Heart AttackPhase 2MI-NSTEMINCT02277613
A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
A Phase 2 study testing AMI MultiStem cells in people with Heart Attack and NSTEMI, run by Healios K.K. at 11 sites in United States.
Trial summary
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Attack, NSTEMI
- What is being tested?
- AMI MultiStem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2015to Jan 2020
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of either gender, 18-85 years of age, inclusive
- Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
- Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%
Who cannot join
- Previous Coronary Artery Bypass Graft (CABG)
- Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
- Previous solid organ transplant
- Anticipated need for additional planned coronary revascularization procedure(s)
- Hemodynamic instability
- Mechanical complications of the index acute myocardial infarction
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Akron, Ohio
Study site
Birmingham, Alabama
Study site
Clearwater, Florida
Study site
Detroit, Michigan
Study site
Gainesville, Florida
Study site
Huntsville, Alabama
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
Tampa, Florida, 33614
About this study
Official title: A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
- Conditions
- Heart Attack, NSTEMI
- Being tested
- AMI MultiStem cells, Sham
- Keywords
- stem cells
- Medical subject headings
- Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMI MultiStem cellsBiological
AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
ShamOther
Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
| Study group | Role | What they receive |
|---|---|---|
| AMI MultiStem cells | Experimental | AMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo. Receives: Biological: AMI MultiStem cells |
| Sham | Sham comparator | Sham procedure using Micro-Infusion Catheter in coronary artery without injection. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Measured: 30 days
To assess the effects of AMI MultiStem therapy on cardiac function
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
Measured: Day 120
Secondary outcomes (3)
To assess the effects of AMI MultiStem therapy on cardiac function
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
Measured: Day 365
To assess the incidence of Major Adverse Cardiovascular Events (MACE)
To compare the incidence of MACE between AMI MultiStem therapy treated subjects and Sham treated subjects
Measured: Day 365
Incidence and severity of adverse events
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startDec 2015
- Primary completionJun 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart AttackStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healios K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marc Penn, MD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277613
- Sponsor's protocol ID
- B02-02
- Other IDs
- 1R44HL117572-01A1
- Acronym
- MI-NSTEMI
- Status last verified
- Jul 2021
- First submitted
- 24 Oct 2014
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Prospective, Randomized, Double-blind, Sham-controlled, Parallel-group, Multi-center Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02277613
- Acronym / sponsor ID
- MI-NSTEMI / B02-02
- Conditions
- Heart Attack, NSTEMI
- Keywords
- stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Healios K.K.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 29 Oct 2014 (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.
This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMI MultiStem cells | Experimental | Biological: AMI MultiStem cellsAMI MultiStem cells is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo. |
| Sham | Sham comparator | Other: ShamSham procedure using Micro-Infusion Catheter in coronary artery without injection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of either gender, 18-85 years of age, inclusive
- Diagnosis of non-ST elevation myocardial infarction (NSTEMI)
- Left Ventricular Ejection Fraction (LVEF) between ≥ 25 and ≤ 45%
Key exclusion criteria (6 listed)
- Previous Coronary Artery Bypass Graft (CABG)
- Previous autologous, allogeneic bone marrow or peripheral stem cell transplant
- Previous solid organ transplant
- Anticipated need for additional planned coronary revascularization procedure(s)
- Hemodynamic instability
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 |
|---|---|---|
| AMI MultiStem cellsAMI MultiStem cells administration in coronary artery with a micro-infusion catheter. | Biological | AMI MultiStem cells |
| ShamSham procedure using Micro-Infusion Catheter in coronary artery without injection. | Other | Sham |
Primary outcome
Incidence and severity of adverse events
Time frame: 30 days
To compare the difference in the incidence and severity of adverse events between AMI MultiStem therapy treated subjects and Sham treated subjects
To assess the effects of AMI MultiStem therapy on cardiac function
Time frame: Day 120
To compare the changes in cardiac function assessed by cardiac MRI between AMI MultiStem therapy treated subjects and Sham treated subjects
3 secondary outcomes
To assess the effects of AMI MultiStem therapy on cardiac function
Time frame: Day 365
To assess the incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Day 365
Incidence and severity of adverse events
Time frame: Day 365
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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.
Marc Penn, MD principal investigator
Summa Health System
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMI MultiStem cells in people with Heart Attack and NSTEMI, run by Healios K.K. at 11 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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 was stopped early. Results are not available in the source record.
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?
Incidence and severity of adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. 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 22 Jul 2021.