ulcerative colitis ulcerative colitis
Conditions
Interventions
Leukocyte depletion therapy using Immunopure.
Treatment conditions are blood flow rate (QB) of 30 mL/min, total treatment time of 60 minutes, treatment volume of 1800 mL, and the procedure is perform
D007937
Leukapheresis
Sponsors
Shibuya Tomoyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)The participant is over 20 years old and under 80 years old. 2)The participant was diagnosed with ulcerative colitis 3 months before screening. 3) The participant with steroid dependence / resistance / unwished is moderate. 4)The participant provides written informed consent before the commencement of any study related procedure.
Exclusion criteria
Exclusion criteria: 1)The participant is lactating, breastfeeding, or pregnant. 2)The participant has a serious liver disease or heart disease. 3)The participant has a low white blood cell count (less than 3,000 / mm3). 4)The participant has low platelet counts (less than 100,000 / mm3). 5)The participant has a history of hypersensitivity to anticoagulants. 6)The participant is judged to be inappropriate as a participant by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in TNF-alpha levels at the blood outlet of the device before and after the first treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of change in TNF-alpha levels at the blood inlet of the device before and after the first treatment, Safety (adverse events, clinical examination values, vital signs), Remission rate, Effective rate, Change in Lichtiger index score, Change in CRP, and LRG, Removal rate and change in leukocyte and platelet at baseline, 15-min and the end of treatment, and Removal rate and change in inflammatory cytokine at baseline, 15-min and the end of treatment | — |
Contacts
Public ContactTomoyoshi Shibuya
Juntendo University Hospital
Outcome results
None listed