On September 4, 2019, Magenta Therapeutics announced it had received an FDA Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, an expanded CD34+ cell therapy treatment used in place of single umbilical cord blood (UCB) transplantation. This one-time stem cell treatment is being investigated for the treatment of multiple inherited metabolic disorders. While there are 36 publicly announced RMAT designations, the FDA states that 40 or more have been awarded to date. [Read more…]
RoosterBio Launches the Only Umbilical Cord hMSC System in the World Designed for Perinatal Cell Therapy Product Development
RoosterBio, Inc, a biotechnology market disrupter and leading supplier of innovative human mesenchymal stem/stromal cell (hMSC) biomanufacturing systems, released the Regenerative Medicine industry’s first human umbilical cord (hUC) MSC paired cell and media system designed for product development and bringing with it an unprecedented step-change in quantifiable productivity metrics. RoosterVial™-hUC-MSC-XF, allows scientists to generate billions of perinatal cells in a fraction of the time when paired with RoosterBio’s existing xeno-free (XF) hMSC plug and play systems. This product line is the only commercially available, high-volume perinatal MSC bioprocess system with a line of sight to towards clinical translation. [Read more…]
SanBio Awarded RMAT for SB623, a Modified Stem Cell Treatment for TBI
SanBio, a company developing regenerative cell medicines for neurological disorders, has been awarded a regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for SB623.
SB623 is a cell therapy that the company has developed for the treatment of chronic neurological motor deficits that occur as a result of traumatic brain injury (TBI). In addition to this treatment, SanBio is developing regenerative therapies for stroke, diseases of the eye, Parkinson’s disease (PD), and other neurological conditions. [Read more…]
Propagenix – Interview with the President and CEO, Brian Pollok, Ph.D.
Propagenix is a preclinical-stage platform technology company that is applying its unique technology to both internal and partnered cell therapy programs. The company is engaged in the development and commercialization of technology which originated from the laboratory of Dr. Richard Schlegel of Georgetown University.
PLEXOVAL Exosome Wound Healing Human Study Starts
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A world-first study using cell free exosome product manufactured using Exopharm’s LEAP Technology
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Study sites at the Royal Melbourne Hospital and Australian Red Cross Blood Service
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Results by mid 2020
26 August 2019, Melbourne, Australia: Regenerative medicine company Exopharm Limited (ASX:EX1) announces the start of the PLEXOVAL Phase 1 study, the first human clinical trial using exosomes for wound healing. [Read more…]
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