Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00480961
• Other study ID #: IRRB/00/2006
• Status: Recruiting
• Phase: Phase 2
• First received: May 31, 2007
• Last updated: May 31, 2007
• Start date: May 2007

Study information

• Verified date: May 2007
• Source: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
• Contact: cesare scardulla, MD
• Phone: 0912192284
• Email: cscardulla[@]ISMETT.edu
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• intramiocardiac autograft of autologous stem cells

Locations

Country	Name	City	State
Italy	Ismett	Palermo	PA

Sponsors (1)

Lead Sponsor	Collaborator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary target: determine clinical effects of grafted cells on remodeling pathology.		1 YEAR