NCT00883727

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1.1 years

First QC Date

April 17, 2009

Last Update Submit

March 4, 2013

Conditions

Myocardial Infarction

Keywords

mesenchymal stem cellsmyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • AE and ECG parameters

    6 months

Secondary Outcomes (1)

  • Regional myocardial perfusion and infarct size

    6 months

Study Arms (2)

stem cells

EXPERIMENTAL
Drug: Stem cell

Placebo

PLACEBO COMPARATOR
Drug: Plasmalyte A

Interventions

Stem cellDRUG

IV infusion of stem cells

stem cells
Plasmalyte ADRUG

IV infusion

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Care Hospital

Hyderabad, Andhra Pradesh, 500034, India

Location

SAL Hospital and Medical Institute

Ahmedabad, Gujarat, 380054, India

Location

MS Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

Bhagawan Mahaveer Jain Heart Centre

Bangalore, Karnataka, 5660052, India

Location

Related Publications (1)

  • Chullikana A, Majumdar AS, Gottipamula S, Krishnamurthy S, Kumar AS, Prakash VS, Gupta PK. Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction. Cytotherapy. 2015 Mar;17(3):250-61. doi: 10.1016/j.jcyt.2014.10.009. Epub 2014 Dec 4.

    PMID: 25484310DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Sreenivas Kumar, MD, DM

    Care Hospital, Hyderabad

    PRINCIPAL INVESTIGATOR

  • Satya Gupta

    SAL Hospital, Ahmedabad

    PRINCIPAL INVESTIGATOR

  • R Keshava, MD, DM

    Bhagwan Mahaveer JAin Hospital, Bangalore

    PRINCIPAL INVESTIGATOR

  • Prakash VS, MD., DM

    MS Ramaiah Memorial Hospital, Bangalore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2010

Study Completion

August 1, 2012

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

IN(4)