Cure8 trial brief
This trial tests a novel, tissue-derived cell therapy applied directly to intestinal ulcers — an approach that could lead to new local healing treatments for people with Crohn’s disease if proven safe and effective.
For patients with ulcers not healing on standard therapy, a targeted organoid application may become a future option pending later-phase trial results.
Adults with Crohn’s disease (especially those with persistent intestinal ulcers despite standard treatment), clinicians who perform IBD endoscopy or manage refractory Crohn’s, and researchers in cell therapy/organoid therapeutics.
This is a Phase 1, open-label, dose-escalation study testing ATORM-C — an autologous adult stem cell–derived intestinal organoid product — in adults with Crohn’s disease.
Participants will have intestinal tissue harvested to grow organoids, then receive a single local application of ATORM-C (with fibrin glue) directly to a target intestinal ulcer during colonoscopy.
The trial’s primary focus is safety/tolerability (dose-limiting toxicities, MTD/RP2D) with exploratory assessment of ulcer healing; planned enrollment is 18 across three escalating dose levels. The protocol excludes patients who need surgery, have active abscesses or fistulas, recent bowel resection, prior cell therapy, or certain lab abnormalities.
Key practical points: treatment is autologous (derived from each participant), administered endoscopically to a defined ulcer, and monitored for adverse events up to at least 24 weeks for dose-finding assessments.
This summary is grounded in the ClinicalTrials.gov record (trial NCT07822087) and describes the registered study design and interventions; it does not report results or imply efficacy.
This is an early Phase 1 study focused on safety and dose-finding with a small planned enrollment (18). Being registered and currently recruiting does not mean benefit has been demonstrated; outcomes are exploratory and the product is investigational. The record is a trial registry entry (ClinicalTrials.gov) rather than a peer-reviewed report.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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