Mucosal regeneration therapy by autologous intestinal stem cell transplantation to inflammatory bowel disease patients. - Intestinal stem cell transplantation for inflammatory bowel disease.

Okamoto Ryuichi0 个研究点目标入组 8 人开始时间: 2020年2月13日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1) Acquirement of patient-signed formal approvement at study entry.
•(2) Age over 20 at study entry.
•(3) Satisfy the diagnostic criteria for ulcerative colitis.
•(4) Limited clinical efficacy, reduction of efficacy or intolerance to the following drugs: Corticosteroids, Immunomodulators (tacrolimus, azathioprine, 6-mercaptopurine), anti-TNF antibodies (infliximab, adalimumab, golimumab), tofacitinib, vedolizumab, and ustekinumab.
•(5) Sustained colonic ulcer (over 5mm diameter) confirmed by colonoscopy performed within 4-weeks from study entry.

•(1) Past history of colectomy.
•(2) Planning or awaiting colectomy.
•(3) Satisfies contraindication criteria for colonoscopy.
•(4) Failure to confirm the presence of sustained colonic ulcer (over 5mm diameter) by colonoscopy performed within 4-weeks from study entry.
•(5) Presence of gastrointestinal dysplasia.
•(6) Complication of colitis other than ulcerative colitis.
•(7) Failure to confirm the presence of un-inflamed region by colonoscopy performed within 4-weeks from study entry.
•(8) Positive results for HHV6 and/or HHV7 infection acquired from colonic mucosal biopsies taken during the colonoscopy performed within 4-weeks from study entry.
•(9) Presence of active infection.
•(10) Poor general condition.
•(11) Past history or suspected presence of malignancy within 5 years from study entry.
•(12) Having difficulty in making self-decision due to diseases such as dementia.
•(13) Pregnant or lactating women, including suspected pregnancy or those anticipating pregnancy.
•(14) Allergy against Neoveil or Beriplast.
•(15) Allergy against aprotinin, thrombin, fibrinogen, or polyglycolic acid.
•(16) Allergy against penicillin, gentamycin or streptomycin.
•(17) Under treatment with antithrombotic drugs.
•(18) Under treatment either with hemocoagulase, epsilon aminocaproic acid, tranexamic acid, or aprotinin.
•(19) Recommended to be excluded by the study director or other study members.

发起方

Okamoto Ryuichi