Adipose-derived mesenchymal stem cells as local treatment of ulcerative colitis

Region Midtjylland1 site in 1 country16 target enrollmentNovember 11, 2024

DrugsMSC, adipose tissue, MSC, adipose tissue, MSC, adipose tissue, MSC, adipose tissue Natriumklorid ”B. Braun”, Natriumklorid Fresenius Kabi 9 mg/ml Natriumklorid Fresenius Kabi 9 mg/ml Natriumklorid ”B. Braun”Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue MSC, adipose tissue

Overview

Phase: Phase 1/2
Intervention: Not specified
Conditions: Not specified
Sponsor: Region Midtjylland
Enrollment: 16
Locations: 1
Primary Endpoint: Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

euclinicaltrials.eu

Start Date

November 11, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Region Midtjylland

Responsible Party

Principal Investigator

Klaus Krogh

Scientific

Region Midtjylland

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells.

Secondary Outcomes

Demonstrate differences between the ability of mesenchymal stem cells from different donors to immunomodulation using potency assays.
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 symptoms 4, 7, 14 and 30 days after treatment assessed by complete Mayoscore
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.