Cook MyoSite


Cook MyoSite develops and manufactures human muscle-derived cell products and provides contract research and laboratory services to support muscle cell research and clinical development. The company operates ISO‑certified laboratories and cleanrooms, supplies characterized single-donor primary human muscle cells and progenitor cell populations for research use, offers specialized culture and cryostorage media, conducts analytical and QC testing, and pursues clinical development of autologous muscle-derived cell therapies via controlled clinical trials.

Industries

N/A

Nr. of Employees

small (1-50)

Cook MyoSite


Patents

Methods, substrates, and systems useful for cell seeding of medical grafts

US-12121631-B2

View Details

Products

Primary human skeletal muscle-derived cells (single-donor, RUO)

Cryopreserved, donor-characterized primary human skeletal muscle myoblast-like cells for research use only; shipped frozen with lot-level characterization and differentiation testing.

Fibro-adipogenic progenitor (FAP) cells (RUO)

Ready-to-use, purified human primary fibro-adipogenic progenitor cells for research use; characterized for dual differentiation potential (adipocyte and fibroblast markers).

Specialized culture and differentiation media

A family of culture media formulations optimized for primary muscle cell growth, differentiation and serum-free/insulin-free options for custom applications.

Cryostorage medium for mammalian cells

Cryostorage medium formulated to maintain high post-thaw viability of mammalian primary cells.


Services

Phase‑appropriate manufacturing of muscle and other adherent cell types using qualified equipment and controlled facilities.

Comprehensive QC testing and assay development including sterility, endotoxin, mycoplasma, flow cytometry, gene expression assays, microscopy and validated QC methods.

Procurement and processing of muscle tissue from specific donor populations, custom isolation workflows and cell preservation for shipping or storage.

Consulting for process development, technology transfer, technical writing, and clinical delivery planning for cell-based products.

Expertise Areas

  • Clinical trial management for cell therapies
  • Cellular manufacturing and cleanroom operations
  • Primary human muscle cell isolation and characterization
  • Analytical QC and assay development for biologics
  • Show More (4)

Key Technologies

  • Primary human cell isolation and culture
  • Cryopreservation and vapor-phase storage
  • Flow cytometry
  • RT‑PCR / gene expression profiling
  • Show More (8)

News & Updates

First participant treated in a randomized, placebo-controlled Phase III trial evaluating an autologous muscle-derived cell injection for chronic fecal incontinence with obstetric anal sphincter injury.

Clinical results reporting safety and efficacy from a Phase 1/2 study of autologous muscle-derived cell therapy for fecal incontinence.

Randomized, placebo-controlled clinical trial evaluating autologous muscle-derived cell therapy in female stress urinary incontinence.

Report of a double-blind, randomized, stratified, placebo-controlled trial of an autologous muscle-derived cell product for female stress urinary incontinence.

Regulatory authority granted Regenerative Medicine Advanced Therapy (RMAT) designation for autologous muscle-derived cell therapy across multiple indications.


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