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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed informed consent. 2. 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). 3. Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200. 4. Subjects with perianal fistula confirmed by clinical assessment and MRI. 5. Subjects aged between 18 and 70, both male and female. 6. 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. 7. 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.

Exclusion Criteria:

1. Subjects with active infection evaluated by the investigator. 2. Subjects with Crohn's disease requiring immediate therapy. 3. Subjects with abscess or collections >2 cm. 4. Subjects with rectal and/or anal stenosis and/or active proctitis. 5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration. 6. 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). 7. Subjects with malignant tumors or a history of malignant tumors. 8. Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases. 9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive. 10. Subjects allergic to gentamicin sulfate, anesthetics or contrast media. 11. Subjects allergic to MRI contrast. 12. Subjects who has received stem cells in a previous clinical study or as a therapeutic agent. 13. Subjects who has major surgery or severe trauma within 6 months prior to the screening period. 14. Subjects who has received any investigational drug within 3 months prior to the screening. 15. Subjects deemed inappropriate by the investigator to participate in this clinical trial. 16. The female participant who is pregnant, or is lactating.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05626023
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Perianal Fistula, Crohn's Disease
Additional Details

This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.

Arms & Interventions

Arms

Experimental: Human TH-SC01 cell injection

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

Interventions

Drug: - Human TH-SC01 cell injection

Single injection of human TH-SC01 cell injection

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Zhaoshen Li, Dr.

zhaoshen-li@hotmail.com

021-81873241

For additional contact information, you can also visit the trial on clinicaltrials.gov.