At a glance
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Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
In Brief
A Phase 2 clinical trial evaluating Autologous mesenchymal stem cells for Crohn Disease. Completed, enrolled 15 participants across 3 sites.
Detailed Summary
Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study. Secondary outcome measures: 1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular: * Fistulas healing efficiency * Changes in quality of life in patients treated * Changes of systemic Crohn's disease after implant * Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success. 2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with: * Phenotype study * Suppressor capacity study. * Citoquines production analysis
Study Details
Timeline
Interventions
The trial is divided in three phases: I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature. II.- Treatment phase includes: 1. Liposuction procedure to obtain adipose tissue. 2. Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs) 3. ASCs implant III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant.