Heart FailureNCT01576757
Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
An observational study of Heart Failure, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2012
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure undergoing evaluation for medical management at the University of Louisville or Jewish Hospital in Louisville, KY will be considered for participation based on the evaluation of enrollment criteria.
Who may be able to join
- Any heart failure patient scheduled for RHC without contraindication for biopsy.
- Any patient undergoing biopsy for diagnostic purposes may also be included in the study.
Who cannot join
- Severe comorbidities (AST, ALT, serum creatinine > 3 times the upper limit of normal).
- Pregnancy or women of childbearing potential.
- Anticoagulation which cannot be stopped for 5-7 days.
- Hepatitis B, C or HIV.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.
Read the detailed description
Heart failure is a devastating condition affecting nearly 6 million patients in the United States alone. Ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. Stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. Recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. The ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. The results of this study will be important for the design of future clinical trials.
- Conditions
- Heart Failure
- Keywords
- Stem cell therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: There were no funds for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Roberto Bolli, University of Louisville
- Investigators
- Roberto Bolli, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576757
- Sponsor's protocol ID
- UL-11.0146
- Status last verified
- Jul 2018
- First submitted
- 10 Apr 2012
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies
- ClinicalTrials.gov ID
- NCT01576757
- Acronym / sponsor ID
- UL-11.0146
- Conditions
- Heart Failure
- Keywords
- Stem cell therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: There were no funds for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Feb 2011 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Apr 2012 (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 purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.
Detailed description
Heart failure is a devastating condition affecting nearly 6 million patients in the United States alone. Ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. Stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. Recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. The ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. The results of this study will be important for the design of future clinical trials.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | –Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure undergoing evaluation for medical management at the University of Louisville or Jewish Hospital in Louisville, KY will be considered for participation based on the evaluation of enrollment criteria.
Key inclusion criteria (2 listed)
- Any heart failure patient scheduled for RHC without contraindication for biopsy.
- Any patient undergoing biopsy for diagnostic purposes may also be included in the study.
Key exclusion criteria (5 listed)
- Severe comorbidities (AST, ALT, serum creatinine > 3 times the upper limit of normal).
- Pregnancy or women of childbearing potential.
- Anticoagulation which cannot be stopped for 5-7 days.
- Hepatitis B, C or HIV.
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures.
Time frame: 6 weeks
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 26 Jul 2018.
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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.
Roberto Bolli, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Louisville at 1 site in United States.
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 2 inclusion and 5 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 26 Jul 2018. 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 United States. 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?
Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.