Myocardial InfarctionPhase 3NCT02672267
A Study of Allogeneic Low Oxygen Mesenchymal Bone Marrow Cells in Subjects With Myocardial Infarction
A Phase 3 study testing Stem cells in people with Myocardial Infarction, run by Altaco XXI, LLP at 1 site in Kazakhstan.
Trial summary
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jul 2014to Apr 2016
- Phase
- Phase 3
- 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
- Males and females 18-85 years of age.
- First Acute Myocardial Infarction (STEMI, non STEMI) within 7 days of study enrollment. Myocardial infarction is defined as ECG, Lab and CMR evidences.
- Subject had successful revascularization within 12 hours of symptoms as evidenced by residual stenosis < 30% and TIMI antegrade flow II or III in the culprit vessel. Revascularization may include one of the following:
- PCI angioplasty/stenting placement
- Thrombolytic therapy
- Life expectancy greater than 12 months.
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- Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.
- Reasonable expectation that subject will receive standard post myocardial infarction care, unless contraindicated, including medications: • Anticoagulation (e.g. aspirin, clopidogrel, ticlopidine, prasugrel, etc.), beta-blockers, ace inhibitors, and statin agents, as tolerated.
- Attend all scheduled safety follow-up visits.
Who cannot join
- Hemodynamic instability as demonstrated by any of the following:
- Requirement of intra-aortic balloon pump of left ventricular assist device.
- Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥60 mmHg.
- History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
- Clinically-significant hematologic, hepatic, or renal impairment within 24 hours of study procedure as determined by screening clinical laboratory tests. Severe chronic anemia or hematocrit ≤24%. Liver function tests (total bilirubin at 3 times upper limit of normal, or creatinine level ≥3mg/dL).
- Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject.
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- Participation in another study with an investigational drug or device within 3 months prior to stem cell administration.
- History within the past year of drug or alcohol abuse.
- Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study.
- Inability to comply with the conditions of the protocol.
- Presence of a transplanted tissue or organ or left ventricular assist device (LVAD) (or the expectation of the same within the next 12 months).
- Planned Automatic Implantable Cardiac Defibrillator (AICD) or CRT within the next 12 months.
- Need for chronic intermittent inotropic therapy.
- Active myocarditis or early postpartum cardiomyopathy (within the first twelve months of delivery).
- Porphyria.
- Allergy to sodium citrate or any "caine" type of local anesthetic.
- Subject scheduled for hospice care.
- Clinically relevant abnormal findings in the clinical history, physical examination, ECG (e.g. life threatening arrhythmias, including QTc interval of ≥550 ms) or laboratory tests at the screening assessment that would interfere with the objectives of the study or that would, in the Investigator's opinion, preclude safe completion of the study.
- Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as subjects undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.
- Any other medical, social, or geographical factor that would make it unlikely that the subject could comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of noncompliance).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Double-blinded, Single Center, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Single Intravenous Dose of Allogeneic Ischemia Tolerant Human Mesenchymal Bone Marrow Cells to Subjects With Acute Myocardial Infarction
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).
Read the detailed description
Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality despite continuing advances in various treatment options. In developed countries, ischemic heart disease causes more than 50% of all cardiovascular deaths.
Stem cell transplantation has the potential to repair and improve cardiac function, thus helping to significantly decrease morbidity and mortality rates. Preclinical data from a variety of animal studies demonstrated the capacity for skeletal myoblasts to engraft, form myotubules, and enhance cardiac function after transplantation into infarcted myocardium. The underlying sequela of the post infarcted left ventricle often includes massive damage to the cardiomyocyte. The left ventricle remodeling (dilation) and dysfunction is thought to be irreversible. The development of treatments that will regenerate its musculature and vascular components is now considered a main therapeutic challenge. Preliminary human studies focusing on subjects with ischemic heart disease have demonstrated successful myoblast transplantation into the post infarction scar. Another study demonstrated the benefits of stem cell therapy on ventricular function and profusion.
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications. These clinical trials showed excellent safety, reduction in arrhythmias, improvement in functional status and increased ejection fraction.
The hMSCs are able to:
- Prevent reperfusion injury;
- Prevent excessive fibrosis;
- Reestablish function of hibernating cardiomyocytes in peripheral zone area.
- Reestablish angiogenesis/vasculogenesis;
- Preserve wall motion (prevent arrhythmia and functional contractile deterioration);
- Prevent post infarct ventricular remodeling and left ventricular dilation. It is well accepted that dilated cardiomyopathy mortality rates are 50% within 5 years of diagnosis;
- Limit infarct size. If we can preserve and restore cardiac function as measured by ejection fraction and LVESV preserving left ventricular integrity would increase subject quality of life as well as longevity.
