Acute Myocardial InfarctionAcute MINCT01974128
Study to Assess the Safety and Cardiovascular Effects of Autologous Adipose-Derived Stromal Cells Implantation In Patients During the Acute Recovery Phase of ST-Elevation Myocardial Infarction
A study testing ASC isolation and implantation in people with Acute Myocardial Infarction, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- ASC isolation and implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between Age 18 and 80 years.
- Defined acute myocardial infarction <8 days from screening
- Left ventricular ejection fraction at screening of ≤ 50%, with 2 or more contiguous areas of severe wall motion abnormality on resting echocardiography.
- Patients must have a minimum myocardial wall thickness of 5mm
- Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing.
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Who cannot join
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- NYHA CHF Class 4
- Severe valvular or other non-ischemic myocardial disease.
- Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum.
- Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient's infectious status
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- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Systolic blood pressure (supine) ≤90 mmHg;
- Resting heart rate > 100 bpm;
- Active clinical infection within one week of enrollment.
- Cerebrovascular accident within 6 months prior to study entry
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Unwilling and/or not able to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Autologous Adipose-Derived Stromal Cells Implantation by a Catheter Delivery System and/or Intravenously In Patients During the Acute Recovery Phase of ST-Elevation Myocardial Infarction
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
Read the detailed description
The primary objectives of this study are to evaluate in patients recovering from acute myocardial infarction (< 8 days after the index infarction) both the safety profile of intramyocardial ASCs and the preliminary efficacy of ASCs therapy.
This will be an open-label, non-randomized patient sponsored multi-center study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy.
- Conditions
- Acute Myocardial Infarction
- Being tested
- ASC isolation and implantation
- Keywords
- MI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC isolation and implantationProcedure or surgery
This trial will study ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Improvement
Autologous ASCs therapy will be considered effective for post-myocardial infarction patients if there is an improvement in:
- Absolute LVEF
- Changes in LVEF from baseline to 6 months
- MI size
- Regional wall thickness and thickening in all segments
- LV-end systolic volume (LV-ESV)
- LV-end diastolic volume (LV-EDV)
- Change in perfusion defect after revascularization to six months as measured by:
- Echocardiography
- Scintigraphy
Measured: 6 months
Secondary outcomes (1)
Primary Safety Objective
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
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 posted1 Nov 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974128
- Sponsor's protocol ID
- ADI-ME-AMI-001
- Acronym
- Acute MI
- Status last verified
- Mar 2017
- First submitted
- 28 Oct 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Autologous Adipose-Derived Stromal Cells Implantation by a Catheter Delivery System and/or Intravenously In Patients During the Acute Recovery Phase of ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01974128
- Acronym / sponsor ID
- Acute MI / ADI-ME-AMI-001
- Conditions
- Acute Myocardial Infarction
- Keywords
- MI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 1 Nov 2013 (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 intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?
Detailed description
The primary objectives of this study are to evaluate in patients recovering from acute myocardial infarction (< 8 days after the index infarction) both the safety profile of intramyocardial ASCs and the preliminary efficacy of ASCs therapy.
This will be an open-label, non-randomized patient sponsored multi-center study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and Females between Age 18 and 80 years.
- Defined acute myocardial infarction <8 days from screening
- Left ventricular ejection fraction at screening of ≤ 50%, with 2 or more contiguous areas of severe wall motion abnormality on resting echocardiography.
- Patients must have a minimum myocardial wall thickness of 5mm
- Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing.
Key exclusion criteria (15 listed)
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- NYHA CHF Class 4
- Severe valvular or other non-ischemic myocardial disease.
- Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum.
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 |
|---|---|---|
| ASC isolation and implantationThis trial will study ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy | Procedure or surgery | – |
Primary outcome
Cardiac Improvement
Time frame: 6 months
Autologous ASCs therapy will be considered effective for post-myocardial infarction patients if there is an improvement in: * Absolute LVEF * Changes in LVEF from baseline to 6 months * MI size * Regional wall thickness and thickening in all segments * LV-end systolic volume (LV-ESV) * LV-end diastolic volume (LV-EDV) * Change in perfusion defect after revascularization to six months as measured by: * Echocardiography * Scintigraphy
1 secondary outcome
Primary Safety Objective
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASC isolation and implantation in people with Acute Myocardial Infarction, run by Ageless Regenerative Institute at 1 site 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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 21 Jul 2017. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cardiac Improvement (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 21 Jul 2017.