NCT00480961

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

June 1, 2007

Status Verified

May 1, 2007

First QC Date

May 31, 2007

Last Update Submit

May 31, 2007

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (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.

    1 YEAR

Secondary Outcomes (1)

  • Secondary target: determine clinical effects of grafted cells on remodeling pathology.

    1 YEAR

Interventions

intramiocardiac autograft of autologous stem cellsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ismett

Palermo, pa, 90127, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • CESARE SCARDULLA, md

    The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

cesare scardulla, MD

CONTACT

0912192284cscardulla@ISMETT.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 1, 2007

Study Start

May 1, 2007

Last Updated

June 1, 2007

Record last verified: 2007-05

Locations

IT(1)