Chronic Wounds & Ulcers and Mesenchymal stem/stromal cells (MSC): what the trial registry contains
The ClinicalTrials.gov registry holds 31 records for MSC in Chronic Wounds & Ulcers: 1 recruiting now, 2 labelled Phase 3 or 4, across 11 countries. Snapshot 2026-08-29.
Why this is studied in Chronic Wounds & Ulcers
The registry entries here centre on diabetic foot ulcers, where impaired healing reflects neuropathy, ischaemia and infection together. Cell and vesicle products aim to restore a functional healing environment. This is one of the few areas with a genuine regulatory precedent for advanced wound products, so evidence standards are comparatively well defined.
What MSC means in this table
Mesenchymal stromal cells are the workhorse of commercial cell therapy: easy to source from fat, cord or marrow, easy to expand, and rarely characterised in the same way twice. Their proposed action is paracrine — signalling molecules that damp inflammation — rather than replacement of lost tissue. That matters when reading counts like these, because two studies filed under the same label can test materially different products at different doses by different routes.
The numbers
Every figure below comes from one reproducible query (diabetic foot ulcer x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 31 |
| Interventional studies in the sample | 29 |
| Recruiting right now | 1 |
| Completed | 15 |
| Terminated, withdrawn or suspended | 1 |
| Phase 3 or Phase 4 records | 2 |
| Countries with at least one site | 11 |
| Median planned enrolment | 46 participants |
| Largest single planned enrolment | 240 participants |
| First / most recent start year | 2005 — 2026 |
How mature is this evidence?
Later-phase work exists but is not dominant (2 of 31), which is the typical profile of a field that has shown safety and is still testing whether benefit survives a control arm.
1 of these records (3%) were terminated, withdrawn or suspended, against 15 marked completed; unfinished studies rarely appear in marketing summaries.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 18 | 50% |
| Phase 2 | 11 | 31% |
| Not applicable | 4 | 11% |
| Phase 3 | 2 | 6% |
| Early Phase 1 | 1 | 3% |
Median planned enrolment is 46 participants (largest single study: 240). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
Country coverage runs to 11, but the distribution has a long tail behind China at about 36% of mentions.
| Country | Studies with a site there |
|---|---|
| China | 9 |
| South Korea | 4 |
| United States | 4 |
| Germany | 2 |
| Australia | 1 |
| Spain | 1 |
| Israel | 1 |
| Egypt | 1 |
| Poland | 1 |
| Italy | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is commercial (4 academic or hospital, 12 commercial among the most frequent lead sponsors).
- Anterogen Co., Ltd. — 7 records
- Jie Shen — 3 records
- Third Military Medical University — 2 records
- Medical University of Warsaw — 2 records
- Cynata Therapeutics Limited — 1 record
- Supergenics Life Science Sdn. Bhd. — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07498218 — Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue | Phase 1 | Recruiting | 24 | Ayu, Inc. | 2026-03-11 |
| 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 |
| 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 |
| NCT06843122 — Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot (FOOTCELL) | Phase 2 | Not Yet Recruiting | 105 | Medical University of Warsaw | 2025-03-08 |
| NCT06231771 — Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer | Phase 1, Phase 2 | Unknown | 22 | Supergenics Life Science Sdn. Bhd. | 2024-05 |
| NCT04466007 — Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia | Phase 2 | Completed | 90 | Instituto de Investigación Sanitaria de la Fundación Jiménez | 2021-01-11 |
| NCT04497805 — Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers | Phase 2 | Unknown | 64 | Anterogen Co., Ltd. | 2020-09-08 |
| NCT03754465 — Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers | Phase 2 | Completed | 66 | Anterogen Co., Ltd. | 2019-01-02 |
| NCT03865394 — Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells | Phase 1, Phase 2 | Completed | 46 | Medical University of Warsaw | 2019-07-01 |
| NCT03267784 — Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans" | Phase 1, Phase 2 | Completed | 23 | RHEACELL GmbH & Co. KG | 2017-11-21 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many MSC studies for Chronic Wounds & Ulcers are recruiting right now?
1 of 31 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is MSC an approved treatment for Chronic Wounds & Ulcers?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 31 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on MSC for Chronic Wounds & Ulcers?
2 of 31 records carry a Phase 3 or Phase 4 label and 15 are marked completed. Registrations run from 2005 to 2026.
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
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.