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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030117

Enrollment

Registered

2018-04-01

Start date

2018-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

Autologous intestinal stem cell transplantation (Single-dose)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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), and anti-TNF antibodies (infliximab, adalimumab, golimumab). (5) Sustained colonic ulcer (over 5mm diameter) confirmed by colonoscopy performed within 4-weeks from study entry.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety: Evaluation of adverse events observed from study entry to 52 weeks after autologous intestinal stem cell transplantation.	—

Countries

Japan

Contacts

Public ContactRyuichi Okamoto

Tokyo Medical and Dental University Center for Stem Cell and Regenerative Medicine

rokamoto.gast@tmd.ac.jp03-3813-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026