Myocardial InfarctionPhase 2NCT00877903
Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
A Phase 2 study testing Prochymal® in people with Myocardial Infarction, run by Mesoblast, Inc. at 33 sites in 2 countries.
Trial summary
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Prochymal®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 30 Mar 2009to 14 Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States32 sites
Austin Heart P.A.
Austin, Texas, 78756
University of Maryland Hospital
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
University at Buffalo - Buffalo General Hospital
Buffalo, New York, 14203
Fletcher Allen Health Care
Burlington, Vermont, 05401
Rush University Medical Center
Chicago, Illinois, 60612
The Lindner Research Center
Cincinnati, Ohio, 45219
The Ohio State University Medical Center
Columbus, Ohio, 43210
The Stern Cardiovascular Center
Germantown, Tennessee, 38138
Mercy Gilbert Medical Center / Catholic Health Care West
Gilbert, Arizona, 85297
Penn State University - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas Health Science Center
Houston, Texas, 77030
The Care Group
Indianapolis, Indiana, 46290
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Wisconsin School of Medicine
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University
Portland, Oregon, 97239
William Beaumont Hospital
Royal Oak, Michigan, 48073
UC Davis Medical Center
Sacramento, California, 95817
Michigan Cardiovascular Institute
Saginaw, Michigan, 48601
University of California - San Diego (UCSD)
San Diego, California, 92103
Baystate Medical Center
Springfield, Massachusetts, 01199
Stony Brook University Medical Center
Stony Brook, New York, 11794
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66604
University of Arizona
Tucson, Arizona, 85724
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Prochymal®, Placebo
- Keywords
- Acute myocardial infarction, AMI, Myocardial infarction, Heart attack, Mesenchymal stem cells, MSC, Adult human stem cells, Osiris
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prochymal®Drug
Also called Remestemcel-L
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
PlaceboDrug
Intravenous infusion of excipients of Prochymal®
| Study group | Role | What they receive |
|---|---|---|
| Prochymal® | Experimental | 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. Receives: Drug: Prochymal® |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
Measured: Baseline, Month 3
Secondary outcomes (11)
Left Ventricular End Systolic Volume
Measured: 6 months
Infarct Size
Measured: 3 and 6 months
Left Ventricular Ejection Fraction
Measured: 3 and 6 months
Left Ventricular End Diastolic Volume
Measured: 3 and 6 months
Number of Participants with Ventricular Arrhythmias
Measured: 3 and 6 months
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.
Measured: 6, 12, and 24 months
New York Heart Association (NYHA) Congestive Heart Failure Classification Status
Measured: 6, 12, 24, and 60 months
Maximal Symptom-limited Exercise Test (Treadmill)
Measured: 6 and 12 months
Number of Participants with Major Adverse Cardiac Events (MACE)
Measured: 6, 12, 24, and 60 months
Overall Survival
Measured: 60 months
Number of Participants with Adverse Events
Measured: 3,6,12,24,60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study start30 Mar 2009
- Primary completion18 May 2011
- Study completion14 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Borow, MD, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877903
- Sponsor's protocol ID
- 403
- Status last verified
- Nov 2025
- First submitted
- 7 Apr 2009
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00877903
- Acronym / sponsor ID
- 403
- Conditions
- Myocardial Infarction
- Keywords
- Acute myocardial infarction, AMI, Myocardial infarction, Heart attack, Mesenchymal stem cells, MSC, Adult human stem cells, Osiris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2009 (actual)
- Primary completion
- 18 May 2011 (actual)
- Study completion
- 14 Mar 2016 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prochymal® | Experimental | Drug: Prochymal®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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prochymal®Also: Remestemcel-LIntravenous infusion of ex vivo cultured adult human mesenchymal stem cells | Drug | Prochymal® |
| PlaceboIntravenous infusion of excipients of Prochymal® | Drug | Placebo |
Primary outcome
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
Time frame: Baseline, Month 3
11 secondary outcomes
Left Ventricular End Systolic Volume
Time frame: 6 months
Infarct Size
Time frame: 3 and 6 months
Left Ventricular Ejection Fraction
Time frame: 3 and 6 months
Left Ventricular End Diastolic Volume
Time frame: 3 and 6 months
Number of Participants with Ventricular Arrhythmias
Time frame: 3 and 6 months
Duke Activity Status Index (DASI) Assessment
Time frame: 6, 12, and 24 months
New York Heart Association (NYHA) Congestive Heart Failure Classification Status
Time frame: 6, 12, 24, and 60 months
Maximal Symptom-limited Exercise Test (Treadmill)
Time frame: 6 and 12 months
Number of Participants with Major Adverse Cardiac Events (MACE)
Time frame: 6, 12, 24, and 60 months
Overall Survival
Time frame: 60 months
Number of Participants with Adverse Events
Time frame: 3,6,12,24,60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Borow, MD study director
Mesoblast, Inc.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prochymal® in people with Myocardial Infarction, run by Mesoblast, Inc. at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3 (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.