Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium

April 27, 2011 updated by: TCA Cellular Therapy

Phase I Study to Determine the Safety and Feasibility of the Use of a Combination Stem Cell Therapy in Patients With Acute Myocardial Infarction

The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. End points will be the assessment of development of mature and stable new blood vessels as well as improvement in cardiac function.

This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the safety and feasibility of use of the proposed combination of autologous stem cells. Potential subjects who fulfill clinical and laboratory entry criteria at screening will undergo a process of bone marrow aspiration for preparation of the two types of bone marrow-derived stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant, patients will be have a 3 month follow-up to evaluate safety as well as functional heart improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.

Study population will include adult male and female subjects, ages 18-70, presenting with acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial infarction and will undergo coronary artery bypass grafting.

Patients will be divided in two groups:

  • the first group will enroll patients with acute myocardial infarction whom percutaneous coronary intervention restored myocardial flow after 4 hours or greater of the initiation of symptoms,
  • the second group will enroll patients who are candidates for coronary artery bypass surgery and had a myocardial infarction in the past 12 months.

Patients will receive the cell mixture by intracoronary or intramyocardial infusion, respectively.

The rationale of this clinical study is based on the observation that most attempts using adult stem cells for myocardial regeneration have utilized a source of bone marrow derived progenitor cells with the potential to generate new blood vessel and thus contribute to the revascularization of the ischemic tissue. This therapy seems to be adequate but not sufficient, since it lacks a source of stem cells capable of differentiating and maturing into cardiac muscle cells, thus contributing to the recovery of local contractility. The proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at contributing cell types capable of regenerating both blood vessels and muscle tissues damaged after MI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • TCA Cellular Therapy, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ARM: A -

  • Patients with acute myocardial infarction with ST elevation who underwent percutaneous revascularization between 4 and 24 hours after the initiation of symptoms.

    1. Able to give written informed consent
    2. Age: 18 to 70 years
    3. Gender: Male and Female

    4. Acute myocardial infarction occurring within 4-24 hours after onset of symptoms documented by at least one of the following:

      1. ST Segment elevation greater than 2mm in two or more consecutive leads
      2. New Bundle Branch Block with symptoms consistent of MI
      3. Troponin I greater than 2.0 ng/ml (Normal Range 0 - 1.5 ng/ml)
      4. Totally occluded artery as visualized by angiography

ARM - B

Patients who are candidates for coronary artery bypass grafting surgery according to ACC/AHA guidelines and have had a myocardial infarction in the past 12 months.

  1. Able to give written informed consent
  2. Patients with coronary artery disease who need coronary artery bypass surgery according to ACC/AHA guidelines
  3. Patients with Left Ventricular Ejection Fraction £ 40%.
  4. NYHA symptoms Class II (dyspnea with moderate effort)
  5. Defined region of myocardial dysfunction related to previous myocardial infarction (within the past 12 months) involving the anterior, lateral, posterior or inferior walls by either of the followings: echocardiography, ventriculography, MRI, or SPECT.
  6. Age: 18 to 70 years
  7. Gender: Male and Female

Exclusion Criteria:

ARM - A

  1. Pregnancy
  2. Previous angiogenic therapy or myocardial laser therapy
  3. History of cancer within 5 years
  4. Known sensitivity to gentamycin and/or amphotericin B
  5. Use or expected use of antineoplastic drugs
  6. No informed consent or unable to provide informed consent.
  7. Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient's safety, or interfere with the interpretation of the study results.
  8. Any illness which might affect patient's survival over the study follow-up period
  9. History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.
  10. Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis
  11. Cardiogenic shock or severe compromise in left ventricular systolic function defined as ejection fraction lower than 20 %.
  12. History of intolerance to amiodarone.
  13. End stage renal disease
  14. Contraindication for MRI
  15. Any significant laboratory abnormality which will in the investigator's opinion interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study result.
  16. Inability to identify the infarct area intra operatively

ARM - B

  1. Previous angiogenic therapy or myocardial laser therapy
  2. History of cancer within 5 years
  3. Cardiogenic shock or severe compromise in left ventricular systolic function defined as ejection fraction lower than 20 %.
  4. Left Ventricular Ejection Fraction ≥ 40%.
  5. Known sensitivity to gentamycin and/or amphotericin B
  6. Use or expected use of antineoplastic drugs
  7. No informed consent or unable to provide informed consent
  8. 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
  9. Any illness which might affect patient's survival over the study follow-up period
  10. History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e.,ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.
  11. Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis
  12. Poor candidates for coronary artery bypass surgery
  13. Patients who are in need of emergency bypass surgery
  14. History of prior coronary artery bypass surgery
  15. Patients with severe valvular heart disease
  16. History of intolerance to amiodarone
  17. End stage renal disease
  18. Pregnancy
  19. Contraindication for MRI
  20. Any significant laboratory abnormality which will in the investigator's opinion interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study result.
  21. Inability to identify infarct area intra operatively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Patients with documented acute myocardial infarction (heart attack) occurring within 4-24 hours after onset of symptoms
Biological: MESENDO
Intracoronary transplantation of autologous stem cells via balloon catheter
Biological: MESENDO
Intracardiac transplantation of autologous stem cells via direct injection
Experimental: B
Candidates for coronary artery bypass grafting that suffered a myocardial infarction (heart attack) within the past 12 months
Biological: MESENDO
Intracoronary transplantation of autologous stem cells via balloon catheter
Biological: MESENDO
Intracardiac transplantation of autologous stem cells via direct injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TCA Cellular Therapy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabriel P. Lasala, M.D., TCA Cellular Therapy, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-02-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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