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NCT04939337
Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
Phase 1 trial testing TH-SC01 in Crohn's Disease in 24 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Jinling Hospital, China |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 12 November 2020 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 August 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- TH-SC01 — full drug profile →
Conditions studied
- Crohn's Disease — all drugs for Crohn's Disease →
Sponsor
Jinling Hospital, China
Who can join
Adults 18 to 70, any sex, with Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants who Achieve Combined Remission
Time frame: 24 weeks
Combined remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of abscess(es) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment or transrectal ultrasonography(TRUS)
Sponsor's own description
The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic potential of mesenchymal stem/stromal cells (MSCs)-based cell therapy for inflammatory bowel diseases (IBD) therapy.
Saadh MJ, Mikhailova MV, Rasoolzadegan S, Falaki M, et al · · 2023 · cited 45× · PMID 36707899 · DOI 10.1186/s40001-023-01008-7 -
Mesenchymal stem cells in treating human diseases: molecular mechanisms and clinical studies.
Han X, Liao R, Li X, Zhang C, et al · · 2025 · cited 34× · PMID 40841367 · DOI 10.1038/s41392-025-02313-9 -
Efficacy and safety of allogeneic umbilical cord-derived mesenchymal stem cells for the treatment of complex perianal fistula in Crohn's disease: a pilot study.
Wei J, Zhang Y, Chen C, Feng X, et al · · 2023 · cited 13× · PMID 37904247 · DOI 10.1186/s13287-023-03531-0 -
Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.
Nikolaev G, Lozenov S, Konaktchieva M, Arabadzhiev B, et al · · 2026 · PMID 42193425 · DOI 10.3390/biomedicines14051102 -
Modular mastery of inflammation: umbilical cord mesenchymal stem cells as a therapeutic frontier.
Yin L, Sun CY, Chen GL, Xiang Z, et al · · 2025 · PMID 41488628 · DOI 10.3389/fimmu.2025.1721947 -
Efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells for the Treatment of Complex Perianal Fistula in Crohn's Disease：A Pilot Study
Wei J, Zhang Y, Chen C, Feng X, et al · · 2023 · DOI 10.21203/rs.3.rs-2270943/v1
Verify or expand the search:
- PubMed search for NCT04939337
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jinling Hospital, China trials
Trials by the same sponsor.
- NCT07297238 — Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration. · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04939337 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jinling Hospital, China
- Last refreshed: 24 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04939337.
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