Stem Cell Therapy in Patients With Myocardial Infarction and Persistent Total Occlusion of Infarct Related Artery

Summary

Background: When an acute myocardial infarction occurs, the artery supplying the infarct zone should be opened within twenty four hours of onset of infarction. This has clearly been shown to be beneficial.

If the patient presents later than 24 hours of onset, at that stage a large part of the damage to the heart is irreversible. Intervening at this stage (beyond 24 hours is controversial). Some trials suggest that opening the artery even at this stage positively modifies the remodeling process while other trials suggest that such a benefit is not seen.

Hypothesis: Opening an infarct related artery after 24 hours (until 6 months) and combining it with intracoronary stem cell therapy may provide incremental benefit.It is possible that the lack of benefit seen with late revascularization (\>24 hrs) after MI may be offset by giving intracoronary stem cells after opening the artery.

Conditions

• Acute Myocardial Infarction

Interventions

PROCEDURE

Intracoronary stem cells injection

Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting autologous bone marrow stem cells from iliac crest 60 ml bone marrow will be extracted and purified for mononuclear cells which will be injected.

PROCEDURE

coronary dilatation and stenting

coronary dilatation and stenting

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Sandeep Seth, DM · All India Institute of Medical Sciences

• Balram Airan, DM · All India Institute of Medical Sciences

• V K Bahl, DM · AIIMS, New Delhi

• Balram Bhargava, DM · AIIMS, New Delhi

• Chetan Patel · AIIMS, New Delhi

• Sujata Mohanty · AIIMS, New Delhi

• Rajiv Narang, DM · AIIMS, New Delhi

• S Ramakrishnan, DM · AIIMS, New Delhi

• K C Goswami, DM · AIIMS, New Delhi

• Rakesh Yadav, DM · AIIMS, New Delhi

• Ambuj Roy, DM · AIIMS, New Delhi

• G Karthikeyan, DM · AIIMS, New Delhi

• Gautam Sharma, DM · AIIMS, New Delhi

• Sandeep Singh, DM · AIIMS, New Delhi

• Sandeep Mishra, DM · AIIMS, New Delhi

• Nitish Naik, DM · AIIMS, New Delhi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2014-06-30

Completion

2014-09-30

Countries

• India

Study Locations