Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial) — RECARDIO  

Chronic Myocardial Ischemia Clinical Trial

Official title: Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial)

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate whether endocavitary intramyocardial injection of autologous bone-marrow-derived CD133+ cells is safe on the basis of number of adverse events, with follow-up assessments extending up to 1 year after enrolment.

Clinical Trial Description

This will be a Phase I study investigating the safety and preliminary efficacy of endocavitary injection of bone-marrow-derived CD133+ cells in 15 patients with ischemic heart failure (IHF) not eligible for conventional revascularization. Patients eligible will undergo bone-marrow aspiration. On the day following bone-marrow aspiration patients will undergo fluoroscopy-based endocavitary intramyocardial injections of the target areas previously identified by gated-SPECT/CMR. CD133+ cells suspended in physiological saline supplemented with 5% human albumin solution will be injected into the myocardium via the endocardial route.

After discharge, efficacy follow-up will last 6-months safety follow-up (FU) will be extended up to 1 year. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Myocardial Ischemia
• Ischemia
• Myocardial Ischemia

• NCT number: NCT02059681
• Study type: Interventional
• Source: Centro Cardiologico Monzino
• Status: Completed
• Phase: Phase 1
• Start date: December 2013
• Completion date: February 2022