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Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT00480961
First received: May 31, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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
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

No publications provided

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013