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RECRUITING
NCT07822087
PHASE1

A Phase 1 Study of ATORM-C in Patients With Crohn's Disease

Sponsor: ORGANOIDSCIENCES LTD.

View on ClinicalTrials.gov

Summary

This Phase 1 study evaluates the safety and tolerability of ATORM-C in patients with Crohn's disease. ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single dose of ATORM-C applied directly to a target intestinal ulcer during colonoscopy. The study will also explore the effect of ATORM-C on intestinal ulcer healing.

Official title: An Open, Sequential Dose-Escalation, Single-Center, Phase 1 Clinical Trial to Evaluate Tolerability, Safety, and Exploratory Efficacy of ATORM-C in Patients With Crohn's Disease

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-09

Completion Date

2028-08

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous Adult Stem Cell-Derived Intestinal Organoid

ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single administration of ATORM-C applied directly to the target intestinal ulcer during colonoscopy. ATORM-C is administered with fibrin glue (Greenplast-Q) to facilitate local application to the target ulcer.

Locations (1)

Asan Medical Center

Seoul, South Korea