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NCT06429241
A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Phase 1 trial testing Mesenchymal Stem Cells (MSCs) in Anal Fistula in 8 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Jiangsu Topcel-KH Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 8 April 2024 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Mesenchymal Stem Cells (MSCs) — full drug profile →
Conditions studied
- Anal Fistula — all drugs for Anal Fistula →
- Complex Perianal Fistulas — all drugs for Complex Perianal Fistulas →
- Crohn's Disease — all drugs for Crohn's Disease →
Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Anal Fistula or Complex Perianal Fistulas. 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.
-
Standardized uptake value
Time frame: 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour
Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula
Sponsor's own description
The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Advancing therapeutic frontiers: a pipeline of novel drugs for luminal and perianal Crohn's disease management.
Bertin L, Crepaldi M, Zanconato M, Lorenzon G, et al · · 2024 · cited 10× · PMID 39711916 · DOI 10.1177/17562848241303651
Verify or expand the search:
- PubMed search for NCT06429241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mesenchymal Stem Cells (MSCs)
Trials testing the same drug.
- NCT06149832 — Treatment of Oral Chronic Graft-versus-host Disease With Human Umbilical Cord Mesenchymal Stem Cell Dressing · Phase 4 · unknown
- NCT05284604 — Mesenchymal Stem Cells for Age-Related Frailty · Phase 1, PHASE2 · withdrawn
- NCT04361942 — Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stem Cells · Phase 2 · completed
- NCT04061746 — Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells · Phase 1 · recruiting
- NCT02804945 — Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies · Phase 1 · completed
Other recruiting trials for Anal Fistula
Currently open trials in the same condition.
- NCT07477496 — Recurrence and Anal Fistula Patient Reported Outcomes Trial · recruiting
- NCT07081373 — Study on Repeat Liposomal Bupivacaine for Post-Surgery Pain in Anal Fistula Patients. · NA · recruiting
- NCT06803550 — Effect of Enhanced Recovery After Surgery for Benign Anorectal Conditions · NA · recruiting
- NCT06303752 — Tissue Therapy of Transsphincteric Anal Fistula · Phase 1, PHASE2 · recruiting
- NCT05641844 — A Double Blind, Randomized Controlled Study, Evaluating the Safety and Efficacy of RD2 Ver.02 For the Management of Anal · NA · recruiting
Other Jiangsu Topcel-KH Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07452822 — Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in · Phase 1, PHASE2 · not yet recruiting
- NCT06925594 — Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease · Phase 3 · recruiting
- NCT05677672 — The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Com · Phase 1, PHASE2 · unknown
- NCT05626023 — A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease · Phase 1, PHASE2 · completed
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 NCT06429241 (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 Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Last refreshed: 10 June 2024
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/NCT06429241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing