ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This trial is testing whether adding vedolizumab after autologous stem cell transplant can improve remission rates for people with severe Crohn's disease that has failed multiple therapies.
For patients with refractory disease and limited surgical options, investigational approaches like HCT aim to reset the immune system and then use biologic maintenance to sustain remission.
Who Should Pay Attention
Adults with severe, treatment-refractory Crohn's disease (including those who have failed corticosteroids, immunomodulators, anti-TNF agents, anti-integrin agents, or ustekinumab), IBD clinicians considering advanced therapies, and researchers studying cellular therapies or biologic maintenance strategies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 2
Enrollment50 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov record for a Phase 2 interventional study testing autologous hematopoietic stem cell transplantation (HCT) followed by maintenance vedolizumab in adults with active, treatment-refractory Crohn's disease.
Eligible patients undergo baseline endoscopy/colonoscopic and MR/CT enterography confirmation of active mucosal disease, stem cell mobilization and collection, high-dose chemotherapy with transplant hospitalization, then vedolizumab maintenance dosing (standard 0, 2, 6 weeks then every 8 weeks) for a planned eight doses.
Primary outcomes include change in CDAI and proportion in clinical remission at 1 year post-transplant.
Keep In Mind
This is a registered Phase 2 trial (recruiting). As a trial-record summary, the description reflects the study design and planned interventions rather than results. Autologous HCT involves intensive chemotherapy, hospitalization, and important risks; eligibility requires failure of multiple prior therapies and lack of surgical options.
Participation decisions should be made with specialist consultation.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorAaron Etra
Trial IDNCT03219359
Study typeInterventional
Trial phasePhase 2
Enrollment50 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 24, 2026, 12:00 AM
Content availableTrial registry record
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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