Health Condition 1: null- Dilated Cardiomyopathy
Conditions
Interventions
Intervention1: Ex vivo cultured adult allogenic MSCs: Single dose of 2million/kg body weight allogenic MSCs given via intra coronary route.
Control Intervention1: Standard treatment: Usual doses.
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) Timepoint: Baseline, 7th day, 1st month, 3rd month, 6th month, 9th month, 12th month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improvement in left ventricular ejection fraction (LVEF) assessed by Radionuclide imaging and Echocardiography 2) Decrease in LV End Systolic and End Diastolic dimensions and volume assessed by Echocardiography 3) Improvement the quality of Life- SF36 questionnaire 4) Improved in NYHA class 5) Improvement in 6 minutes walk test Timepoint: Baseline, 1st month, 3rd month, 6th month, 9th month, 12th month | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed