What actually defines a mesenchymal stromal cell
The term "mesenchymal stem cell" gets used loosely, but the field has a specific definition. The International Society for Cell & Gene Therapy (ISCT) published minimal criteria in 2006 requiring three things together: plastic adherence under standard culture conditions, expression of specific surface markers (CD73, CD90 and CD105) alongside the absence of hematopoietic markers, and demonstrated tri-lineage differentiation into bone, cartilage and fat cell types in culture.
This matters for a procurement conversation because none of those three criteria can be confirmed by looking at a vial, a product label, or a marketing description. They are lab findings that require culturing the material and running defined assays. A supplier calling a product a "stem cell" product is making a claim about live, functionally defined cells, not a cosmetic description of the tissue it was recovered from.
Why "umbilical cord allograft" and "stem cell product" are not interchangeable
An umbilical cord allograft is a tissue product recovered from donated cord tissue and processed for distribution: cryopreserved, lyophilized, or otherwise preserved. Whether that processed material contains cells that meet the ISCT minimal criteria is a separate, empirical question that depends on the recovery method, the processing method, and what happened to cell viability along the way.
No MSC-based product is currently FDA-approved for orthopedic use, and the label on a vial does not establish what is inside it. For commercial cord tissue allografts specifically, the published cell-content analyses described below generally do not support calling these products "stem cell" products as a factual matter.
What published cell-content analyses report
A 2026 analysis of six commercial Wharton's jelly products found low total cell counts and low viability across the products tested, with only rare viable mesenchymal stromal cells identified. A separate 2021 study examining five commercial umbilical cord allograft products found no colony-forming mesenchymal stromal cells in any of them. Colony formation is one of the standard ways researchers test whether cells recovered from a tissue sample are still capable of growing in culture.
Published evidence on Wharton's jelly-derived material more broadly is still early-stage and largely made up of small studies, which is a separate point from the cell-content question above. Together, these findings are why documentation, not the word "stem cell" on a product label, is the most reliable way to know what a specific commercial lot actually contains.
What this means for labeling and marketing decisions
If a distributor cannot produce lab documentation showing a specific lot meets the ISCT minimal criteria, calling that lot a "stem cell" product is a factual claim that the available published evidence does not generally support for commercial cord tissue allografts. This is a labeling and compliance question as much as a scientific one: FDA has cited disease and therapeutic claims on distributor and clinic websites in recent warning letters, and overstating cell content is a related category of risk.
The more defensible description for this category of product is "umbilical cord tissue allograft" or "Wharton's jelly product," language that describes what was recovered and processed without asserting a live-cell functional claim that current documentation does not back up.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Questions to ask before accepting a cell-content claim
Any supplier asserting viable mesenchymal stromal cell content in a specific product should be able to answer: what assay was used to confirm viability, was colony-forming potential tested, were surface markers (CD73/CD90/CD105) confirmed by flow cytometry, and was tri-lineage differentiation demonstrated for that material specifically, not for umbilical cord tissue in general.
- What viability assay was run, and on which lot?
- Was colony-forming potential tested, and what was the result?
- Were CD73/CD90/CD105 markers confirmed by flow cytometry?
- Was tri-lineage differentiation demonstrated for this specific material?
Frequently asked questions
What are the ISCT minimal criteria for a mesenchymal stromal cell?+
Plastic adherence under standard culture conditions, expression of CD73, CD90 and CD105 with absence of hematopoietic markers, and demonstrated tri-lineage differentiation into bone, cartilage and fat cell types.
Do commercial Wharton's jelly products generally contain viable mesenchymal stem cells?+
Published cell-content analyses of commercial products have generally reported low cell counts, low viability and rare or absent colony-forming mesenchymal stromal cells, which does not support broad "stem cell" labeling claims.
Is any mesenchymal stem cell product FDA-approved for orthopedic use?+
No. No MSC-based product is currently FDA-approved for orthopedic use.
What should I ask a supplier before accepting a cell-content claim about their product?+
Ask what viability assay was used, whether colony-forming potential was tested, whether surface markers were confirmed by flow cytometry, and whether tri-lineage differentiation was demonstrated for that specific lot or material.
Sources
- Minimal criteria for defining multipotent mesenchymal stromal cells (ISCT position statement, 2006) ↗PubMed
- Critical evaluation of compositions and clinical relevance of Wharton's jelly-derived biologics ↗PMC
- Colony forming potential and protein composition of commercial umbilical cord allograft products ↗Am J Sports Med
- Umbilical cord-derived Wharton's jelly for regenerative medicine: a systematic review ↗PMC