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Non-Ischemic Congestive Heart FailureNCT01502501

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

A study testing Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs) in people with Non-Ischemic Congestive Heart Failure, run by Ageless Regenerative Institute at 1 site in Mexico.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-Ischemic Congestive Heart Failure
What is being tested?
Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)
How many people
0 participants
Where
1 siteMexico
Study dates
May 2011to Jun 2015
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

  • Willing and able to sign informed consent
  • Age >18 years and < 80 years
  • NYHA Class II-IV
  • Congestive Heart Failure without an acute coronary syndrome during the prior 6 months
  • 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+)
  • Up to date on all age and gender appropriate cancer screening per American Cancer Society

Who cannot join

  • Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular disease, arthritis or other musculoskeletal disorders
  • Inability to complete a 6-minute walk test for any reason
  • Need for intravenous CHF medications, chronic continuous oxygen therapy or oral steroids,
  • Coronary Artery Bypass Surgery (CABG) surgery within 60 days prior to screening
  • Planned revascularization within 4 months following enrollment
  • Aortic aneurysm or dilatation (>3.8 cm by echocardiography or other imaging modality)
Show all 18Show fewer
  • Peripheral vascular disease at or below the distal aorta that may interfere with catheter use
  • Hemodynamically significant pericardial disease
  • Prior aortic or mitral valve replacement
  • Biventricular pacing device implant within the last 3 months OR whose device is scheduled to be revised following enrollment in this trial
  • Scheduled to receive or history of cardiac transplant, surgical remodeling procedure, left ventricular assist device
  • Stroke within 180 days of screening
  • Positive pregnancy test in women of child bearing potential or who are unwilling to use an acceptable method of contraception.
  • Drug or alcohol dependence
  • Life expectancy of less than 1 year
  • History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in the last five years
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto de Medicina Regenerativa

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

About this study

Official title: 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?
Read the 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.

Being tested
Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)
Keywords
CHF, Heart Failure, Non-Ischemic, nonischemic, nonischemia
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)Procedure or surgery

    Also called Lipo, Liposuction, Catheter, IV

    Local liposuction procedure to harvest the fat tissue. Adipose Derived Stem Cells are then implanted via intramyocardial and intravenous injection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in 6 minute walk test

    compared to baseline

    Measured: 3 months

  2. Minnesota Living with Heart Failure Quality of Life Questionnaire

    Measured: 3 months

  3. Improvement in 6 minute walk test

    Measured: 6 months

  4. Minnesota Living with Heart Failure Quality of Life Questionnaire

    Measured: 6 months

  5. Number of Adverse Events

    Measured: 6 months

Secondary outcomes (6)

  1. Improvement in New York Heart Association (NYHA) classification

    Measured: 3 months

  2. Improvement in the Left Ventricular Ejection Fraction (LVEF)

    Determined by and echo

    Measured: 3 months

  3. Improvement in the Left Ventricular (LV) Volume

    Determined by an echo

    Measured: 3 months

  4. Improvement in New York Heart Association (NYHA) classification

    Measured: 6 months

  5. Improvement in the Left Ventricular Ejection Fraction (LVEF)

    Measured: 6 months

  6. Improvement in the Left Ventricular (LV) Volume

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2014 (estimated)
  4. Study completionJun 2015 (estimated)

Why it stopped: no participants enrolled

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01502501
Sponsor's protocol ID
ADI-ME-CHF-001
Status last verified
Jul 2017
First submitted
27 Dec 2011
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs) in people with Non-Ischemic Congestive Heart Failure, run by Ageless Regenerative Institute at 1 site in Mexico.

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 8 inclusion and 18 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 Mexico. 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?

Improvement in 6 minute walk test (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502501.

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.

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