A cGMP-Manufactured Off-The-Shelf Bone-Marrow Stem Cell
mCELL™ is a donor sourced bone marrow-derived mesenchymal stromal cell product manufactured in an FDA-registered, cGMP facility, cryopreserved for off-the-shelf clinical use, and supplied exclusively to licensed physicians for localized use.
Bone marrow-derived mesenchymal stromal cells
30 million viable living cells
18 to 25 years
Cryopreserved, ready for thaw and immediate use
Product ships in a qualified dry ice package.
Meta-analyses of randomized controlled trials evaluating intra-articular MSC therapy consistently identify doses at or below 25 to 30 million cells as the tier associated with statistically significant functional improvement at 12 months. Increasing the dose beyond that threshold has not shown additional benefit. Excess cell concentration can reduce viability in the joint environment, where cells compete for limited space and nutrients. mCELL™ is calibrated at this clinically supported threshold.
mCELL™ comes with a lot-specific Certificate of Analysis (COA). A COA is a document that summarizes the testing and quality verification performed on a product before it is released for clinical use. It provides physicians with transparent, objective data about what is in a given lot and confirmation that it meets predefined quality and safety specifications.
For biologic products, a COA typically includes:
A COA is part of a broader quality system designed to ensure consistency, traceability, and compliance with applicable regulatory standards. It allows physicians to make informed decisions with confidence, based on clearly documented product characteristics for each lot.
mCELL™ is cryopreserved and shipped in a qualified dry ice package designed to maintain viability, cell count, and sterility during transport. TAVRA provides thawing instructions to the clinical site in advance of injection.
No on-site cell processing, manipulation, or centrifugation is required.
