of-the-art Regenerative Medicine workshops this June, which will be lead by experts with over 100 years of combined experience,” said Dr. Sunny Kim, President of the AASCP. [Read more…]
Interview with Uri Lee, CEO of Xcell Therapeutics
This is an interview with Uri Lee, CEO of Xcell Therapeutics. Xcell is an international leader in serum-free, chemically defined media. In this interview, we discuss the mission and purpose of Xcell Therapeutics, its product development pipeline, its rapid growth, and the company’s future goals. Enjoy. [Read more…]
