Crohn'
Conditions
Interventions
Low dose group: 1,000,000 cells/kg (day 0 and day 7) DIV. High dose group: 4,000,000 cells/kg (day 0 and day 7) DIV. Safety in high dose group will be evaluated after confirmation of safety in 3 cas
Sponsors
Hokkaido University
Hyogo Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20-69. 2. Diagnosed as definitive Crohn's disease more than 24 weeks before registration. 3. Resistant or not tolerable to at least 2 biological products (Infliximab, Adalimumab, and Ustekinumab). 4. CDAI 200-450 5. Main lesion observed at ileum end or colorectum. 6. Patients who voluntarily signed the Institutional Review Board approved written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with fistula with uncontrollable abscess. (2) Patients with a history of total or subtotal colectomy. (3) Patients with a history of small intestinal resection or short bowel syndrome. (4) Patients with stoma, internal fistula or severe intestinal stricture. (5) Patients who underwent surgery within 4 weeks before informed consent. (6) Patients with a history of cancer in 5 years. (7) Patients who received any medicine or treatment not allowed certain period before registration, and other medicine or treatment for clinical trials, and patients who received any medicine or treatment not allowed to start, stop or change the dose. (8) Patients with uncontorollable systemic disease. (9) Laboratory tests within these ranges 1) Hemoglobin <8.0 g/dL 2) White blood cell count <3,000/microliter 3) Lymphocyte count <500 microliter 4) AST >3x upper limit 5) ALT >3x upper limit 6) Total bilirubin >2.0 mg/dL 7) Serum creatinine >2x upper limit (10) Patients who can not keep SpO2 of >94% (11) Patients positive for HIV-Ab, HTLV-1-Ab, HBs Ag, HCV-Ab. (12) Patients with uncontrollable severe infectious disease. (13) Patients with severe hypersensitivity to bovine-derived constituents, human serum albumin and gentamicin. (14) Patients with cancer, dysplasia or adenomatous polyp which needs to be treated in the colorectum. (15) Patients with a history of hypersensitivity to iodine or iodine-containing contrast agent. (16) Patients who had underwent any other treatment with cell therapy product. (17) Patients with a history of any severe neurological disorder. (18) Patients in pregnancy or breast-feeding, patients who want to be pregnant, patients who can not prevent conception. (19) Patients considered as ineligible to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events related to acute infusion toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events in 52 weeks after first administration of MSCs. Defects of investigational products. CDAI, SESCD and IBDQ 4 weeks after first administration of MSCs and their time-course change up to 52 weeks. Infiltration of macrophages and neutrophils in the inflamed tissue. Serum levels of inflammatory markers (TNF-a, MCP-1, IL-1b, IL-10, MIF). | — |
Countries
Japan
Contacts
Public ContactShunsuke Ohnishi
Hokkaido University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed