drugset / Trial / NCT02256501

Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy

NCT02256501 ↗

Phase 1/2 Completed 30 enrolled Nasser Aghdami MD., PhD
RandomizedParallel-groupSingle-blindTreatment

Summary

According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in pediatric, new modality of treatment is emerging. There are some case reports of administration of stem cell therapy. The investigators design the first randomized clinical trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16 pts. in each group including cell therapy and control). The investigators assess the safety and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear cells in this patients compared to control group.

Timeline

Start
2013-06
Primary completion
2016-03
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mono Nuclear Cell (MNC) Unknown — Other

Indications