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OpenTrials
Completed

NCT Number: NCT00114452

Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction

The purpose of the study is to determine whether adult stem cells [Provacel™(PUMP1)] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Heart Institute, Phoenix, Arizona, United States

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About this study

Cardiovascular disease is the single largest killer of males and females in the United States with an average of 335,000 deaths per year. This year an estimated 700,000 Americans will suffer an acute myocardial infarction. The standard of care treatment for acute myocardial infarction (MI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. Management of cardiac risk factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and exercise all work to reduce further atherosclerotic events. Yet, many patients go on to develop Congestive Heart Failure (CHF). Medical management for CHF may improve symptoms and slow the progression to failure but does not restore a functioning myocardium. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit in an area of unmet medical need.

Patients will receive standard of care in addition to stem cells or placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female between 21 and 85 years old
  • First heart attack within 1 to 10 days

Exclusion criteria

  • Positive for HIV 1 and 2
  • Previous heart attack
  • Pacemaker or other device
  • Pregnant or breastfeeding
  • Allergic to cow or pig derived products
  • Previous bone marrow transplant
  • Involved in another clinical trial within the past 30 days
  • Alcohol or recreational drug abuse within the past 6 months
  • Hepatitis Positive
  • Major surgical procedure or major trauma within the past 14 days
  • Body weight greater than 300 pounds
  • Autoimmune disease ( e.g. Lupus, Multiple Sclerosis)

Treatment and study plan

Provacel

Biological

ex vivo cultured adult mesenchymal stem cells

Placebo

Biological

Placebo

Primary outcomes

  1. Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mesoblast, Inc.

Industry

Registry information

Official study title

A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose Escalation, Multicenter Study to Determine the Safety of Intravenous Ex-vivo Cultured Adult Human Mesenchymal Stem Cells (Provacel) Following Acute Myocardial Infarction

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Jun 15, 2005
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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