Cure8 trial brief
This trial is testing a novel stem-cell infusion approach aimed at treating Crohn’s disease and ulcerative colitis, so people with IBD may be interested in emerging cell-therapy options and safety data. Phase 1 studies focus on safety and tolerability, which can help determine whether larger trials are warranted.
If you have active infection, cancer, pregnancy, or other excluded conditions, you would not be eligible for this study based on the registry criteria.
Adults with Crohn’s disease or ulcerative colitis interested in experimental cell therapies; clinicians and researchers following regenerative-medicine approaches for IBD; patients considering clinical trial participation.
This is a Phase 1 interventional clinical trial (NCT05003947) testing a single intravenous infusion of cultured allogeneic adult umbilical cord or placental-derived mesenchymal stem cells for people with Crohn’s disease or ulcerative colitis.
Planned enrollment is 15; participants will be followed for safety and efficacy up to 48 months with monitoring for adverse events. Eligibility excludes active infection, active cancer, pregnancy, and other serious health issues. The record focuses on safety as the primary outcome (adverse events) with long-term follow-up.
The intervention is described as a single IV infusion of allogeneic mesenchymal stem cells sourced from adult umbilical cord or placenta; the trial is recruiting at two locations (Naples, FL, USA and Athens, Greece).
This brief summarizes the clinicaltrials.gov record (trial registry information) and does not represent review of any full trial results or external peer-reviewed publications.
This entry is a clinicaltrials.gov trial record (Phase 1, recruiting) and reports planned study design and eligibility; it does not provide trial results. Phase 1 studies are primarily designed to assess safety in a small number of participants and are not evidence of clinical benefit.
Recruitment locations and inclusion/exclusion criteria are listed in the registry; consult the trial contact or your clinician for enrollment questions.
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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