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
1 other identifier
interventional
60
1 country
15
Brief Summary
The purpose of the study is to determine whether adult stem cells \[Provacelâ„¢(PUMP1)\] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2005
Typical duration for phase_1
15 active sites
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
March 22, 2005
CompletedFirst Submitted
Initial submission to the registry
June 14, 2005
CompletedFirst Posted
Study publicly available on registry
June 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2008
CompletedMarch 10, 2020
March 1, 2020
1.5 years
June 14, 2005
March 6, 2020
Conditions
Keywords
Outcome Measures
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.
6 months
Study Arms (5)
Provacel: Cohort 1
ACTIVE COMPARATORex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 2
ACTIVE COMPARATORex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 3
ACTIVE COMPARATORex vivo cultured adult mesenchymal stem cells
Provacel: Cohort 4
ACTIVE COMPARATORex vivo cultured adult mesenchymal stem cells
Placebo
PLACEBO COMPARATORex vivo cultured adult mesenchymal stem cells
Interventions
Eligibility Criteria
You may qualify if:
- Male or female between 21 and 85 years old
- First heart attack within 1 to 10 days
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
Study Sites (15)
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
University of California - San Diego; Thornton
San Diego, California, 92103-8411, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The Care Group
Indianapolis, Indiana, 46260, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Washington Adventist
Takoma Park, Maryland, 20912, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Columbia Presbyterian Hospital
New York, New York, 10032, United States
University of Rochester - Strong Memorial
Rochester, New York, 14642, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Austin Heart Institute
Austin, Texas, 78756, United States
Texas Medical School
Houston, Texas, 77030, United States
Related Publications (4)
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.
PMID: 12480809BACKGROUNDPittenger 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.
PMID: 15242981BACKGROUNDShake 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.
PMID: 12078791BACKGROUNDHare 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.
PMID: 19958962DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ken Borow, MD
Mesoblast, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2005
First Posted
June 15, 2005
Study Start
March 22, 2005
Primary Completion
October 4, 2006
Study Completion
April 24, 2008
Last Updated
March 10, 2020
Record last verified: 2020-03