Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00480961

Enrollment

Unknown

Registered

2007-06-01

Start date

2007-05-31

Completion date

Unknown

Last updated

2007-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

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.

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.

Interventions

PROCEDUREintramiocardiac autograft of autologous stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary target: determine clinical effects of grafted cells on remodeling pathology.	1 YEAR

Countries

Italy

Contacts

Primary Contactcesare scardulla, MD

cscardulla@ISMETT.edu0912192284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026