A clinical study to assess the safety and efficacy of stem cell in patients with Myocardial Infarctio

Phase 1

Completed

Conditions: Health Condition 1: null- ST elevated acute myocardial infarction (STEMI)

Registration Number: CTRI/2009/091/000176

Lead Sponsor: Stempeutics Research Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

a) Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.

b) Patient has global left ventricular systolic dysfunction with an ejection fraction of

<50% and >30%.

c) ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.

d) The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.

e) Patient with acute myocardial infarction within 10 days prior to IP administration.

f) Normal liver and renal function.

g) Able to understand study information provided to him.

h) Able to give voluntary written consent.

Exclusion Criteria

a) History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
b) Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
c) Advanced renal dysfunction and creatinine ≥ 2mg%.
d) Advanced hepatic dysfunction.
e) Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
f) Previous MI.
g) Patients already enrolled in another investigational drug trial.
h) History of severe alcohol or drug abuse within 3 months of screening.
i) Women with child bearing potential or who are pregnant or lactating.
j) Having tested positive for HIV 1, HCV, HBV, syphilis and CMV(IgM).
k) Patients contraindicated for MRI.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary safety end points are: <br/ ><br>1.The type of AE(s),number of AE(s) and proportion of patients with AE(s)2.Assessment of clinical laboratory parameters <br/ ><br>3.Assessment of vital signs <br/ ><br>4.Assessment of electrocardiogram (ECG) parameters <br/ ><br>The primary efficacy endpoint is: <br/ ><br>1.Improvement in left ventricular ejection fraction (LVEF), end systolic volume, and end diastolic volume assessed by echocardiography at the end of 6 months.Timepoint: All primary end points are assessed at the end of 6 months. Subjects are followed for safety reasons for uptil 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary outcome variables: <br/ ><br>The secondary efficacy endpoints are: <br/ ><br>1.Assessment of regional myocardial perfusion by SPECT <br/ ><br>2.Assessment of percentage change in infarct size by MRI <br/ ><br>3.Assessment of regional myocardial function by MRITimepoint: Assessed at the end of 6months