Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up

NCT ID: NCT00933621

Last Updated: 2009-07-07

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2003-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Ischemic Symptomatic Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autologous Bone Marrow infusion

Percutaneous intracoronary autologous bone marrow infusion

Group Type EXPERIMENTAL

Autologous bone marrow intracoronary infusion

Intervention Type PROCEDURE

Percutaneous intracoronary mononuclear bone marrow cell infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous bone marrow intracoronary infusion

Percutaneous intracoronary mononuclear bone marrow cell infusion

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intracoronary mononuclear bone marrow cell infusion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography

Exclusion Criteria

* Idiopathic or non-ischemic cardiomyopathy
* Other etiology for heart failure, history of past or current disease involving the bone marrow
* Patients on dialysis
* Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Assaf Harofeh MC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alex Blatt, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofeh MC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assaf Harofeh

Ẕerifin, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

Abdel-Latif A, Bolli R, Tleyjeh IM, et al. Adult bone marrow-derived cells for cardiac repair. Arch Intern Med. 2007;167:989-997. 12. Murry CE, Reinecke H and Pabon LM. Regeneration Gaps: Observation on stem cells and cardiac repair. J Am Coll Cardiol. 2006;47:1777-1785.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.