RecruitingPhase 1NCT07822087

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

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


Sponsor

ORGANOIDSCIENCES LTD.

Enrollment

18 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Autologous Adult Stem Cell-Derived Intestinal Organoid for people with crohn's disease and crohn's diseases. The study is currently recruiting participants at 1 location. People eligible for this study include aged 19 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous 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

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NCT07822087


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