RecruitingPhase 1NCT06429241
Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula
A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Enrollment
8 participants
Start Date
Apr 8, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria6
- Signed informed consent
- Subjects with Crohn\'s disease or complex perianal fistula diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤ 200.
- For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤ the number of external openings ≤3, the fistula of the patient needs to be drained smoothly
- 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.
- ECOG score 0\~1, ASA grade I\~II
- 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 Criteria17
- Subjects with active infection evaluated by the investigator.
- Subjects with Crohn\'s disease requiring immediate therapy.
- Subjects with abscess or collections \>2 cm.
- Subjects with rectal and/or anal stenosis and/or active proctitis.
- Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
- 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 Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
- Subjects who has received stem cells therapy.
- 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.
- Not suitable for PET/CT examination.
- Participants considered inappropriate to participate in this clinical trial
Interventions
BIOLOGICALMesenchymal Stem Cells (MSCs)
single dose injection (120 million cells)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06429241
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