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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2023-12-30

Brief Summary

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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

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Detailed Description

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This study is a phase Ⅰ/Ⅱ study, Phase 1 was the dose increment phase, and phase 2 was the expansion phase

Conditions

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Complex Perianal Fistulas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Human TH-SC01 cell injection

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

Group Type EXPERIMENTAL

Human TH-SC01 Cell Injection

Intervention Type BIOLOGICAL

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

Placebo-control group

Saline solution

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type OTHER

saline solution will be given at the same quantity and following the same schedule

Interventions

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Human TH-SC01 Cell Injection

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

Intervention Type BIOLOGICAL

Saline solution

saline solution will be given at the same quantity and following the same schedule

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent.
2. Subjects aged between 18 and 70, both male and female.
3. 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.
4. The subjects had received conventional treatment for anal fistulas
5. 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.

Exclusion Criteria

1. Subjects with anal fistula in the acute infection period.
2. Subjects with abscess or collections \>2 cm.
3. 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).
4. Subjects with malignant tumors or a history of malignant tumors.
5. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
6. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
7. Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
8. Subjects allergic to MRI contrast.
9. Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
10. Subjects who has received any investigational drug within 3 months prior to the screening.
11. Subjects deemed inappropriate by the investigator to participate in this clinical trial.
12. The female participant who is pregnant, or is lactating.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No