FDA authorizes new IND for the study of CLBS119 in COVID-19 patients who experienced respiratory failure

BASKING RIDGE, N.J. (April 23, 2020) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease today announced that the U.S. Food and Drug Administration (“FDA”) has authorized its investigational new drug (“IND”) application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage. The study will target patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure. [Read more…]

Immunotherapy companies led by Dr. Patrick Soon-Shiong are developing potential coronavirus therapeutics and vaccines to address the evolving stages of disease from moderate infection to severe acute respiratory distress syndrome (SARS).

• Therapeutic for Severe and Critically Ill COVID-19 Patients on Ventilator Support:
  • NantKwest’s MSCs: Bone marrow-derived mesenchymal stem cells (MSC) to mitigate ‘cytopathic storm’ [Read more…]

FDA Authorizes Cure Alliance Rxperts to Test UC-MSCs

THE CURE ALLIANCE, April 9, 2020 — After a lightening round of proposals and reviews, an international team of scientists led by Dr. Camillo Ricordi was granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19. [Read more…]