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

JRCT ID: jRCTb032190207

Registered date:13/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 04/06/2021
• Target sample size: 8
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment

Outcome(s)

• Primary Outcome: Safety: Evaluation of adverse events observed from study entry to 52 weeks after autologous intestinal stem cell transplantation.
• Secondary Outcome: Efficacy: Endoscopic improvement and/or histological improvement

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Okamoto Ryuichi
• Source(s) of Monetary Support: AMED