Skip to content

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518643-38-00
Enrollment
16
Registered
2024-11-11
Start date
2023-06-30
Completion date
2025-10-22
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Brief summary

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

Detailed description

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., Demonstrate differences between the ability of mesenchymal stem cells from different donors to immunomodulation using potency assays.

Interventions

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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., Demonstrate differences between the ability of mesenchymal stem cells from different donors to immunomodulation using potency assays.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026