Registry evidence

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.

Medical review statusMedically reviewedReviewed by: Stem Plus medical teamReviewed on: 2026-08-29Last evidence update: 2026-08-29Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

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.

MetricValue
Registered studies (all statuses)31
Interventional studies in the sample29
Recruiting right now1
Completed15
Terminated, withdrawn or suspended1
Phase 3 or Phase 4 records2
Countries with at least one site11
Median planned enrolment46 participants
Largest single planned enrolment240 participants
First / most recent start year2005 — 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1 of these records (3%) were terminated, withdrawn or suspended, against 15 marked completed; unfinished studies rarely appear in marketing summaries.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 labelRecordsShare
Phase 11850%
Phase 21131%
Not applicable411%
Phase 326%
Early Phase 113%

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.

CountryStudies with a site there
China9
South Korea4
United States4
Germany2
Australia1
Spain1
Israel1
Egypt1
Poland1
Italy1

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.

StudyPhaseStatusPlanned nLead sponsorStart
NCT07498218 — Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation TissuePhase 1Recruiting24Ayu, 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 3Completed104Anterogen Co., Ltd.2020-07-14
NCT03370874 — Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.Phase 3Completed150Anterogen Co., Ltd.2018-06-27
NCT06843122 — Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot (FOOTCELL)Phase 2Not Yet Recruiting105Medical University of Warsaw2025-03-08
NCT06231771 — Safety and Efficacy of Stem Cells for Diabetic Foot UlcerPhase 1, Phase 2Unknown22Supergenics Life Science Sdn. Bhd.2024-05
NCT04466007 — Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb IschemiaPhase 2Completed90Instituto de Investigación Sanitaria de la Fundación Jiménez2021-01-11
NCT04497805 — Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot UlcersPhase 2Unknown64Anterogen Co., Ltd.2020-09-08
NCT03754465 — Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot UlcersPhase 2Completed66Anterogen Co., Ltd.2019-01-02
NCT03865394 — Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem CellsPhase 1, Phase 2Completed46Medical University of Warsaw2019-07-01
NCT03267784 — Allogeneic ABCB5-positive Stem Cells for Treatment of DFU "Malum Perforans"Phase 1, Phase 2Completed23RHEACELL GmbH & Co. KG2017-11-21

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.

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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.