- Conditions
- Myocardial Infarction
- Being tested
- Stem cells, Placebo
- Keywords
- AMI, hBMMSCs, stem cells,
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cellsBiological
Also called Allogeneic Low Oxygen mesenchymal stem cells
human Allogeneic Low Oxygen mesenchymal stem cells; Ischemia tolerant
PlaceboOther
Lactated Ringer's Solution
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells | Experimental | Experimental: Stem Cells ALLOGENEIC LOW OXYGEN MESENCHYMAL BONE MARROW CELLS Intervention: Biological: Stem cells Receives: Biological: Stem cells |
| Placebo | Placebo comparator | Lactated Ringer's Solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of aMBMC intravenous administration during the six month study period as determined by major adverse events MACE endpoint
Measured: 6 months
Secondary outcomes (5)
The change from baseline on physical exam conducted at 1, 3 and 6 months post-administration
Measured: 6 months
LV end diastolic volume
measured by MRI
Measured: 3 months
LV end systolic volume
measured by MRI
Measured: 3 months
Infarct size measured by MRI, with contrast
measured by MRI
Measured: 3 months
Global Left Ventricular Ejection Fraction
measured by MRI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionApr 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altaco XXI, LLP
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Saule Abseitova, MD, Prof., Principal investigator, National Research Medical CenterDaniyar Jumaniyazov, MD, PhD, Study director, Altaco XXI, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672267
- Sponsor's protocol ID
- CARDIO 1/2
- Status last verified
- Apr 2016
- First submitted
- 1 Feb 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blinded, Single Center, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Single Intravenous Dose of Allogeneic Ischemia Tolerant Human Mesenchymal Bone Marrow Cells to Subjects With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02672267
- Acronym / sponsor ID
- CARDIO 1/2
- Conditions
- Myocardial Infarction
- Keywords
- AMI, hBMMSCs, stem cells,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Altaco XXI, LLPUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Feb 2016 (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 this study is to assess the safety, tolerability and preliminary efficacy of human allogeneic ischemia tolerant mesenchymal bone marrow cells (aLoOxMBMC) administered intravenously to subjects with Acute Myocardial Infarction (STEMI, non STEMI).
Detailed description
Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality despite continuing advances in various treatment options. In developed countries, ischemic heart disease causes more than 50% of all cardiovascular deaths.
Stem cell transplantation has the potential to repair and improve cardiac function, thus helping to significantly decrease morbidity and mortality rates. Preclinical data from a variety of animal studies demonstrated the capacity for skeletal myoblasts to engraft, form myotubules, and enhance cardiac function after transplantation into infarcted myocardium. The underlying sequela of the post infarcted left ventricle often includes massive damage to the cardiomyocyte. The left ventricle remodeling (dilation) and dysfunction is thought to be irreversible. The development of treatments that will regenerate its musculature and vascular components is now considered a main therapeutic challenge. Preliminary human studies focusing on subjects with ischemic heart disease have demonstrated successful myoblast transplantation into the post infarction scar. Another study demonstrated the benefits of stem cell therapy on ventricular function and profusion.
Allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications. These clinical trials showed excellent safety, reduction in arrhythmias, improvement in functional status and increased ejection fraction.
The hMSCs are able to:
- Prevent reperfusion injury;
- Prevent excessive fibrosis;
- Reestablish function of hibernating cardiomyocytes in peripheral zone area.
- Reestablish angiogenesis/vasculogenesis;
- Preserve wall motion (prevent arrhythmia and functional contractile deterioration);
- Prevent post infarct ventricular remodeling and left ventricular dilation. It is well accepted that dilated cardiomyopathy mortality rates are 50% within 5 years of diagnosis;
- Limit infarct size. If we can preserve and restore cardiac function as measured by ejection fraction and LVESV preserving left ventricular integrity would increase subject quality of life as well as longevity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem Cells | Experimental | Biological: Stem cellsExperimental: Stem Cells ALLOGENEIC LOW OXYGEN MESENCHYMAL BONE MARROW CELLS Intervention: Biological: Stem cells |
| Placebo | Placebo comparator | Other: PlaceboLactated Ringer's Solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females 18-85 years of age.
- First Acute Myocardial Infarction (STEMI, non STEMI) within 7 days of study enrollment. Myocardial infarction is defined as ECG, Lab and CMR evidences.
- Subject had successful revascularization within 12 hours of symptoms as evidenced by residual stenosis < 30% and TIMI antegrade flow II or III in the culprit vessel. Revascularization may include one of the following:
- Life expectancy greater than 12 months.
- Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.
Key exclusion criteria (20 listed)
- Hemodynamic instability as demonstrated by any of the following:
- History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
- Clinically-significant hematologic, hepatic, or renal impairment within 24 hours of study procedure as determined by screening clinical laboratory tests. Severe chronic anemia or hematocrit ≤24%. Liver function tests (total bilirubin at 3 times upper limit of normal, or creatinine level ≥3mg/dL).
- Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject.
- Participation in another study with an investigational drug or device within 3 months prior to stem cell administration.
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 |
|---|---|---|
| Stem cellsAlso: Allogeneic Low Oxygen mesenchymal stem cellshuman Allogeneic Low Oxygen mesenchymal stem cells; Ischemia tolerant | Biological | Stem Cells |
| PlaceboLactated Ringer's Solution | Other | Placebo |
Primary outcome
The safety and tolerability of aMBMC intravenous administration during the six month study period as determined by major adverse events MACE endpoint
Time frame: 6 months
5 secondary outcomes
The change from baseline on physical exam conducted at 1, 3 and 6 months post-administration
Time frame: 6 months
LV end diastolic volume
Time frame: 3 months
LV end systolic volume
Time frame: 3 months
Infarct size measured by MRI, with contrast
Time frame: 3 months
Global Left Ventricular Ejection Fraction
Time frame: 3 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 6 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Saule Abseitova, MD, Prof. principal investigator
National Research Medical Center
Daniyar Jumaniyazov, MD, PhD study director
Altaco XXI, LLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stem cells in people with Myocardial Infarction, run by Altaco XXI, LLP at 1 site in Kazakhstan.
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 9 inclusion and 20 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 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The safety and tolerability of aMBMC intravenous administration during the six month study period as determined by major adverse events MACE endpoint (time frame: 6 months). 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 6 Oct 2016.