The release panel in full
| Test | Method | Acceptance criterion | Failure action |
|---|---|---|---|
| Identity | Flow cytometry immunophenotype | MSC marker profile confirmed | Batch discarded |
| Viability | Cell counting at release | Defined minimum met | Batch discarded |
| Sterility | Culture | No microbial growth | Batch discarded, investigation opened |
| Endotoxin | LAL assay | Within defined limit | Batch discarded |
| Mycoplasma | PCR | Not detected | Batch discarded, investigation opened |
| Dose | Cell count against protocol | Protocol dose achievable | Manufacture extended or repeated |
Traceability, donor to patient
- Consented donation of umbilical cord tissue after a normal birth
- Donor infectious-disease screening before tissue is accepted
- Batch record opened at isolation, carried through every expansion step
- Cleanroom environmental monitoring recorded per session
- Release certificate linked to the batch and to the receiving patient
- Retention of records enabling any adverse event to be traced to a batch
What happens when a batch fails
A failing batch is discarded. It is not administered at a lower dose, not released pending a repeat test, and not substituted quietly with another product.
Sterility and mycoplasma failures additionally trigger an investigation of the cleanroom session, the materials lot and the operator record before manufacture restarts.
Why we do not publish a single potency number
MSCs act through multiple pathways, and no consensus potency assay exists. Publishing one number would imply a comparability between laboratories that the field has not established.
We report the assays performed and their methods, so a reader can judge them, rather than a headline score.
Questions about this report
How to cite this report
StemCell Longevita (2026). Laboratory Transparency Report. Istanbul: StemCell Longevita GMP laboratory.
Reuse is permitted under CC BY 4.0 with a link back to https://stemcelllongevita.com/reports/laboratory-transparency. Corrections: contact the medical office.
Compiled by the StemCell Longevita medical office. Medically reviewed by Prof. Dr. Erdal Karaöz Team. Published . Method and definitions: editorial and evidence policy. This report is information about our own process and pricing, not medical advice and not a promise of clinical benefit.