NCT02059681

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Myocardial Ischemia

Interventions

Type	Name	Description
OTHER	Autologous bone marrow derived-CD133+ cells	Cell therapy

Timeline

• Start date: 2013-12-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2014-02-11
• Last updated: 2022-03-22

Locations

3 sites across 1 country: Italy