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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00114452

Enrollment

Registered

2005-06-15

Start date

2005-03-22

Completion date

2008-04-24

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Acute Myocardial Infarction, Heart Attack, Cardiovascular Disease, Stem cells, Congestive Heart Failure, Heart Attack Repair

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.

Interventions

BIOLOGICALProvacel

ex vivo cultured adult mesenchymal stem cells

BIOLOGICALPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026