Cerebral palsy is a neurological condition that affects thousands of babies born every year. Damage or malformation of the brain during development, most often in the womb, leads to motor and muscle symptoms. Children with cerebral palsy face a lifelong disability with consequences ranging from being wheelchair bound to painful, tight muscles and joints and even hearing loss, vision loss, cognitive deficits, and many more symptoms and complications that vary by individual. [Read more…]
Cord Blood
Because cord blood present within a newborn’s umbilical is rich with stem cells, it can be collected and stored for future medical use.
Cellenkos’ Cord Blood T-Regulatory Cells Show Promise in COVID-19 Induced ARDS
HOUSTON, July 6, 2020 — Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos®), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. [Read more…]
Gamida Cell, President Dr. Yael Margolin Reveals the Unmet Need in HSCT
Gamida Cell is a cell therapy company that is best known for its innovative approaches to hematopoietic stem cell transplantation (HSCT). Headquartered in Jerusalem, Israel, Gamida Cell has been advancing several clinical programs using ex vivo expanded hematopoietic stem cells (HSCs) created using its proprietary nicotinamide (NAM) technology.
I had the honor of interviewing Dr. Yael Margolin, President of Gamida Cell. In this interview, we discuss how Gamida Cell is using cell therapeutics to address the unmet need in hematopoietic stem cell transplantation (HSCT). [Read more…]
CRISPR Therapeutics and Vertex Pharmaceuticals Win RMAT for CTX001™
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CRISPR Therapeutics and Vertex Pharmaceuticals Have Been Awarded an FDA RMAT Designation for CTX001™ in the Treatment of Severe Hemoglobinopathies
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CTX001 has received Orphan Drug Designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the European Medicines Agency (EMA) for sickle cell disease and transfusion-dependent beta thalassemia
ZUG, Switzerland and Cambridge, MA, May 11, 2020 — CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. FDA RMAT designation to CTX001, an investigational, autologous, gene-edited hematopoietic stem cell therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). [Read more…]
TissueTech Receives RMAT from FDA for Human Umbilical Cord Product, TTAX02
RMAT designation reinforces clinical significance of investigational biologic product TTAX02 used during in-utero fetal surgical repair of spina bifida.
MIAMI, April 16, 2020 — TissueTech, Inc., the pioneer in the development and clinical application of regenerative human birth tissue products, announced today that the U.S. Food and Drug Administration (FDA) has granted their cryopreserved human umbilical cord investigational biologic product TTAX02 RMAT designation for the treatment of spina bifida in-utero.
[Read more…]
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