Safety and Efficacy of Adipose Derived Stem Cells for Non-Ischemic Congestive Heart Failure

July 19, 2017 updated by: Ageless Regenerative Institute

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Intramyocardial and Intravenous Implantation of Autologous Adipose-Derived Stem Cells in Non-Ischemic Congestive Heart Failure Patients

The intent of this clinical study is to answer the questions:

  1. Is the proposed treatment safe
  2. Is treatment effective in improving the disease pathology of patients with Heart Disease as assessed by a series of measurements indicating improvement, stability, or degradation of a patient's cardiovascular function and exercise capacity?

Study Overview

Status

Status

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Withdrawn

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.

Detailed Description

This will be an open-label, non-randomized, multi-center patient-sponsored study designed to assess the safety and cardiovascular effects of Adipose-derived Stem Cell (ASC) implantation using a catheter delivery system in patients who have nonischemic congestive heart failure. A percutaneous transluminal endomyocardial injection catheter will be used for delivery of ASCs. The therapy is composed of cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.

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

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.
  • Not Applicable

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

  • Mexico
    • Baja California
      • Tijuana, Baja California, Mexico, 22010
        • Instituto de Medicina Regenerativa

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Willing and able to sign informed consent
  2. Age >18 years and < 80 years
  3. NYHA Class II-IV
  4. Congestive Heart Failure without an acute coronary syndrome during the prior 6 months

  5. LVEF less than or equal to 40% measured by echocardiography at both local and investigative sites, AND

    • Left ventricular wall without mural thrombus and of thickness greater than 0.5 cm
    • No significant valvular disease including: Moderate-to-severe mitral regurgitation (3-4+), aorticstenosis (valve area <1.5 cm2), aortic insufficiency (3-4+)
  6. Up to date on all age and gender appropriate cancer screening per American Cancer Society

Exclusion Criteria:

  1. Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular disease, arthritis or other musculoskeletal disorders
  2. Inability to complete a 6-minute walk test for any reason
  3. Need for intravenous CHF medications, chronic continuous oxygen therapy or oral steroids,
  4. Coronary Artery Bypass Surgery (CABG) surgery within 60 days prior to screening
  5. Planned revascularization within 4 months following enrollment
  6. Aortic aneurysm or dilatation (>3.8 cm by echocardiography or other imaging modality)
  7. Peripheral vascular disease at or below the distal aorta that may interfere with catheter use
  8. Hemodynamically significant pericardial disease
  9. Prior aortic or mitral valve replacement
  10. Biventricular pacing device implant within the last 3 months OR whose device is scheduled to be revised following enrollment in this trial
  11. Scheduled to receive or history of cardiac transplant, surgical remodeling procedure, left ventricular assist device
  12. Stroke within 180 days of screening
  13. Positive pregnancy test in women of child bearing potential or who are unwilling to use an acceptable method of contraception.
  14. Drug or alcohol dependence
  15. Life expectancy of less than 1 year
  16. History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in the last five years
  17. Exposure to angiogenic therapy (including myocardial laser) or another investigational drug within 60 days of screening, or enrollment in any concurrent study that may confound the results of this study
  18. Any factors in the opinion of the Investigator which render the patient unsuitable for participation, that will interfere with conduct of the study or interpretation of the results.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Measure Description
Time Frame
Improvement in 6 minute walk test
Time Frame: 3 months
compared to baseline
3 months
Minnesota Living with Heart Failure Quality of Life Questionnaire
Time Frame: 3 months
3 months
Improvement in 6 minute walk test
Time Frame: 6 months
6 months
Minnesota Living with Heart Failure Quality of Life Questionnaire
Time Frame: 6 months
6 months
Number of Adverse Events
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in New York Heart Association (NYHA) classification
Time Frame: 3 months
3 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Time Frame: 3 months
Determined by and echo
3 months
Improvement in the Left Ventricular (LV) Volume
Time Frame: 3 months
Determined by an echo
3 months
Improvement in New York Heart Association (NYHA) classification
Time Frame: 6 months
6 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Time Frame: 6 months
6 months
Improvement in the Left Ventricular (LV) Volume
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.
Ageless Regenerative Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Medicina Regenerativa

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: Juan J Parcero, MD, Instituto de Medicina Regenerativa

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.
May 1, 2011

Primary Completion (Anticipated)

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, 2014

Study Completion (Anticipated)

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.
June 1, 2015

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).
December 27, 2011

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.
December 29, 2011

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.
December 30, 2011

Study Record Updates

Last Update Posted (Actual)

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.
July 21, 2017

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.
July 19, 2017

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.
July 1, 2017

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.
  • ADI-ME-CHF-001

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings