2024-518643-38-00CompletedPhase 1/2
Adipose-derived mesenchymal stem cells as local treatment of ulcerative colitis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 22 Oct 2024
- Start date
- 30 Jun 2023
- Lead sponsor
- Region Midtjylland
- Diseases
- Ulcerative colitis
- EU CT number
- 2024-518643-38-00
- EudraCT number
- 2022-002325-99
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 16
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland | Aarhus N | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.