Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00883727

Enrollment

Registered

2009-04-20

Start date

2009-04-30

Completion date

2012-08-31

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

mesenchymal stem cells, myocardial infarction

Brief summary

This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.

Interventions

DRUGStem cell

IV infusion of stem cells

DRUGPlasmalyte A

IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI. * Patient has global left ventricular systolic dysfunction with an ejection fraction of \<50% and \>30%. * 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. * The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery. * Patient with acute myocardial infarction within 10 days prior to IP administration. * Normal liver and renal function. * Able to understand study information provided to him. * Able to give voluntary written consent.

Exclusion criteria

* History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency. * Severe co-morbidity associated with a reduction in life expectancy of less than 1 year. * Advanced renal dysfunction and creatinine ≥ 2mg%. * Advanced hepatic dysfunction. * 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

Design outcomes

Primary

Measure	Time frame
AE and ECG parameters	6 months

Secondary

Measure	Time frame
Regional myocardial perfusion and infarct size	6 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026