CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Intravenous bone marrow mesenchymal stem cells infusionbiological
Likely dose
Intravenous bone marrow mesenchymal stem cells infusion 3,5 mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01297972
NCT01297972Phase 2Completed
CompareCT.gov

Bone Marrow Mesenchymal Stem Cells in the Treatment of Refractory Severe Acquired Aplastic Anemia

University of Sao Paulo·interventional·Posted Feb 17, 2011·Updated Feb 4, 2014

In Brief

A Phase 2 clinical trial evaluating Intravenous bone marrow mesenchymal stem cells infusion for Aplastic Anemia. Completed, enrolled 9 participants across 1 site.

Detailed Summary

Mesenchymal stem cells have been tested in many autoimmune disorders with encouraging results and may be an alternative to the treatment of immune-mediated severe acquired aplastic anemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAplastic Anemia
CountriesBrazil
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2011
Enrollment StartFeb 1, 2011
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.4 years ago

Interventions

Intravenous bone marrow mesenchymal stem cells infusionbiological

After standard immunosuppressive therapy with rabbit antithymocyte globulin 3,5 mg/Kg/day during 5 days, allogeneic unrelated bone marrow derived mesenchymal stem cells will be infused intravenously. Oral cyclosporine 5 mg/Kg/day (with dose correction weekly to keep serum cyclosporine level between 150-250 mg/dl) up to 6 months will be added.