Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Locations
- 1
- Primary Endpoint
- Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
- Last Updated
- 18 years ago
Overview
Brief Summary
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.
Detailed Description
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.
Time Frame: 1 YEAR
Secondary Outcomes
- Secondary target: determine clinical effects of grafted cells on remodeling pathology.(1 YEAR)