TH-SC01 / Topcel-KH Pharma - LARVOL DELTA

Phase I Trial of Umbilical Cord-derived Mesenchymal Stem Cells (TH-SC01) in the Treatment of Complex Cryptoglandular Anal Fistula (ASGCT 2026) - "The medium-dose was effective in terms of fistula closure, pain relief, anal function preservation and quality of life improvement. These findings provide important support for dose selection and protocol design in subsequent Phase II clinical trials."

P1 data • Gastrointestinal Disorder

Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cells (TH-SC01) in Patients with Perianal Fistula in Crohn's Disease: Phase 1 and 2 Clinical Trials (ASGCT 2025) - "Intralesional administration of 120 million TH-SC01 cells might be safe and effective for treatment-refractory pfCD. These findings warrant further investigation in an ongoing randomised phase 3 trial. Disease Focus of Abstract:Autoimmune Disorders"

Clinical • P1 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

New P1 trial

Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease (clinicaltrials.gov) - P3 | N=228 | Recruiting | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

New P3 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease (clinicaltrials.gov) - P1/2 | N=9 | Completed | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Feb 2025

Trial completion • Trial completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • TNFA

Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

New P1 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

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. (PubMed, Stem Cell Res Ther) - P1 | "The study demonstrated that local injection of TH-SC01 cells might be an effective and safe treatment for complex treatment-refractory pfCD after conventional and/or biological treatments fail (ClinicalTrials.gov ID, NCT04939337)."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease

A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Jinling hospital Nanjing, Jiangsu, China

New P1 trial

The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

New P1/2 trial • Gastrointestinal Disorder

A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease (clinicaltrials.gov) - P1/2 | N=9 | Not yet recruiting | Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

New P1/2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • TNFA