None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Autologous intestinal epithelium-derived stem cells, ATORM-C (0.5 x 106 ~ 1.2 x 106 cells) in an amount corresponding to ulcer area were mixed with fibrin glue and appl
Sponsors
Koera University Guro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Explore ATORM-C efficacy. Ulcer size (endoscopic) related endpoints 1) After applying ATORM-C at each evaluation time, Percentage change in size from baseline [grade 0: mucosal] cure; Grade 1: Significant improvement (reduced to 1/4); Grade 2: Improvement (from ?1/2 to > 1/4); 3rd grade: no change or worsen (less than 1/2 reduced or expanded)] 2) Target ulcer size and baseline by evaluation time point Size change after applying ATORM-C (length of the longest shaft and based on the area of the ulcer) 3) Ratio by target ulcer size by evaluation point (?) does not exist; ? less than 10mm; ? 10mm to less than 20mm; ? 20 mm to less than 30 mm; ? 30mm to less than 40mm; ? 40mm ~ less than 50mm; ? 50mm or more) ? Biomarker-related endpoints 4) Serum CRP level after application of ATORM-C compared to baseline Change and rate of change (%) 5) Fecal calprotectin after applying ATORM-C compared to baseline (fecal calprotectin) change and rate of change (%) ? Variables related to the clinical course of Behcet's disease 6) Endoscopic evaluation and evaluation of ATORM-C after application Comprehensive change in gastrointestinal symptoms 7) New complications of Behçet's enteritis (perforation, fistula and massive bleeding; Abscess, stenosis, etc.) Frequency of occurrence 8) Conversion to surgery or other drug treatment and administration | — |
Countries
Korea, Republic of
Contacts
Public ContactBeom Jae Lee
Koera University Guro Hospital
Outcome results
None listed