ulcerative colitis
Conditions
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
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced inflammatory activity assessed with endoscopic Mayoscore 14 days after treatment with injection of allogeneic adipose-derived mesenchymal stem cells. | — |
Secondary
| Measure | Time 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