Allogenic mesenchymal stem cells in patients with Dilated Cardiomyopathy
- Conditions
- Health Condition 1: null- Dilated Cardiomyopathy
- Registration Number
- CTRI/2009/091/000437
- Lead Sponsor
- Stempeutics Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 20
1) All subjects must be over age 18 and below 65. 2) Diagnosis of dilated cardiomyopathy according to WHO criteria (Annexure IV). 3) Syndromic heart failure in functional class III or IV of the NYHA in spite of optimal medical treatment for heart failure. 4) Enrollment and continuous follow-up in cardiac out-patient clinic 5) Adequate medical therapy after optimization therapy . 6) Echocardiogram with an ejection fraction equal to or less than 35%. 7) Patients must either be no longer capable of reproduction or taking acceptable measures to prevent reproduction during the study.8) Able to understand study information provided to him/her.9) Able to give voluntary written consent. 10) As per treating doctor?s discretion.
1)Ischemic cardiomyopathy with option for revascularization (Angioplasty/CABG).2) Valvular diseases, except functional mitral or tricuspid reflow. 3) Coronary angiography showing a significant lesion amenable for angioplasty/CABG. 4) Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurysm. 5) Patients who would otherwise qualify for resynchronization therapy (Biventricular pacing). 6) Abusive use of alcohol or illicit drugs. 7) Use of cardio toxic drugs. 8) Any co-morbidity with impact in life expectancy in 2 years.
9) Compromised renal function (serum creatinine above 2 mg/dl). 10) Patients already enrolled in another investigational drug trial. 11) History of alcohol or drug abuse within 3 months of screening. 12) Advanced hepatic dysfunction which increases risk of anaesthesia. 13) Female patients who are pregnant or lactating. 14) Having tested positive for antibodies to HIV, HCV, HBsAg and VDRL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Safety and tolerability, assessed by adverse events. Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, ventricular tachycardia, ventricular fibrillation, pulmonary edema, acute heart failure, unstable angina and major bleeding) <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline, 7th day, 1st month, 3rd month, 6th month, 9th month, 12th month.
- Secondary Outcome Measures
Name Time Method 1)Improvement in left ventricular ejection fraction (LVEF) assessed by Radionuclide imaging and Echocardiography <br/ ><br>2)Decrease in LV End Systolic and End Diastolic dimensions and volume assessed by Echocardiography <br/ ><br>3)Improvement the quality of Life- SF36 questionnaire <br/ ><br>4)Improved in NYHA class <br/ ><br>5)Improvement in 6 minutes walk test <br/ ><br> <br/ ><br>Timepoint: Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>