Ischemic Congestive Heart FailurePhase 1NCT01502514
Safety and Efficacy of Adipose Derived Stem Cells for Congestive Heart Failure
A Phase 1 study testing Fat Harvesting and Implantation of Adipose Derived Stem Cells in people with Ischemic Congestive Heart Failure, run by Ageless Regenerative Institute at 1 site in Mexico.
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
- Ischemic Congestive Heart Failure
- What is being tested?
- Fat Harvesting and Implantation of Adipose Derived Stem Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to Jun 2015
- Phase
- Phase 1
- 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
- New York Heart Association (NYHA) Class II-IV
- Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months
- Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% measured by echocardiography at both local and investigative sites, AND:
- Well-demarcated region of LV systolic dysfunction.
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- 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 therapyor oral steroids,
- Coronary Artery Bypass Graft (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)
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- 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
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 Ischemic Congestive Heart Failure Patients
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- 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 experienced myocardial infarction. 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.
- Conditions
- Ischemic Congestive Heart Failure
- Being tested
- Fat Harvesting and Implantation of Adipose Derived Stem Cells
- Keywords
- CHF, ischemia, Heart Failure
- Medical subject headings
- Ischemia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat Harvesting and Implantation of Adipose Derived Stem CellsProcedure or surgery
Also called Liposuction, ADSC, ASC, Stem Cell therapy
Local Liposuction will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in 6 Minute Walk Test
Measured: 3 months
Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire
Measured: 3 months
Improvement in 6 Minute Walk Test
Measured: 6 months
Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire
Measured: 6 months
Secondary outcomes (6)
Improvement in New York Heart Association classification
Measured: 3 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Determined by an echo
Measured: 3 months
Improvement inn the Left Ventricular Volume
Measured: 3 months
Improvement in New York Heart Association classification
Measured: 6 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Measured: 6 months
Improvement in the Left Ventricular 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.
- First posted30 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Congestive Heart FailureStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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
- Investigators
- Juan J Parcero, MD, Principal investigator, Instituto de Medicina Regenerativa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502514
- Sponsor's protocol ID
- ADI-ME-CHF-002
- Status last verified
- Jul 2017
- First submitted
- 27 Dec 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Comella K, Parcero J, Bansal H, Perez J, Lopez J, Agrawal A, Ichim T. Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy. J Transl Med. 2016 Jun 2;14(1):158. doi: 10.1186/s12967-016-0918-5.
PubMed 27255774
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 Intramyocardial and Intravenous Implantation of Autologous Adipose-Derived Stem Cells in Ischemic Congestive Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01502514
- Acronym / sponsor ID
- ADI-ME-CHF-002
- Conditions
- Ischemic Congestive Heart Failure
- Keywords
- CHF, ischemia, Heart Failure
- Phase
- Phase 1
- 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
- May 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Dec 2011 (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:
- Is the proposed treatment safe
- 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?
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 experienced myocardial infarction. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (9 listed)
- Willing and able to sign informed consent
- Age >18 years and < 80 years
- New York Heart Association (NYHA) Class II-IV
- Ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months
- Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% measured by echocardiography at both local and investigative sites, AND:
Key exclusion criteria (18 listed)
- 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 therapyor oral steroids,
- Coronary Artery Bypass Graft (CABG) surgery within 60 days prior to screening
- Planned revascularization within 4 months following enrollment
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 |
|---|---|---|
| Fat Harvesting and Implantation of Adipose Derived Stem CellsAlso: Liposuction, ADSC, ASC, Stem Cell therapyLocal Liposuction will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously. | Procedure or surgery | – |
Primary outcome
Improvement in 6 Minute Walk Test
Time frame: 3 months
Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire
Time frame: 3 months
Improvement in 6 Minute Walk Test
Time frame: 6 months
Improvement in the Minnesota Living with Heart Failure Quality of Life Questionnaire
Time frame: 6 months
6 secondary outcomes
Improvement in New York Heart Association classification
Time frame: 3 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Time frame: 3 months
Improvement inn the Left Ventricular Volume
Time frame: 3 months
Improvement in New York Heart Association classification
Time frame: 6 months
Improvement in the Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Improvement in the Left Ventricular Volume
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.
- Derived from this study: PubMed 27255774Comella K, Parcero J, Bansal H, Perez J, Lopez J, Agrawal A, Ichim T. Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy. J Transl Med. 2016 Jun 2;14(1):158. doi: 10.1186/s12967-016-0918-5.
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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.
Juan J Parcero, MD principal investigator
Instituto de Medicina Regenerativa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fat Harvesting and Implantation of Adipose Derived Stem Cells in people with 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 9 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 4 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 NCT01502514, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 8 Nov 2026.