Cook MyoSite

Cook MyoSite, Inc. is a biotechnology company specialising in the development and commercialisation of autologous muscle-derived cell therapies for regenerative medicine applications.

Founded in 2002 and headquartered in Pittsburgh, Pennsylvania, Cook MyoSite, Inc. is dedicated to advancing muscle cell technology to develop innovative regenerative medicine therapies. The company focuses on the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. Its mission is to make regenerative medicine a part of everyday medicine by harnessing the restorative potential of the human body.

Cook MyoSite's investigational product, iltamiocel (Autologous Muscle Derived Cells), is currently being evaluated in clinical trials for conditions such as female stress urinary incontinence, fecal incontinence, and oropharyngeal dysphagia. The company has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its AMDC-USR product aimed at treating stress urinary incontinence in women.

In addition to its clinical research, Cook MyoSite offers a range of research products and services to support muscle cell research. These include primary human skeletal muscle-derived cells (skMDC) from diverse donor populations, custom media formulations, and contract research services. The company's laboratory facilities are ISO 9001:2015 certified, ensuring high-quality standards in its manufacturing and analytical processes.

Key Products and Services:

Iltamiocel (AMDC): An investigational autologous muscle-derived cell therapy under clinical evaluation for various muscle-related disorders.

Primary Human Skeletal Muscle-Derived Cells (skMDC): Single-donor cells characterised by age, gender, race, and BMI, available for research purposes.

Custom Media Formulations: Specialised media products, including the MyoTonic family, designed to optimise cell culture growth, differentiation, and cryopreservation.

Research Contract Services: Comprehensive services encompassing cell manufacturing, analytical testing, process development, and research support tailored to muscle cell innovation.

Laboratory Facilities: State-of-the-art laboratories equipped for GMP-compliant manufacturing and analytical testing, supporting both clinical and research activities.

With over two decades of experience in muscle cell technology, Cook MyoSite continues to lead in the field of regenerative medicine. Its commitment to quality, innovation, and collaboration positions the company as a trusted partner for researchers and clinicians aiming to develop effective treatments for muscle-related disorders. Through its ongoing clinical trials and comprehensive research services, Cook MyoSite strives to transform the potential of muscle cell therapies into tangible healthcare solutions.