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

NCT05677672 | Unknown Phase 1

• 1 other identifier: TH-SC01-CAF-Ⅰ/Ⅱ 1.0
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas

Conditions

Complex Perianal Fistulas

Outcome Measures

Primary Outcomes (4)

• Severity and incidence of study drug-related adverse-events

  Severity and incidence of study drug-related adverse-events within D28(W4) after administration.

  Day 28 (Week 4)

• Dose-limiting toxicity (DLT)

  Exploration of dose-limiting toxicity (DLT)

  Day 28

• maximum tolerated dose (MTD)

  Exploration of maximum tolerated dose(MTD)

  Day 28

• Percentage of effectiveness

  Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion

  Day 84

Secondary Outcomes (1)

• Severity and incidence of study drug-related adverse-events

  Day 28

Other Outcomes (7)

• Patient quality of life score

  Week 1-Week 52

• Rate of recurrence

  Week 24-Week 104

• Closure time of fistulas

  Day 1

Study Arms (2)

Human TH-SC01 cell injection

EXPERIMENTAL

Human TH-SC01 Cell Injection is a human expanded umbilical cord mesenchymal stem cells suspension

Biological: Human TH-SC01 Cell Injection

Placebo-control group

PLACEBO COMPARATOR

Saline solution

Other: Saline solution

Interventions

Human TH-SC01 Cell Injection BIOLOGICAL

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

Human TH-SC01 cell injection

Saline solution OTHER

saline solution will be given at the same quantity 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 aged between 18 and 70, both male and female.
• The subject was clinically diagnosed as complex anal fistula. The diagnostic criteria for complex anal fistula were adopted by the 2016 American Association of Colorectal Surgeons Guidelines for the Treatment of Perianal Abscess, Anal Fistula and Rectovaginal Fistula.
• The subjects had received conventional treatment for anal fistulas
• 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 with anal fistula in the acute infection period.
• Subjects with abscess or collections \>2 cm.
• 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 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.
• The female participant who is pregnant, or is lactating.

Sponsors & Collaborators

• Jiangsu Topcel-KH Pharmaceutical Co., Ltd.: lead
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Xiangya Hospital Central University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1 was a non-randomized, single-arm, multicenter, dose-escalation clinical trial design. Phase 2 was a randomized, double-masking , multicenter, blank control, dose-extended clinical trial design.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 10, 2023
• Study Start: December 30, 2022
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 10, 2023

Record last verified: 2022-12

Locations

CN (1)