SAN DIEGO, Calif. – September 30, 2019 – Results from a study sponsored by Stemedica Cell Technologies, Inc., a global biotechnology company that uses allogeneic stem cells for ischemic conditions, form the basis for a peer-reviewed paper published in Stroke entitled “Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke.” Co-authors include Michael L. Levy, MD, PhD, John R. Crawford, MD, Nabil Dib, MD, Lev Verkh, PhD, Nikolai Tankovich, MD, PhD and Steven C. Cramer, MD. [Read more…]
Anemocyte to expand its plasmid manufacturing capabilities
A new state-of-the-art facility dedicated to plasmid manufacturing is now operational in Gerenzano, Italy. The new site will couple with the existing GMP facility active in the Cell and Gene (C&G) therapy space. With 800m2 (8,000 square feet) of cleanrooms, the two facilities of Anemocyte, the first Biotech Manufacturing Organisation (BMO), will address manufacturing needs of Somatic Cells, Non-Viral Modified Cells, Vesicles and Plasmids for Viral Vectors. [Read more…]
Magenta Therapeutics Awarded an FDA RMAT for MGTA-456
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…]
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