Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
Phase 2
- Conditions
- Congestive Heart Failure
- Registration Number
- NCT00480961
- Lead Sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 1 YEAR
- Secondary Outcome Measures
Name Time Method Secondary target: determine clinical effects of grafted cells on remodeling pathology. 1 YEAR
Trial Locations
- Locations (1)
Ismett
🇮🇹Palermo, PA, Italy