Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00877903 |
|
Recruitment Status :
Completed
First Posted : April 8, 2009
Last Update Posted : January 13, 2022
|
Sponsor:
Mesoblast, Inc.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myocardial Infarction | Drug: Prochymal® Drug: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 220 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 30, 2009 |
| Actual Primary Completion Date : | May 18, 2011 |
| Actual Study Completion Date : | March 14, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Attack
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
Drug: Prochymal®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
Other Name: Remestemcel-L |
|
Placebo Comparator: Placebo
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.
|
Drug: Placebo
Intravenous infusion of excipients of Prochymal® |
Primary Outcome Measures :
- Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3 [ Time Frame: Baseline, Month 3 ]
Secondary Outcome Measures :
- 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 ]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 [ 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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877903
Locations
Show 33 study locations
Sponsors and Collaborators
Mesoblast, Inc.
Investigators
| Study Director: | Ken Borow, MD | Mesoblast, Inc. |
| Responsible Party: | Mesoblast, Inc. |
| ClinicalTrials.gov Identifier: | NCT00877903 |
| Other Study ID Numbers: |
403 |
| First Posted: | April 8, 2009 Key Record Dates |
| Last Update Posted: | January 13, 2022 |
| Last Verified: | January 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
|
Acute myocardial infarction AMI Myocardial infarction Heart attack |
Mesenchymal stem cells MSC Adult human stem cells Osiris |
Additional relevant MeSH terms:
|
Remestemcel-l Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Anti-Inflammatory Agents Antiviral Agents Anti-Infective Agents |