Stem Cell News

BioInformant's coverage of stem cell news includes iPS cells, mesenchymal stem cells, hematopoietic stem cells, neural stem cells and more.

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PolarityTE Announces FDA RMAT Awarded to Its Designation Granted to SkinTE®

May 16, 2022 By Cade Hildreth, Founder & President 1 Comment

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…]

denovoMATRIX Launches Novel Microcarrier to Advance Cell and Gene Therapy Manufacturing

May 4, 2022 By Cade Hildreth, Founder & President Leave a Comment

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.

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Ncardia Launches Cellistic™, the Only iPSC-based Cell Therapy Process Development & Manufacturing Partner Purpose-built to Make Large-scale Allogeneic Cell Therapy Production a Reality Today

April 26, 2022 By Cade Hildreth, Founder & President Leave a Comment

GOSSELIES, Belgium, April 19, 2022 – Ncardia has launched a new business, Cellistic™, to focus Ncardia’s induced pluripotent stem cell (iPSC) expertise on the cell therapy development and manufacturing sector. This strategy expands on Ncardia’s existing drug discovery solutions business and capitalizes on the company’s deep expertise in iPSC differentiation and expansion to focus dedicated resources and capabilities to address the growing need for iPSC cell therapy solutions, including the development of robust cell-specific manufacturing platforms. [Read more…]

ShiftBio Partners with RoosterBio to Accelerate Development of a Novel Genetically Engineered Exosome, SBI-102 for Rare Diseases and Cancer

April 26, 2022 By Cade Hildreth, Founder & President Leave a Comment

RoosterBio’s MSC-derived exosome bioprocess technology platform enables accelerated development of ShiftBio’s lead therapeutic candidate via a scalable cGMP manufacturing process in bioreactors, downstream purification, and analytical characterization.

Seoul, South Korea and Frederick, MD, April 26, 2022 – ShiftBio, a leader in the development of innovative exosome platform technologies, announced today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. This partnership will accelerate ShiftBio’s therapeutic candidates, starting with SBI-102 (Stem cell-derived exosomes expressing a therapeutic ligand), into the clinic. [Read more…]

FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial

April 25, 2022 By Cade Hildreth, Founder & President Leave a Comment

AUSTIN, Texas, April 21, 2022 – Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV company to receive FDA Phase 3 approval for an Investigational New Drug (IND) indication to date.
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