Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

This study is currently recruiting participants.

Verified by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, May 2007

Sponsored by:	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Information provided by:	The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:	NCT00480961

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Procedure: intramiocardiac autograft of autologous stem cells	Phase II

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:

Primary Outcome Measures:

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 Outcome Measures:

Secondary target: determine clinical effects of grafted cells on remodeling pathology. [ Time Frame: 1 YEAR ]

Study Start Date:

May 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480961

Contacts

Contact: cesare scardulla, MD

0912192284

cscardulla@ISMETT.edu

Locations

Italy, Pa
Ismett	Recruiting
PALERMO, Pa, Italy, 90127
Principal Investigator: CESARE SCARDULLA, md

Sponsors and Collaborators

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Investigators

Principal Investigator:

CESARE SCARDULLA, md

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

More Information

Study ID Numbers:	IRRB/00/2006
Study First Received:	May 31, 2007
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00480961
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009