Cure8 trial brief
Why This Matters
A new Phase 2 trial is testing whether intravenous allogeneic HB-adMSCs can improve Crohn’s symptoms and intestinal inflammation. If effective and safe, the therapy could offer a different mechanism of treatment from current biologics or small molecules.
Who Should Pay Attention
Adults with Crohn's disease, clinicians and researchers interested in stem-cell or cell‑therapy approaches, and patients following experimental therapies.
Study Snapshot
What To Know
This trial is interventional and currently recruiting at a single site (Hope Biosciences Research Foundation, Sugar Land, Texas). Approximately 46 participants will be randomized 1:1 to HB-adMSCs or placebo, with a 16‑week treatment period and safety/efficacy follow-up through week 52.
The primary endpoint is change in CDAI; a ≥100‑point decrease is defined in the record as the minimal clinically important difference. The study excludes people with certain uncontrolled medical conditions, active malignancy, recent investigational therapies, or active viral hepatitis/HIV, among other criteria.
Fecal calprotectin and standard lab tests are specified as secondary outcomes and safety monitoring. This summary is based on the ClinicalTrials.gov record (NCT07077746) and describes the trial registration details, not results.
Keep In Mind
This is a trial registration record (Phase 2, recruiting) and does not report efficacy or safety results. Details such as dosing schedule and full outcome measures are available in the full trial record; participants must meet listed inclusion/exclusion criteria.
Source Details
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.