A Pilot study on the use of Allogeneic Mesenchymal Stem Cell therapy for Dilated Cardiomyopathy.

Stempeutics Research Pvt Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

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