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NCT00114452 Clinical Trial

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

Myocardial Infarction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00114452
Other study ID # 401-402
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 22, 2005
Est. completion date April 24, 2008

Study information
Verified date March 2020
Source Mesoblast, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 24, 2008
Est. primary completion date October 4, 2006
Accepts healthy volunteers No
Gender All
Age group 21 Years to 85 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Provacel
ex vivo cultured adult mesenchymal stem cells
• Placebo
Placebo

Locations
Country Name City State
United States Austin Heart Institute Austin Texas
United States Johns Hopkins University Baltimore Maryland
United States Rush University Medical Center Chicago Illinois
United States Texas Medical School Houston Texas
United States The Care Group Indianapolis Indiana
United States Jewish Hospital Louisville Kentucky
United States Minneapolis Heart Institute Minneapolis Minnesota
United States Columbia Presbyterian Hospital New York New York
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States University of Pennsylvania Medical Center Philadelphia Pennsylvania
United States Arizona Heart Institute Phoenix Arizona
United States University of Rochester - Strong Memorial Rochester New York
United States University of California - San Diego; Thornton San Diego California
United States Washington Adventist Takoma Park Maryland
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Mesoblast, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Orlic D, Hill JM, Arai AE. Stem cells for myocardial regeneration. Circ Res. 2002 Dec 13;91(12):1092-102. Review. — View Citation

Pittenger MF, Martin BJ. Mesenchymal stem cells and their potential as cardiac therapeutics. Circ Res. 2004 Jul 9;95(1):9-20. Review. — View Citation

Shake JG, Gruber PJ, Baumgartner WA, Senechal G, Meyers J, Redmond JM, Pittenger MF, Martin BJ. Mesenchymal stem cell implantation in a swine myocardial infarct model: engraftment and functional effects. Ann Thorac Surg. 2002 Jun;73(6):1919-25; discussion 1926. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 months
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