Coronary ArteriosclerosisPhase 1STARNCT00463853
Stem Cell Therapy as Adjunct to Revascularization
A Phase 1 study testing Autologous stem cell therapy, CABG and CMRI in people with Coronary Arteriosclerosis and Coronary Artery Bypass Graft, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether it is safe to receive an injection of your own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary artery bypass graft (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Coronary Artery Bypass Graft, Myocardial Revascularization
- What is being tested?
- Autologous stem cell therapy, CABG and CMRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- Age 18 or older
- Ability to give informed consent
- Have documented CAD and depressed LV function (EF <40%) that is felt to be appropriately treated with surgical revascularization by the VA Salt Lake City Health Care System Cardiothoracic Surgery team and in accordance with the published 2004 ACC/AHA Guideline Update for Coronary Artery Bypass Graft Surgery; specifically, in accordance with the described indication for CABG in patients with Poor LV Function (see below).
- Class I
- CABG should be performed in patients with poor LV function who have significant left main coronary artery stenosis. (Level of Evidence: B)
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- CABG should be performed in patients with poor LV function who have left main equivalent:
- significant (greater than or equal to 70%) stenosis of the proximal LAD and proximal left circumflex artery. (Level of Evidence: B)
- CABG should be performed in patients with poor LV function who have proximal LAD stenosis with 2- or 3-vessel disease. (Level of Evidence: B)
- Class IIa
- CABG may be performed in patients with poor LV function with significant viable noncontracting, revascularizable myocardium and without any of the above anatomic patterns. (Level of Evidence: B)
- NHYA/CCA Class I or higher
- Abnormal cardiac wall segment on preoperative data
- Acutely stable myocardium without evidence of cardiogenic shock or evolving myocardial infarction
Who cannot join
- EF 40%
- CAD not amenable to CABG
- ACC/AHA Poor LV Function Class III - CABG should not be performed in patients with poor LV function without evidence of intermittent ischemia and without evidence of significant revascularizable viable myocardium. (Level of Evidence: B) Evidence of intermittent ischemia is defined clinically by Cardiovascular Disease Classification (see chart above). Objectively, this can be demonstrated by various modalities that can demonstrate ischemic myocardium. Such modalities include SCA, Echo, CMRI, and radionucleotide imaging.
- Patients undergoing cardiac re-operation
- Patients with operable valvular disease
- Patients with preexisting malignant arrhythmia
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- Patients with preexisting systemic malignancy
- Patients with a contraindication to MRI
- Presence of ongoing local or systemic infection
- Participation in another clinical trial
- Emergency operation
- Preoperative cardiogenic shock or evolving myocardial infarction
- ASA Class V or contraindication to general anesthesia
- Pregnancy
- Prisoner
- Active history of alcohol or substance abuse
- Active psychiatric history leading to potential for poor study participation and follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, 84148
About this study
Official title: Stem Cell Therapy as Adjunct to Revascularization: STAR
The purpose of this study is to determine whether it is safe to receive an injection of your own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary artery bypass graft (CABG).
Read the detailed description
The experimental design will be a Phase I safety trial in which all subjects from the VA Salt Lake City Health Care System presenting with CAD and associated depressed LV function requiring myocardial surgical revascularization will be eligible for enrollment. Patients enrolled in the study will receive autologous BM-MNC as adjunct to CABG. The primary outcome measure will be safety as measured by the incidence of postoperative Serious Adverse Events (SAE) and Adverse Events (AE). The secondary outcome measures will be LV function, myocardial perfusion, and clinical improvement. The trial will have one experiment with one patient group. Group 1 (n=15) will follow standard Phase I dose escalation curve on a magnitude of 0.5 log increase after every third patient. Dose escalation will continue until a dosage of 1 x108 cells/pt is reached or maximum tolerated dose equivalent (MTDE) is identified. Cellular therapeutic products such as BM-MNCS do not possess the same pharmacologic profile as small molecule drugs, and thus, do not possess predictable metabolic activity and metabolite production, as do traditional pharmaceuticals. This can make the identity of a maximum tolerated dose somewhat difficult. We are therefore using the term MTDE instead of MTD to indicate a cell dosage that is consistent with clinical morbidity beyond obvious clinical benefit. The characteristics identifying a MTDE could be any adverse event felt to be related to the actual cell dosage or its escalation. Although unlikely, MTDE events could include microembolic phenomena, hematoma at the injection site, obvious myocardial congestion or ischemia at the injection site.
- Being tested
- Autologous stem cell therapy, CABG, CMRI
- Keywords
- Bone Marrow Cells, Cardiovascular Surgery, Coronary Artery Bypass Graft, Phase I Study, Stem Cells
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous stem cell therapyProcedure or surgery
CABGProcedure or surgery
CMRIRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | direct intramyocardial injection of cells as adjunct to CABG Receives: Procedure: Autologous stem cell therapy; Procedure: CABG; Radiation: CMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be safety as measured by the incidence of postoperative serious adverse events (SAE) and adverse events (AE).
