Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intramiocardiac autograft of autologous stem cells

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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CESARE SCARDULLA, md

Role: PRINCIPAL_INVESTIGATOR

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Locations

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Ismett

Palermo, pa, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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cesare scardulla, MD

Role: CONTACT

[email protected]

0912192284

Other Identifiers

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IRRB/00/2006

Identifier Type: -

Identifier Source: org_study_id