Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

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

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-12-31

Brief Summary

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

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

NCT00743639

Dilated Cardiomyopathy

COMPLETED PHASE2/PHASE3

Cell Therapy in Dilated Cardiomyopathy: Observational Study

NCT00612911

Cardiomyopathy, Dilated

TERMINATED

Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy

NCT00629096

Dilated Cardiomyopathy

COMPLETED PHASE2

Progenitor Cell Therapy in Dilative Cardiomyopathy

NCT00284713

Heart Failure, Congestive Cardiomyopathy, Dilated Stem Cell Transplantation

COMPLETED PHASE1/PHASE2

Cell Therapy in Patients With Chronic Ischemic Heart Disease Undergoing Cardiac Surgery

NCT01267331

Old Myocardial Infarction Chronic Myocardial Ischemia Left Ventricular Dysfunction

UNKNOWN PHASE1/PHASE2

Detailed Description

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

Conditions

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

Dilated Cardiomyopathy

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

intramyocardial bone marrow stem cells implantation

Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
* left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
* age below 60 years
* absence of neoplasm
* absence of hematologic disease or systemic disease
* no previous cardiac intervention