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Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Prochymal®
Placebo
Sponsored by
Mesoblast, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction, AMI, Myocardial infarction, Heart attack, Mesenchymal stem cells, MSC, Adult human stem cells, Osiris

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female between 21 and 85 years old, inclusive
  • First heart attack within 7 days prior to randomization and drug infusion
  • Baseline left ventricular ejection fraction (LVEF) 20-45%
  • Hemodynamically stable within 24 hours prior to randomization
  • Adequate pulmonary function

Exclusion Criteria:

  • Previous medical history of heart attack, heart failure, significant valvular heart disease, aortic dissection
  • Pacemaker or other device
  • Pregnant, breast-feeding, or intends to become pregnant during the study
  • Allergy to cow or pig derived products
  • Evidence of active malignancy or prior history of active malignancy
  • Major surgical procedure or major trauma within the past 14 days
  • Autoimmune disease (e.g., Lupus, Multiple Sclerosis)
  • Any medical condition, which in the opinion of the Investigator, renders participation unsuitable
  • Undergone pharmacologic cardioversion or external defibrillation within 24 hours of randomization.
  • Experienced cardiac arrest more than 36 hours after presentation to site or within 24 hours of randomization.

Sites / Locations

  • Mercy Gilbert Medical Center / Catholic Health Care West
  • University of Arizona
  • UC Davis Medical Center
  • University of California - San Diego (UCSD)
  • Mount Sinai Medical Center
  • University of Miami
  • Rush University Medical Center
  • The Care Group
  • University of Iowa Hospitals and Clinics
  • Cotton-O'Neil Clinical Research Center
  • University of Maryland Hospital
  • Tufts Medical Center
  • Baystate Medical Center
  • UMass Memorial Medical Center
  • William Beaumont Hospital
  • Michigan Cardiovascular Institute
  • Minneapolis Heart Institute
  • UMDNJ - Robert Wood Johnson Medical School
  • University at Buffalo - Buffalo General Hospital
  • Stony Brook University Medical Center
  • Wake Forest University School of Medicine
  • The Lindner Research Center
  • The Ohio State University Medical Center
  • Oregon Health & Science University
  • Penn State University - Milton S. Hershey Medical Center
  • Drexel University College of Medicine
  • Allegheny General Hospital
  • The Stern Cardiovascular Center
  • Austin Heart P.A.
  • University of Texas Health Science Center
  • Fletcher Allen Health Care
  • University of Wisconsin School of Medicine
  • McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prochymal®

Placebo

Arm Description

Participants will receive Prochymal® single intravenous (IV) infusion at a dose of 200 x 10^6 human mesenchymal stem cells (hMSC), reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.

Participants will receive Prochymal® placebo-matching single IV infusion at a dose of of 200 x 10^6 hMSC, reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.

Outcomes

Primary Outcome Measures

Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3

Secondary Outcome Measures

Left Ventricular End Systolic Volume
Infarct Size
Left Ventricular Ejection Fraction
Left Ventricular End Diastolic Volume
Number of Participants with Ventricular Arrhythmias
Duke Activity Status Index (DASI) Assessment
The Duke Activity Status Index (DASI) is a brief, self-administered questionnaire that provides a standardized assessment of functional status and quality-of-life that correlates well with an objective measure of maximal exercise capacity. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores indicate a greater ability to perform daily activities.
New York Heart Association (NYHA) Congestive Heart Failure Classification Status
Maximal Symptom-limited Exercise Test (Treadmill)
Number of Participants with Major Adverse Cardiac Events (MACE)
Overall Survival
Number of Participants with Adverse Events

Full Information

First Posted
April 7, 2009
Last Updated
January 11, 2022
Sponsor
Mesoblast, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00877903
Brief Title
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
Official Title
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 30, 2009 (Actual)
Primary Completion Date
May 18, 2011 (Actual)
Study Completion Date
March 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mesoblast, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Detailed Description
The standard of care treatment for acute myocardial infarction (AMI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. However, because salvaging the viable myocardium is dependent on early reperfusion, only a minority of participants will reach the hospital within the time-window for myocardial rescue. Thus, even if the participant manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many participants will go on to develop Congestive Heart Failure (CHF). Though the medical management for CHF may improve symptoms and slow disease progression, such treatment cannot 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. The characteristics and biologic activity of Prochymal®, along with a good safety profile in human trials to date, suggest that Prochymal® may be a good candidate for addressing this unmet medical need.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Acute myocardial infarction, AMI, Myocardial infarction, Heart attack, Mesenchymal stem cells, MSC, Adult human stem cells, Osiris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prochymal®
Arm Type
Experimental
Arm Description
Participants will receive Prochymal® single intravenous (IV) infusion at a dose of 200 x 10^6 human mesenchymal stem cells (hMSC), reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Prochymal® placebo-matching single IV infusion at a dose of of 200 x 10^6 hMSC, reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.
Intervention Type
Drug
Intervention Name(s)
Prochymal®
Other Intervention Name(s)
Remestemcel-L
Intervention Description
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous infusion of excipients of Prochymal®
Primary Outcome Measure Information:
Title
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
Time Frame
Baseline, Month 3
Secondary Outcome Measure Information:
Title
Left Ventricular End Systolic Volume
Time Frame
6 months
Title
Infarct Size
Time Frame
3 and 6 months
Title
Left Ventricular Ejection Fraction
Time Frame
3 and 6 months
Title
Left Ventricular End Diastolic Volume
Time Frame
3 and 6 months
Title
Number of Participants with Ventricular Arrhythmias
Time Frame
3 and 6 months
Title
Duke Activity Status Index (DASI) Assessment
Description
The Duke Activity Status Index (DASI) is a brief, self-administered questionnaire that provides a standardized assessment of functional status and quality-of-life that correlates well with an objective measure of maximal exercise capacity. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores indicate a greater ability to perform daily activities.
Time Frame
6, 12, and 24 months
Title
New York Heart Association (NYHA) Congestive Heart Failure Classification Status
Time Frame
6, 12, 24, and 60 months
Title
Maximal Symptom-limited Exercise Test (Treadmill)
Time Frame
6 and 12 months
Title
Number of Participants with Major Adverse Cardiac Events (MACE)
Time Frame
6, 12, 24, and 60 months
Title
Overall Survival
Time Frame
60 months
Title
Number of Participants with Adverse Events
Time Frame
3,6,12,24,60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female between 21 and 85 years old, inclusive First heart attack within 7 days prior to randomization and drug infusion Baseline left ventricular ejection fraction (LVEF) 20-45% Hemodynamically stable within 24 hours prior to randomization Adequate pulmonary function Exclusion Criteria: Previous medical history of heart attack, heart failure, significant valvular heart disease, aortic dissection Pacemaker or other device Pregnant, breast-feeding, or intends to become pregnant during the study Allergy to cow or pig derived products Evidence of active malignancy or prior history of active malignancy Major surgical procedure or major trauma within the past 14 days Autoimmune disease (e.g., Lupus, Multiple Sclerosis) Any medical condition, which in the opinion of the Investigator, renders participation unsuitable Undergone pharmacologic cardioversion or external defibrillation within 24 hours of randomization. Experienced cardiac arrest more than 36 hours after presentation to site or within 24 hours of randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Borow, MD
Organizational Affiliation
Mesoblast, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mercy Gilbert Medical Center / Catholic Health Care West
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California - San Diego (UCSD)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The Care Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
University of Maryland Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Michigan Cardiovascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
University at Buffalo - Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State University - Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
The Stern Cardiovascular Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Austin Heart P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Wisconsin School of Medicine
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada

12. IPD Sharing Statement

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Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)

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