Importance: Case reports and series suggest @entity8 ( @entity8 ) may benefit some @entity1 with @entity30 . Objective: To evaluate the effect of autologous @entity8 on refractory @entity30 . Design, Setting, and @entity1 : Parallel-group randomized clinical trial conducted in 11 European transplant units from July 2007 to September 2011, with follow-up through March 2013. @entity1 were aged 18 to 50 years with impaired quality of life from refractory @entity30 not amenable to surgery despite treatment with 3 or more immunosuppressive or biologic agents and @entity288 . Interventions: All @entity1 underwent stem cell mobilization before 1:1 randomization to immunoablation and @entity8 (n   =   23) or control treatment ( @entity8 deferred for 1 year [n   =   22]). All were given standard @entity30 treatment as needed. Main Outcomes and Measures: Sustained disease remission at 1 year, a composite primary end point comprising clinical remission ( @entity30 Activity Index (CDAI) <150 [range, 0-600]), no use of @entity288 or immunosuppressive or biologic drugs for at least the last 3 months, and no endoscopic or radiological evidence of @entity66 anywhere in the gastrointestinal (GI) tract. Secondary outcomes were individual components of the primary composite outcome and other measures of disease activity, laboratory results, quality of life and functional status, and GI tract imaging. Results: Twenty-three @entity1 underwent @entity8 and 22 received standard @entity30 treatment (controls). Sustained disease remission was achieved in 2 @entity1 undergoing @entity8 (8.7%) vs 1 control @entity1 (4.5%) (absolute difference, 4.2% [95% CI, -14.2% to 22.6%]; P   =   .60). Fourteen @entity1 undergoing @entity8 (61%) vs 5 control @entity1 (23%) had discontinued immunosuppressive or biologic agents or @entity288 for at least 3 months (difference, 38.1% [95% CI, 9.3% to 59.3%]; P   =   .01). Ten vs 2 @entity1 had a CDAI less than 150 (remission) at the final evaluation, 8 (34.8%) vs 2 (9.1%) for 3 or more months (difference, 25.7% [95% CI, 1.1% to 47.1%]; P   =   .052). Eight (34.8%) vs 2 (9.1%) @entity1 were adjudicated free of active disease on endoscopy and radiology at final assessment (difference, 25.7% [95% CI, 1.1% to 47.1%]; P   =   .054). There were 76 serious adverse events in @entity1 undergoing @entity8 vs 38 in controls. One @entity1 undergoing @entity8 died. Conclusions and Relevance: Among adult @entity1 with refractory @entity30 not amenable to surgery who had impaired quality of life, @entity8 , compared with conventional therapy, did not result in a statistically significant improvement in sustained disease remission at 1 year and was associated with significant @entity137 . These findings do not support the widespread use of @entity8 for @entity1 with refractory @entity30 . Trial Registration: clinicaltrials.gov Identifier:NCT00297193.

Autologous Hematopoetic Stem Cell Transplantation for XXXX : A Randomized Clinical Trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'Participants'] @entity8 :: ('MESH:D007674', 'Disease') :: ['hematopoietic stem cell transplantation', 'HSCT'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity66 :: ('MESH:D004194', 'Disease') :: ['active (erosive) disease'] @entity30 :: ('MESH:D003424', 'Disease') :: ['Crohn disease', 'Crohn Disease'] @entity288 :: ('MESH:D000305', 'Chemical') :: ['corticosteroids']
@entity30 :: (MESH:D003424,Disease) :: ['Refractory Crohn Disease']
