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Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

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ClinicalTrials.gov Identifier: NCT00480961
Recruitment Status : Unknown
Verified May 2007 by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies.
Recruitment status was:  Recruiting
First Posted : June 1, 2007
Last Update Posted : June 1, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Procedure: intramiocardiac autograft of autologous stem cells Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00480961     History of Changes
Other Study ID Numbers: IRRB/00/2006
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: June 1, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases