SONOMA, Calif. – Pulthera, LLC has received notice from the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) that it can proceed with “A Phase 2b, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravenous Allogenic Bone Marrow-derived Mesenchymal Stem Cells in Subjects with Dyspnea Associated with Post-acuteContinue reading “FDA Allows Phase 2b Long COVID Study to Treat Patients Suffering from Long-COVID”
Author Archives: pulthera
ARDS in COVID-19 Patients Phase I Study
ProMedica today announced the promising results of its new study that evaluated the use of stem cells in the treatment of adult COVID-19 patients. Eight patients elected to participate in a study under Emergency Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA). Patients received either one or two doses ofContinue reading “ARDS in COVID-19 Patients Phase I Study”
FDA Approved Phase II Clinical Trial | ARDS in COVID-19 Patients
Stemedica Cell Technologies, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval for “A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients with Moderate to Severe Lung Injury due to COVID-19.” The study will enrollContinue reading “FDA Approved Phase II Clinical Trial | ARDS in COVID-19 Patients”