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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

Primary Purpose

Complex Perianal Fistulas

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human TH-SC01 Cell Injection
Saline solution
Sponsored by
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Perianal Fistulas

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Xiangya Hospital Central University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Human TH-SC01 cell injection

Placebo-control group

Arm Description

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

Saline solution

Outcomes

Primary Outcome Measures

Severity and incidence of study drug-related adverse-events
Severity and incidence of study drug-related adverse-events within D28(W4) after administration.
Dose-limiting toxicity (DLT)
Exploration of dose-limiting toxicity (DLT)
maximum tolerated dose (MTD)
Exploration of maximum tolerated dose(MTD)
Percentage of effectiveness
Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2022
Last Updated
December 28, 2022
Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Collaborators
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05677672
Brief Title
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
Official Title
Phase I/Ⅱ Study to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2022 (Anticipated)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Collaborators
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Perianal Fistulas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Human TH-SC01 cell injection
Arm Type
Experimental
Arm Description
Human TH-SC01 Cell Injection is a human expanded umbilical cord mesenchymal stem cells suspension
Arm Title
Placebo-control group
Arm Type
Placebo Comparator
Arm Description
Saline solution
Intervention Type
Biological
Intervention Name(s)
Human TH-SC01 Cell Injection
Intervention Description
Single injection of 0.6×10^7,1.2×10^8, 1.8×10^8 cells/kg
Intervention Type
Other
Intervention Name(s)
Saline solution
Intervention Description
saline solution will be given at the same quantity and following the same schedule
Primary Outcome Measure Information:
Title
Severity and incidence of study drug-related adverse-events
Description
Severity and incidence of study drug-related adverse-events within D28(W4) after administration.
Time Frame
Day 28 (Week 4)
Title
Dose-limiting toxicity (DLT)
Description
Exploration of dose-limiting toxicity (DLT)
Time Frame
Day 28
Title
maximum tolerated dose (MTD)
Description
Exploration of maximum tolerated dose(MTD)
Time Frame
Day 28
Title
Percentage of effectiveness
Description
Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
Severity and incidence of study drug-related adverse-events
Description
Severity and incidence of study drug-related adverse-events after D28(W4) after administration.
Time Frame
Day 28
Other Pre-specified Outcome Measures:
Title
Patient quality of life score
Description
Change from baseline in Patient quality of life score from W1-W52
Time Frame
Week 1-Week 52
Title
Rate of recurrence
Description
The recurrence rate after administration
Time Frame
Week 24-Week 104
Title
Closure time of fistulas
Description
Closure time of wound and fistula at the anal fistula surgical site after drug administration: Starting from the next day after administration (D1).
Time Frame
Day 1
Title
SF-36 score
Description
Change From Baseline in SF-36 score after administration,
Time Frame
Week 1-Week 52
Title
Van Assche Score
Description
Change From Baseline in Van Assche Score.Total score ranges from 0 to 10. Higher score means more pain.
Time Frame
Day 0-Week 52
Title
Wexner incontinence Score
Description
Change From Baseline in Wexner incontinence Score .Total score ranges from 0 to 20. Higher score means more severe disease.
Time Frame
Week 4-Week 52
Title
Anal sphincter function: rectal pressure
Description
Change from baseline in rectal pressure,In healthy people, the pressure ranges from 60 to 150mmHg, with the internal sphincter pressure accounts for about 80% and external sphincter pressure accounts for 20%.
Time Frame
Week 4-Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Xiangya Hospital Central University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Zhang, Dr.
Phone
073189753568
Email
davidcsu@foxmail.com

12. IPD Sharing Statement

Learn more about this 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

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