BioCardia Completes Phase III Clinical Trial of Autologous Stem Cell Therapy for Ischemic Heart Failure
BioCardia, Inc., a leader in cellular therapies for cardiovascular diseases, has announced the completion of its pivotal Phase III trial for CardiAMP®, an autologous cell therapy designed to treat ischemic heart failure with reduced ejection fraction (HFrEF). This milestone marks the last patient follow-up in the double-blind, placebo-controlled trial, which aims to assess the safety […]
MaxCyte and Kamau Therapeutics Partner to Accelerate Gene Correction with Groundbreaking Stem Cell Therapies for Genetic Diseases
In a groundbreaking move for stem cell therapies, MaxCyte, Inc. has entered into a strategic platform license agreement with Kamau Therapeutics, a clinical-stage company focused on gene correction. The collaboration will leverage MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to expedite the development of innovative therapies targeting genetic diseases. Kamau’s platform, built on homology-directed repair […]
Somite Therapeutics Achieves Key Milestone with FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophy
Somite Therapeutics has announced a major breakthrough in the fight against Duchenne Muscular Dystrophy (DMD), securing both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA for their lead therapeutic candidate, SMT-M01. These designations are critical in the development of therapies targeting rare diseases, offering benefits such as tax credits for […]
Stemregen Partners with Liquivida Wellness Center to Revolutionize Healthy Aging Through Stem Cell Supplementation
In an exciting development for the longevity and wellness industry, Stemregen®, a leader in stem cell science-backed supplements, has announced a strategic partnership with Liquivida® Wellness Center, a full-service wellness franchise. This collaboration will allow Stemregen’s innovative line of stem cell-boosting supplements to be offered at Liquivida’s flagship location in Fort Lauderdale, Florida, with plans […]
HepaTx and Mayo Clinic Collaborate to Accelerate Cell Therapy for Liver Disease to Clinical Trials
HepaTx, a biotechnology company focused on regenerative medicine, has announced an exciting collaboration with the Mayo Clinic to advance its innovative cell therapy technology into clinical trials. This partnership, revealed on September 10, 2024, aims to offer new therapeutic approaches for liver diseases, initially targeting alcohol-related hepatitis. The collaboration leverages Mayo Clinic’s clinical research infrastructure […]
FDA Accepts BLA for Ryoncil: First Allogeneic “Off-the-Shelf” Cellular Medicine and First Cell Therapy for Children in the United States
In a significant milestone for pediatric medicine, the FDA has accepted Mesoblast’s Biologics License Application (BLA) for Ryoncil® (remestemcel-L), aimed at treating children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD). This acceptance marks a crucial step towards the approval of the first allogeneic “off-the-shelf” cellular medicine in the United States, and the first cell therapy for […]
Breakthrough in Muscular Dystrophy Treatment: FDA Approves Stem Cell Therapy from Myogenica
The fight against muscular dystrophy has taken a promising turn with the recent FDA approval of an Investigational New Drug (IND) application for MyoPAXon, a revolutionary stem cell-derived muscle stem cell product developed by Myogenica, a University of Minnesota startup. This landmark approval paves the way for a clinical trial aimed at treating patients with […]
Revolutionary Stem Cell Treatment for Hair Loss: Eirion Therapeutics Leads the Way
Eirion Therapeutics, a pioneer in stem cell research, has announced the commencement of a groundbreaking Phase 1 clinical trial to evaluate the safety of ET-02, a topical pharmaceutical designed to treat androgenic alopecia, commonly known as age-related hair loss. This double-blind, placebo-controlled study marks a significant milestone in the treatment of hair loss, enrolling the […]
BrainStorm Cell Therapeutics Aligns with FDA on Phase 3b NurOwn Clinical Trial CMC Aspects
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has reached an important milestone by aligning with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn®, an investigational therapy for amyotrophic lateral sclerosis (ALS). This […]
Controversial Utah Bill Threatens FDA’s Authority Over Stem Cell Therapies
In a concerning development for the field of stem cell research and therapy, the International Society for Cell & Gene Therapy (ISCT) has voiced its opposition to a proposed bill in Utah that could undermine the U.S. Food and Drug Administration’s (FDA) ability to regulate stem cell products and protect patient safety. The bill, known as the “Right to […]