Adipose-derived mesenchymal stem cells as local treatment of ulcerative colitis
- Conditions
- ulcerative colitis
- Registration Number
- 2024-518643-38-00
- Lead Sponsor
- Region Midtjylland
- Brief Summary
To investigate treatment with injection of allogeneic adipose-derived mesenchymal stem cells locally in the mucosa of patients with ulcerative colitis (UC) reduces the degree of mucosal inflammation and intestinal symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Age 18-70 years
Known ulcerative colitis with spread limited to the left side of the colon
Mild-moderate activity in UC assessed by complete Mayoscore > 2 and < 10
Speaks and understands Danish
Fully informed consent
Severe disease activity assessed on the Mayoscore (score > 10)
Acute severe colitis according to the Truelove-Witt criteria
Disease spread proximal to the left flexure (extensive colitis)
Active malignant disease
Pregnancy (checked with pregnancy test (urine HCG), if fertile woman)
Smoker (defined as smoking cessation < 12 weeks)
People allergic to penicillin (the final product contains traces of penicillin)
Fertile women who do not use very safe contraception (defined as birth control pills, IUDs or sexual abstinence) or are sterilized
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells. Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells.
- Secondary Outcome Measures
Name Time Method Reduced inflammatory activity assessed with endoscopic Mayoscore 4, 7, 14 and 30 days after treatment. Reduced inflammatory activity assessed with endoscopic Mayoscore 4, 7, 14 and 30 days after treatment.
Improvement in histological grading of inflammation in tissue samples day 4, 7, 14 and 30 after treatment. Improvement in histological grading of inflammation in tissue samples day 4, 7, 14 and 30 after treatment.
Improvement in symptoms 4, 7, 14 and 30 days after treatment assessed by complete Mayoscore Improvement in symptoms 4, 7, 14 and 30 days after treatment assessed by complete Mayoscore
Complications/adverse events during the treatment in relation to dose seeking Complications/adverse events during the treatment in relation to dose seeking
Demonstrate the formation or absence of HLA antibodies, corresponding to the donor's HLA type, as a result of the treatment. Demonstrate the formation or absence of HLA antibodies, corresponding to the donor's HLA type, as a result of the treatment.
Demonstrate differences between the ability of mesenchymal stem cells from different donors to immunomodulation using potency assays. Demonstrate differences between the ability of mesenchymal stem cells from different donors to immunomodulation using potency assays.
Trial Locations
- Locations (1)
Region Midtjylland
🇩🇰Aarhus N, Denmark
Region Midtjylland🇩🇰Aarhus N, DenmarkAnders DigeSite contact51903619andedige@rm.dk