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…]
Stem Cell News
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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…]
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…]
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…]
denovoMATRIX Introduces Ready-to-use, Chemically Defined Coated Cell Cultureware for Serum-free hMSC Expansion
August 22, 2019, Dresden, Germany — Due to their high accessibility and extensive beneficial properties, human Mesenchymal Stem Cells (hMSC) offer exciting promises in a plethora of applications in regenerative medicine, particularly in cell-based therapies. The major challenge of hMSC-based therapy is the large-scale expansion of cells in order to achieve the cell numbers necessary for therapeutic treatment. [Read more…]
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