Clinical trial NCT00114452: Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myocardial Infarction
Keywords: Acute Myocardial Infarction
Heart Attack
Cardiovascular Disease
Stem cells
Congestive Heart Failure
Heart Attack Repair
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
First posted: 2005-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: San Diego
country: United States
facility: University of California - San Diego; Thornton
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist
state: Maryland
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: New York
country: United States
facility: Columbia Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester - Strong Memorial
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart Institute
state: Texas
city: Houston
country: United States
facility: Texas Medical School
state: Texas
Study officials:
affiliation: Mesoblast, Inc.
name: Ken Borow, MD
role: STUDY_DIRECTOR
References:
citation: Orlic D, Hill JM, Arai AE. Stem cells for myocardial regeneration. Circ Res. 2002 Dec 13;91(12):1092-102. doi: 10.1161/01.res.0000046045.00846.b0.
citation: Pittenger MF, Martin BJ. Mesenchymal stem cells and their potential as cardiac therapeutics. Circ Res. 2004 Jul 9;95(1):9-20. doi: 10.1161/01.RES.0000135902.99383.6f.
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. doi: 10.1016/s0003-4975(02)03517-8.
citation: Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055.