Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Status and phase: Unknown; Phase 2

Conditions: Congestive Heart Failure

Treatments: Procedure: intramiocardiac autograft of autologous stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00480961

IRRB/00/2006

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Age >18 y/o
• CHF with EF > 35%
• Bilirubinemia, serum transaminase> 2.5 times normal max level
• Creatininemia > 2.5 times max level
• NYHA Class > 3
• Negative pregnancy test (for women in fertile age)

Exclusion criteria

• Impossibility to harvest the bone marrow
• Pregnancy or breast-feeding
• History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
• Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)