Drug intelligence / Profile preview

MyoCell

Development stage
Phase 3
Lead developer
Bioheart
Modality
Stem Cell Therapies → Cell Therapies
Administration
Intramyocardial, Intramuscular
01

Overview

MyoCell is an autologous cell therapy consisting of cultured skeletal myoblasts (muscle stem cells) derived from a patient's own biopsy, typically from the vastus lateralis muscle. Developed by Bioheart (now U.S. Stem Cell), the therapy involves expanding these satellite cells in vitro and then transplanting them into damaged tissue, most notably the myocardium of patients with congestive heart failure or following a myocardial infarction. The therapeutic intent is for the myoblasts to differentiate into myotubes, integrate into the scarred heart tissue, and improve regional contractility and overall cardiac function. Delivery is typically achieved through specialized intramyocardial injection catheters such as MyoCath or MyoStar. While the therapy reached Phase II/III clinical trials (e.g., the MARVEL and SEISMIC studies), its development was hindered by regulatory challenges, and the manufacturer's Regenerative Medicine Advanced Therapy (RMAT) application was terminated in 2017.

Brand names
MyoCellMyoCell-S
Other names
autologous myoblast stem cell therapyautologous skeletal myoblastsautologous skeletal myoblast transplantationASMT

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