How strong is the evidence for stem-cell therapy in Chronic Wounds & Ulcers?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 53 records, 21 completed, 7 at Phase 3 or 4, and 4 stopped early (8%). MSC-specific work accounts for 31 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Chronic Wounds & Ulcers
The endpoint is complete wound closure confirmed at a later visit, against standard care including offloading. Photographs of a smaller wound at four weeks, without documented offloading, cannot separate the product from good basic care.
What we can say from registrations alone
- Volume: 53 registered studies since 2005.
- Maturity: 7 confirmatory-phase records.
- Delivery: 21 completed; 4 terminated, withdrawn or suspended.
- Scale: median planned enrolment 48 participants, largest 240.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04176120 — Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU) | Phase 3 | Completed | 220 | BioTissue Holdings, Inc | 2020-07-01 |
| NCT03370874 — Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers. | Phase 3 | Completed | 150 | Anterogen Co., Ltd. | 2018-06-27 |
| NCT03276312 — Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot | n/a | Completed | 112 | University of Modena and Reggio Emilia | 2015-04 |
| NCT06812637 — Efficacy and Safety of Wharton's Jelly-Derived Mesenchymal Stem Cell Exosomes in the Treatment of Diabetic Foot Ulcers: A Double-blinded Randomized Co | Phase 1 | Completed | 110 | Kafrelsheikh University | 2024-04-06 |
| NCT04450693 — Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II) | Phase 3 | Completed | 106 | BioTissue Holdings, Inc | 2020-11-20 |
| NCT04569409 — Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers. | Phase 3 | Completed | 104 | Anterogen Co., Ltd. | 2020-07-14 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Chronic Wounds & Ulcers research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Chronic Wounds & Ulcers?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 53 registered records, 7 at Phase 3/4 and 4 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Approval is product-and-indication specific and changes over time; check the FDA, EMA or your national regulator directly rather than relying on a clinic's summary.
Why do clinics cite hundreds of studies?
It converts activity into the appearance of proof. A hundred early-phase registrations do not add up to one adequately controlled result.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Chronic Wounds & Ulcers: cell-therapy evidence and registered trials
- How much does stem cell therapy for Chronic Wounds & Ulcers cost? (2026)
- Chronic Wounds & Ulcers stem cell therapy — your questions answered (2026)
- Chronic Wounds & Ulcers: cell-therapy evidence by therapy class
- MSC vs PRP for Chronic Wounds & Ulcers: what the registries show