Actively Recruiting
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Led by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Updated on 2024-06-12
8
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
CONDITIONS
Official Title
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed with Crohn's disease or complex perianal fistula at least 6 months ago
- Active perianal fistula with 1 to 2 internal openings and 1 to 3 external openings, with fistula drainage functioning smoothly
- Both participant and partner agree to use effective non-drug contraception and are not planning to have a child during the trial
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 and American Society of Anesthesiologists (ASA) grade I to II
- Have failed to respond to adequate treatment with conventional antibiotics, immunomodulatory drugs (including steroids), anti-TNF-alpha monoclonal antibodies and other biological agents
You will not qualify if you...
- Have an active infection
- Require immediate therapy for Crohn's disease
- Have abscess or collections larger than 2 cm
- Have rectal and/or anal stenosis or active proctitis
- Have used systemic steroids within 4 weeks before stem cell administration
- Have abnormal liver function (total bilirubin ≥1.5 × ULN, AST or ALT ≥2 × ULN) or renal function (creatinine clearance below 60 mL/min or serum creatinine ≥1.5 × ULN)
- Have malignant tumors or a history of malignant tumors
- Have severe, progressive, uncontrolled diseases affecting liver, blood, gastrointestinal system (except Crohn's), endocrine, lung, heart, nervous system, psychiatric or brain
- Test positive for hepatitis B e antigen, hepatitis C antibody, HIV antibody, or syphilis antibody
- Are allergic to human serum albumin, human platelet lysate, gentamicin sulfate, or anesthetic drugs
- Have previously received stem cell therapy
- Had major surgery or severe trauma within 6 months before screening
- Have taken any investigational drug within 3 months before screening
- Are pregnant or lactating (female participants)
- Are not suitable for PET/CT examination
- Are deemed inappropriate to participate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
M
Miu Li Yan The First Affiliated Hospital of Soochow University
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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