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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 (Acute MI)

Primary Purpose

Acute Myocardial Infarction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASC isolation and implantation
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring MI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Ageless Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2013
Last Updated
July 19, 2017
Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
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1. Study Identification

Unique Protocol Identification Number
NCT01974128
Brief Title
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
Acronym
Acute MI
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
MI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ASC isolation and implantation
Intervention Description
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
Primary Outcome Measure Information:
Title
Cardiac Improvement
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Primary Safety Objective
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Facility Information:
Facility Name
Ageless Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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