Viable Bone Marrow-Derived Mesenchymal Stem Cells (BM-MSCs)
A Consistent, Ready-to-Use BM-MSC Product
- Designed to alleviate pain, increase joint function and speed wound healing.
- Sourced from screened, healthy donors ages 18-25; no painful aspiration process
- Fully characterized for biological activity
- Animal-origin-free and DMSO-free manufacturing platform, designed to preserve cell quality and efficacy
The Most Established Clinical Evidence
Bone-marrow MSCs, like mCELL™, have the most established clinical evidence and the only lineage with an FDA-approved therapeutic precedent.
Outperforms Umbilical MSCs
Greater IDO activity and VEGF secretion in standardized laboratory testing
FDA-Approved Precedent
Only MSC source represented in an FDA-approved therapy
Deepest Orthopedic Evidence Base
Phase 3 knee OA data (146 pts) and randomized DDD data (100 pts; 36 mo)
Rationale Grounded in Anatomy
Physiologic stem-cell source already leveraged by BMAC and microfracture
Sourcing & Delivery
From donor-bone marrow to your clinic
Bone Marrow Harvest
Screened, healthy donors age 18-25. 21 CFR 1271 compliant accredited institution.
Master Cell Bank
Qualified and selected for potency.
mCELL™ GMP Manufacturing
Fill, finish and release. DMSO-free cryopreservation.
mCELL™ Delivery
Shipping in a qualified -80°C container. Thaw and inject. Lot-specific COA.
Quality Standards & Third-Party Qualification
Manufactured in an FDA-registered, cGMP-compliant facility with 34+ years of operation
ISO 5 / ISO 7 cleanrooms, environmentally controlled and monitored 24/7
Validated aseptic process, qualified equipment, trained and accountable personnel
End-to-end lot traceability from donor to physician
Quality Assurance oversight and release
Donor eligibility and infectious-disease screening per 21 CFR Part 1271
Testing is performed by independent laboratories at both ends of the process.
Master Cell Bank
Independently qualified for sterility, mycoplasma, adventitious agents, identity, and karyotype/genetic stability.
Final Product
Every lot tested against predefined release specifications and documented on the Certificate of Analysis.
Safety & Identity
Sterility, endotoxin, mycoplasma, adventitious agents, and MSC surface markers.
Viability & Function
Post-thaw viability, immunomodulatory activity, and IDO.