Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

NCT06925594 | Recruiting Phase 3 DMC

• 1 other identifier: TH-SC01-CD-Ⅲ-01
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects achieved combined remission

  Combined Remission of perianal fistulising Crohn's disease defined as the all treated external openings achieved clinical remission at week 24， and absence of collections \> 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24.

  24 weeks

Secondary Outcomes (11)

• The proportion of subjects achieved clinical remission

  24 weeks ，52 weeks and104 weeks

• The proportion of subjects achieved a clinical response

  24 weeks，52 weeks and104 weeks

• The proportion of subjects recurrence

  24 weeks，52 weeks and104 weeks

• Time to achieve clinical remission, clinical response and recurrence

  24 weeks，52 weeks and104 weeks

• The proportion of subjects achieved combined remission

  52 weeks and104 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

120 million cells administered by intralesional injection.

Other: Human TH-SC01 cell injection

Placebo-control group

PLACEBO COMPARATOR

24 mL saline solution by intralesional injection

Other: Saline solution

Interventions

Human TH-SC01 cell injection OTHER

Human TH-SC01 cell injection is a cell suspension in aseptic buffered solution containing human expanded umbilical cord-derived stem cells of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection.

Treatment Arm

Saline solution OTHER

Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule.

Placebo-control group

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.
• Presence of perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• American Society of Anesthesiologists (ASA) physical status classification of grade I to grade II.
• 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.

You may not qualify if:

• Subjects allergic to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drugs or MRI contrast agents.
• Subjects with active infection evaluated by the investigator
• Subjects with active Crohn's disease before drug administration or have not completed the induction-phase treatment.
• Subjects with abscess or collections \>2 cm.
• Rectal and/or anal stenosis , if this means a limitation for any surgical procedure
• Subjects with concurrent active proctitis.
• Subjects with other fistulas such as rectum/anal canal-vaginal fistulas or rectum-bladder fistulas.
• Patients have undergone a diverting stoma operation in the past, except for patients have completed stoma closure at least one month before drug administration.
• Patients plan to undergo surgery in the perianal area during the trial period due to other diseases other than anal fistula.
• 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).
• Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
• Subjects with malignant tumors or a history of malignant tumors.
• Subjects with congenital or acquired immunodeficiency.
• Contraindication to MRI scan
• Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jueyu Xia, Master

CONTACT

025-52700103; xiajueyu@topcelbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): June 28, 2028
• Last Updated: April 13, 2025

Record last verified: 2025-03

Locations

CN (1)