Autologous Stem cell Transplantation in Ischaemic Cardiomyopathy with diffuse Coronary Heart Disease.

• Conditions: Coronary Heart disease

• Registration Number: CTRI/2010/091/000626
• Lead Sponsor: Global Medical Education and research centre

Brief Summary

A new experimental strategy for treating myocardial ischemia is to induce neovascularization of the heart using ?angiogens? from tissue sources in the formation of blood vessels. Bone marrow isolated autologous 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 isolated autologous 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 diffuse coronary artery disease are screened by SPECT will be subjected to the therapeutic procedure with the intrarterial infusion of bone marrow isolated autologous MNCs (CD-34+ and CD-45+). 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: NoExternal angina class III ?
• IV.Severe LV systolic dysfunction with EF ≤ 30%Single/Multi vessel coronary artery disease with diffuse atherosclerotic disease neither suitable for (CADGS) bypass grafting nor for percutaneous intervention (PTCA + Stenting).?Hypokinetic, Akinetic, Dyskinetic segments assessed by 16 segments Echo model.

Exclusion Criteria

?LVEF ≤ 31%.?Severe hepatic or renal dysfunction (Co-morbid Medical condition).?Stroke with significant sequel.?HIV/HBS/HCV positive serology.?Short life expectancy due to cancer/ terminal illness which influence the patient.?Mental disorders.?Possibility of non-compliance with the protocol.?Gross CCF/Pulmonary edema.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
?Improvement in LVEF perfusion measured by ECG, 2D-ECHO, Cardiac MRI Coronary angiography.	12 months

Secondary Outcome Measures

Name	Time	Method
?Safety?Improvement in myocardial function observed in SA node, AV node measured by ECG. ?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 (Mild to Moderate), (Rest or Minimal to Mild).?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.Lakshmi Kiran

Principal investigator

lkiran@globalhospital.net