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Befejeződött1/2. fázis

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

Key facts

Where
Aarhus N, DániaSee the site
Phase
1/2. fázis

Where in Dánia

  • Region MidtjyllandAarhus N, DániaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Region Midtjylland
Trial code
EU 2024-518643-38-00
Record updated
2024. november 11.
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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: Severe disease activity assessed on the Mayoscore (score > 10); Disease spread proximal to the left flexure (extensive colitis); Active malignant disease; People allergic to penicillin (the final product contains traces of penicillin); Acute severe colitis according to the Truelove-Witt criteria; Pregnancy (checked with pregnancy test (urine HCG), if fertile woman); Smoker (defined as smoking cessation < 12 weeks); Fertile women who do not use very safe contraception (defined as birth control pills, IUDs or sexual abstinence) or are sterilized.

EU CTIS 2024-518643-38-00