What research stage is stem-cell therapy for Chronic Wounds & Ulcers at?
The ladder for this condition: 7 Phase 3 or 4 records out of 53 registrations in total, snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 26 | 41% |
| Phase 2 | 19 | 30% |
| Phase 3 | 7 | 11% |
| Not applicable | 7 | 11% |
| Early Phase 1 | 4 | 6% |
What the phase mix means for Chronic Wounds & Ulcers
There is real later-phase activity, with complete-closure endpoints that regulators accept. That makes this a useful benchmark for what a mature cell-product evidence package actually looks like.
The later-phase studies themselves
| 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 |
| 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 |
| NCT06140303 — SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II) | Phase 3 | Active Not Recruiting | 100 | PolarityTE | 2024-02-22 |
| NCT00434616 — Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia | Phase 2, Phase 3 | Unknown | 90 | Franziskus-Krankenhaus | 2007-04 |
How to read phase labels
Phase 1 asks whether a dose is tolerated, usually in a small group without a control arm. Phase 2 looks for a signal and refines dosing. Phase 3 is confirmatory: larger, controlled, powered to test whether the intervention changes an outcome that matters. Not applicable appears for observational studies or where the sponsor assigned no phase, which is common in cell therapy and not a quality mark either way.
Median planned enrolment across sampled studies here is 48 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02796079 — A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications | Phase 1 | Unknown | 240 | Jie Shen | 2015-01 |
| NCT02831075 — A Clinical Study Using Adipose-derived Stem Cells for Diabetic Foot | Phase 1 | Unknown | 240 | Jie Shen | 2015-01 |
| NCT02834858 — Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications | Phase 1 | Unknown | 240 | Jie Shen | 2016-01 |
| NCT06681428 — Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | n/a | Recruiting | 240 | Tides Medical | 2024-11-14 |
| 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 |
Frequently asked
What research stage is stem-cell therapy for Chronic Wounds & Ulcers at?
7 of 53 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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