Ischemic Heart DiseasePhase 1NCT00426868
A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
A Phase 1 study testing Direct injection of ADRCs into the Left Ventricle in people with Ischemic Heart Disease and Coronary Arteriosclerosis, run by Cytori Therapeutics at 4 sites in 3 countries.
Trial summary
The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Arteriosclerosis, Cardiovascular Disease
- What is being tested?
- Direct injection of ADRCs into the Left Ventricle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jan 2007to Mar 2012
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Males or females 20 to 75 years of age, inclusive
- Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area
- Hemodynamic stability
- Ability to undergo liposuction
- Ability to walk on a treadmill
- Negative urine pregnancy test (females only).
Who cannot join
- Unstable angina
- Serum creatinine >2.5 mg/dL
- Planned or scheduled staged treatment of CAD or other interventional or surgical procedures
- Cardiogenic shock
- History of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia.
- Vascular anatomy that precludes cardiac catheterization
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- Peripheral artery disease that precludes insertion of an 8 Fr sheath
- Severe valvular disease
- Pregnant or nursing females
- Known and relevant allergies or sensitivities
- Life expectancy <1 year
- Participation in any other clinical research study that has not reached its primary endpoint or otherwise would interfere with the subject's participation in this study
- Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
Erasmus University Medical Centrum, Thorax Center
Rotterdam
University of Utrecht Medical Center
Utrecht
About this study
Official title: A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial
The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.
Read the detailed description
Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.
The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.
- Conditions
- Ischemic Heart Disease, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease, Coronary Artery Disease
- Being tested
- Direct injection of ADRCs into the Left Ventricle, Direct injection of placebo into the Left Ventricle
- Keywords
- ADRC, Stem Cells, chronic ischemia, heart disease, coronary artery disease, inducible reversible ischemia
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct injection of ADRCs into the Left VentricleOther
Dose escalation
Direct injection of placebo into the Left VentricleOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Direct injection of ADRCs into the Left Ventricle |
| Placebo | Placebo comparator | Not described Receives: Other: Direct injection of placebo into the Left Ventricle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Measured: Up to 36 months
Secondary outcomes (1)
Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2012
- Study completionMar 2012
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 Heart DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander M Milstein, MD, Study director, Cytori Therapeutics, IncFrancisco J Fernández-Avilés, MD, PhD, FACC, FESC, Principal investigator, Hospital G.U. Gregorio MarañónEmerson C Perin, MD, PhD, Principal investigator, Texas Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426868
- Sponsor's protocol ID
- PRECISE-01
- Status last verified
- Aug 2013
- First submitted
- 23 Jan 2007
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perin EC, Sanz-Ruiz R, Sanchez PL, Lasso J, Perez-Cano R, Alonso-Farto JC, Perez-David E, Fernandez-Santos ME, Serruys PW, Duckers HJ, Kastrup J, Chamuleau S, Zheng Y, Silva GV, Willerson JT, Fernandez-Aviles F. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. Am Heart J. 2014 Jul;168(1):88-95.e2. doi: 10.1016/j.ahj.2014.03.022. Epub 2014 Apr 5.
PubMed 24952864
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial
- ClinicalTrials.gov ID
- NCT00426868
- Acronym / sponsor ID
- PRECISE-01
- Conditions
- Ischemic Heart Disease, Coronary Arteriosclerosis, Cardiovascular Disease, Coronary Disease, Coronary Artery Disease
- Keywords
- ADRC, Stem Cells, chronic ischemia, heart disease, coronary artery disease, inducible reversible ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Jan 2007 (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 establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.
Detailed description
Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.
The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Direct injection of ADRCs into the Left Ventricle |
| Placebo | Placebo comparator | Other: Direct injection of placebo into the Left Ventricle |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide written informed consent
- Males or females 20 to 75 years of age, inclusive
- Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area
- Hemodynamic stability
- Ability to undergo liposuction
Key exclusion criteria (13 listed)
- Unstable angina
- Serum creatinine >2.5 mg/dL
- Planned or scheduled staged treatment of CAD or other interventional or surgical procedures
- Cardiogenic shock
- History of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia.
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 |
|---|---|---|
| Direct injection of ADRCs into the Left VentricleDose escalation | Other | Treatment |
| Direct injection of placebo into the Left Ventricle | Other | Placebo |
Primary outcome
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Time frame: Up to 36 months
1 secondary outcome
Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography
Time frame: Up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Derived from this study: PubMed 24952864Perin EC, Sanz-Ruiz R, Sanchez PL, Lasso J, Perez-Cano R, Alonso-Farto JC, Perez-David E, Fernandez-Santos ME, Serruys PW, Duckers HJ, Kastrup J, Chamuleau S, Zheng Y, Silva GV, Willerson JT, Fernandez-Aviles F. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. Am Heart J. 2014 Jul;168(1):88-95.e2. doi: 10.1016/j.ahj.2014.03.022. Epub 2014 Apr 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.
Alexander M Milstein, MD study director
Cytori Therapeutics, Inc
Francisco J Fernández-Avilés, MD, PhD, FACC, FESC principal investigator
Hospital G.U. Gregorio Marañón
Emerson C Perin, MD, PhD principal investigator
Texas Heart Institute
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Direct injection of ADRCs into the Left Ventricle in people with Ischemic Heart Disease and Coronary Arteriosclerosis, run by Cytori Therapeutics at 4 sites in 3 countries.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Denmark, Spain. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE) (time frame: Up to 36 months). 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 NCT00426868, 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 28 Aug 2013.