Myocardial InfarctionPhase 1NCT00114452
Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction
A Phase 1 study testing Provacel in people with Myocardial Infarction, run by Mesoblast, Inc. at 15 sites in United States.
Trial 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). 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?
- Provacel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 15 sitesUnited States
- Study dates
- 22 Mar 2005to 24 Apr 2008
- Phase
- Phase 1
- 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
- First heart attack within 1 to 10 days
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Austin Heart Institute
Austin, Texas, 78756
Johns Hopkins University
Baltimore, Maryland, 21205
Rush University Medical Center
Chicago, Illinois, 60612
Texas Medical School
Houston, Texas, 77030
The Care Group
Indianapolis, Indiana, 46260
Jewish Hospital
Louisville, Kentucky, 40202
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Columbia Presbyterian Hospital
New York, New York, 10032
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Arizona Heart Institute
Phoenix, Arizona, 85006
University of Rochester - Strong Memorial
Rochester, New York, 14642
University of California - San Diego; Thornton
San Diego, California, 92103-8411
Washington Adventist
Takoma Park, Maryland, 20912
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Provacel, Placebo
- Keywords
- Acute Myocardial Infarction, Heart Attack, Cardiovascular Disease, Stem cells, Congestive Heart Failure, Heart Attack Repair
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProvacelBiological
ex vivo cultured adult mesenchymal stem cells
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Provacel: Cohort 1 | Active comparator | ex vivo cultured adult mesenchymal stem cells Receives: Biological: Provacel |
| Provacel: Cohort 2 | Active comparator | ex vivo cultured adult mesenchymal stem cells Receives: Biological: Provacel |
| Provacel: Cohort 3 | Active comparator | ex vivo cultured adult mesenchymal stem cells Receives: Biological: Provacel |
| Provacel: Cohort 4 | Active comparator | ex vivo cultured adult mesenchymal stem cells Receives: Biological: Provacel |
| Placebo | Placebo comparator | ex vivo cultured adult mesenchymal stem cells Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2005 (estimated)
- Study start22 Mar 2005
- Primary completion4 Oct 2006
- Study completion24 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT00114452
- Sponsor's protocol ID
- 401-402
- Status last verified
- Mar 2020
- First submitted
- 14 Jun 2005
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 12480809Pittenger 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.
PubMed 15242981Shake 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.
PubMed 12078791Hare 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.
PubMed 19958962
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00114452
- Acronym / sponsor ID
- 401-402
- Conditions
- Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Heart Attack, Cardiovascular Disease, Stem cells, Congestive Heart Failure, Heart Attack Repair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2005 (actual)
- Primary completion
- 4 Oct 2006 (actual)
- Study completion
- 24 Apr 2008 (actual)
- First posted
- 15 Jun 2005 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Provacel: Cohort 1 | Active comparator | Biological: Provacelex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 2 | Active comparator | Biological: Provacelex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 3 | Active comparator | Biological: Provacelex vivo cultured adult mesenchymal stem cells |
| Provacel: Cohort 4 | Active comparator | Biological: Provacelex vivo cultured adult mesenchymal stem cells |
| Placebo | Placebo comparator | Biological: Placeboex vivo cultured adult mesenchymal stem cells |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female between 21 and 85 years old
- First heart attack within 1 to 10 days
Key exclusion criteria (12 listed)
- Positive for HIV 1 and 2
- Previous heart attack
- Pacemaker or other device
- Pregnant or breastfeeding
- Allergic to cow or pig derived products
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 |
|---|---|---|
| Provacelex vivo cultured adult mesenchymal stem cells | Biological | Provacel: Cohort 1, Provacel: Cohort 2, Provacel: Cohort 3, Provacel: Cohort 4 |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
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.
Time frame: 6 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 10 Mar 2020.
- Background: PubMed 12480809Orlic 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.
- Background: PubMed 15242981Pittenger 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.
- Background: PubMed 12078791Shake 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.
- Derived from this study: PubMed 19958962Hare 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.
- Click here for more information about heart diseaseLink provided by the sponsor.
- Click here for more information about this study and adult mesenchymal stem cells.Link provided by the sponsor.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Provacel in people with Myocardial Infarction, run by Mesoblast, Inc. at 15 sites in United States.
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 2 inclusion and 12 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114452, which also lists 4 linked publications.
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 10 Mar 2020.