TH-SC01 / Topcel-KH Pharma - LARVOL DELTA

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