Identification of the safety and curative effect of organoid-based autologous intestinal stem cell therapy in patients with Behcet's enteritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007693
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 10
1) 19 years of age or older
2) Patients with severe Behcet's enteritis who have been treated with anti-TNFa for more than 1 year
3)A patient with an intestinal ulcer with a long axis greater than 10 mm and measurable by colonoscopy
4) Patients whose intestinal ulcer size measured at the time of examination is reduced or enlarged by less than 50% compared to that measured at the previous visit.
5) Patients who understand the purpose of this clinical trial, voluntarily decides to participate in this clinical trial, and agrees in writing to comply with restrictions
Patients who fall under any of the following are not eligible to participate in this clinical study.
1) Suspected type and indeterminate colitis
2) Patients with autoimmune diseases other than Behcet's disease
3) Patients with serious complications requiring surgical intervention such as severe stricture, perforation, large abscess, and massive gastrointestinal bleeding.
4) Patients with malignant tumors including colorectal cancer
5) Patient who underwent bowel resection within the last 6 months or intra-abdominal surgery within 3 months
6) Patients with a history of infectious diseases within one month of screening
7) Patients for whom bowel preparation for colonoscopy is contraindicated
8) Patients with hypersensitivity to bovine protein or fibrin glue
9) Pregnant or lactating women
10) As male subjects who are women of childbearing age and sexual partners of women of childbearing potential, ? very effective contraceptive methods (hormonal contraception, intrauterine device (IUD (Intrauterine device), IUS (Intrauterine system) , vasectomy, tubal ligation, etc.); or not promising the use of a double barrier (male condoms, female condoms, cervical caps, diaphragms or contraceptive sponges) when highly effective methods of contraception are not available; or ? If you do not promise not to donate sperm until the end of the clinical trial
11) Patients with a history of participating in clinical trials within the last 30 days
12) Patients with inability to communicate that could interfere with safety and other assessments
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess ATORM-C safety 1) Frequency and characteristics of all adverse reactions after ATORM-C administration 2) After applying ATORM-C, AESI frequency and patterns (1) Hypersensitivity reaction (2) Procedure-related infection 3) Changes in vital signs and physical examination after applying ATORM-C compared to baseline 4) Safety and changes of laboratory tests compared to baseline after application of ATORM-C
- Secondary Outcome Measures
Name Time Method