A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

NCT05626023 | Completed Phase 1

• 1 other identifier: TH-SC 2.0
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease

Conditions

Perianal Fistula; Crohn's Disease

Outcome Measures

Primary Outcomes (3)

• Severity and incidence of adverse events

  Severity and incidence of adverse events within 28 days after adiministration

  28 days

• Dose-limiting toxicity (DLT)

  Exploration of dose-limiting toxicity (DLT)

  84 days

• Maximum tolerated dose (MTD)

  Exploration of maximum tolerated dose (MTD)

  84 days

Secondary Outcomes (7)

• Perianal fistula healing

  84 days

• Crohn's Disease Activity Index (CDAI) score

  84 days

• Perianal Disease Activity Index (PDAI)

  84 days

• Inflammatory Bowel Disease Questionnaire（IBDQ）score

  84 days

• VAS score

  84 days

Study Arms (1)

Human TH-SC01 cell injection

EXPERIMENTAL

Single injection of 0.6×10\^7, 1.2×10\^8, 1.8×10\^8 cells/kg

Drug: Human TH-SC01 cell injection

Interventions

Human TH-SC01 cell injection DRUG

Single injection of human TH-SC01 cell injection

Human TH-SC01 cell injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Subjects with Crohn's disease diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).
• Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
• Subjects with perianal fistula confirmed by clinical assessment and MRI.
• Subjects aged between 18 and 70, both male and female.
• All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
• Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.

You may not qualify if:

• Subjects with active infection evaluated by the investigator.
• Subjects with Crohn's disease requiring immediate therapy.
• Subjects with abscess or collections \>2 cm.
• Subjects with rectal and/or anal stenosis and/or active proctitis.
• Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
• Subjects with abnormal laboratory results: liver function: total bilirubin \>=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine \>=1.5 × upper limit of normal (ULN).
• Subjects with malignant tumors or a history of malignant tumors.
• Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
• Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
• Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
• Subjects allergic to MRI contrast.
• Subjects who has received stem cells in a previous clinical study or as a therapeutic agent.
• Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
• Subjects who has received any investigational drug within 3 months prior to the screening.
• Subjects deemed inappropriate by the investigator to participate in this clinical trial.

Sponsors & Collaborators

• Jiangsu Topcel-KH Pharmaceutical Co., Ltd.: lead
• Changhai Hospital: collaborator

Study Sites (1)

Shanghai

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 23, 2022
• Study Start: January 30, 2022
• Primary Completion: August 30, 2023
• Study Completion: February 28, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)