Functional Restoration of Infracted/ Scarred Myocardium Through Transplantation of Bone Marrow Stem Cells: A Clinical Trial

Phase 1

• Conditions: Myocardial Infarction

• Registration Number: CTRI/2010/091/000644
• Lead Sponsor: Global Medical Education and Research Center

Brief Summary

A new experimental strategy for treating patients with myocardial ischemia and left ventricular dysfunction. Regeneration of the myocardium in damaged regions of the myocardial tissue by using ?cardiomyogens? from tissue sources in the formation of cardimyocytes. Bone marrow derived MNCs (CD-34+ and CD-45+ Cells) are used in the therapeutic process.The main aim of this study to perform phase I clinical trial with safety and efficacy and also to evaluate the effect of bone marrow derived MNCs (CD-34+ and CD-45+ Cells) as a clinical therapeutic application in the treatment of ischemic heart disease with diffuse CAD.50 patients with ischemic heart disease with myocardial ischemia and left ventricular dysfunction are screened by SPECT will be subjected to the therapeutic procedure with the direct myocardial injection of autologous bone marrow derived stromal cells (CD-34+ and CD-45+ Cells). Patient monitoring and evaluation is performed for a follow up period of 12 months, in order to identify the effect of the applied clinical therapeutic procedure.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Ages Eligible for Study: >21 Years Genders Eligible for Study: BothAccepts Healthy Volunteers: No?Established cases of MI with ventricular dysfunction graded.?No other associated primary disorder such as pulmonary hypertension.
• ?No associated hematological/infectious diseases.

Exclusion Criteria

• ?Not willing to participate.
• ?No informed consent.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?Improvement in myocardial function observed in SA node, AV node measured by ECG.

Secondary Outcome Measures

Name	Time	Method
?Safety?Improvement in LVEF perfusion measured by ECG, 2D-ECHO, Cardiac MRI, Coronary angiography.?Improved exercise time when observed on the 3rd and 6th month after the therapeutic procedure, when compare to exercise time before the administration of the therapeutic dose.?Improvement in physical activity.?Reduction in the use of medicines.	12 months.

Trial Locations

Locations (1)

Global Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Global Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr.Smita Gheyee

Principal investigator

drsmitagheyee@globalhospital.net