Measured: 1 year
Secondary outcomes (4)
Ejection fraction measured by CMRI
Measured: at baseline, 3 & 6 months
Echo
Measured: at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year
Myocardial perfusion measured by gadolinium CMRI
Measured: at baseline, 3 & 6 months
Exercise tolerance testing
Measured: at baseline, 1 month, 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionOct 2009
Why it stopped: inability to recruit due to administrative difficulties at the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- G. Russell Reiss, MD, Study chair, VA Salt Lake City Health Care System, Salt Lake City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463853
- Sponsor's protocol ID
- CLNB-017-04S
- Acronym
- STAR
- Status last verified
- Jun 2014
- First submitted
- 17 Apr 2007
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stem Cell Therapy as Adjunct to Revascularization: STAR
- ClinicalTrials.gov ID
- NCT00463853
- Acronym / sponsor ID
- STAR / CLNB-017-04S
- Keywords
- Bone Marrow Cells, Cardiovascular Surgery, Coronary Artery Bypass Graft, Phase I Study, Stem Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to recruit due to administrative difficulties at the site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Utah
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 20 Apr 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 determine whether it is safe to receive an injection of your own bone marrow adult stem cells (autologous BM-MNC) to your heart wall during coronary artery bypass graft (CABG).
Detailed description
The experimental design will be a Phase I safety trial in which all subjects from the VA Salt Lake City Health Care System presenting with CAD and associated depressed LV function requiring myocardial surgical revascularization will be eligible for enrollment. Patients enrolled in the study will receive autologous BM-MNC as adjunct to CABG. The primary outcome measure will be safety as measured by the incidence of postoperative Serious Adverse Events (SAE) and Adverse Events (AE). The secondary outcome measures will be LV function, myocardial perfusion, and clinical improvement. The trial will have one experiment with one patient group. Group 1 (n=15) will follow standard Phase I dose escalation curve on a magnitude of 0.5 log increase after every third patient. Dose escalation will continue until a dosage of 1 x108 cells/pt is reached or maximum tolerated dose equivalent (MTDE) is identified. Cellular therapeutic products such as BM-MNCS do not possess the same pharmacologic profile as small molecule drugs, and thus, do not possess predictable metabolic activity and metabolite production, as do traditional pharmaceuticals. This can make the identity of a maximum tolerated dose somewhat difficult. We are therefore using the term MTDE instead of MTD to indicate a cell dosage that is consistent with clinical morbidity beyond obvious clinical benefit. The characteristics identifying a MTDE could be any adverse event felt to be related to the actual cell dosage or its escalation. Although unlikely, MTDE events could include microembolic phenomena, hematoma at the injection site, obvious myocardial congestion or ischemia at the injection site.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Autologous stem cell therapy, Procedure: CABG, Radiation: CMRIdirect intramyocardial injection of cells as adjunct to CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Veteran
- Age 18 or older
- Ability to give informed consent
- Have documented CAD and depressed LV function (EF <40%) that is felt to be appropriately treated with surgical revascularization by the VA Salt Lake City Health Care System Cardiothoracic Surgery team and in accordance with the published 2004 ACC/AHA Guideline Update for Coronary Artery Bypass Graft Surgery; specifically, in accordance with the described indication for CABG in patients with Poor LV Function (see below).
- Class I
Key exclusion criteria (17 listed)
- EF 40%
- CAD not amenable to CABG
- ACC/AHA Poor LV Function Class III - CABG should not be performed in patients with poor LV function without evidence of intermittent ischemia and without evidence of significant revascularizable viable myocardium. (Level of Evidence: B) Evidence of intermittent ischemia is defined clinically by Cardiovascular Disease Classification (see chart above). Objectively, this can be demonstrated by various modalities that can demonstrate ischemic myocardium. Such modalities include SCA, Echo, CMRI, and radionucleotide imaging.
- Patients undergoing cardiac re-operation
- Patients with operable valvular disease
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 |
|---|---|---|
| Autologous stem cell therapy | Procedure or surgery | Arm 1 |
| CABG | Procedure or surgery | Arm 1 |
| CMRI | Radiation | Arm 1 |
Primary outcome
The primary outcome measure will be safety as measured by the incidence of postoperative serious adverse events (SAE) and adverse events (AE).
Time frame: 1 year
4 secondary outcomes
Ejection fraction measured by CMRI
Time frame: at baseline, 3 & 6 months
Echo
Time frame: at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year
Myocardial perfusion measured by gadolinium CMRI
Time frame: at baseline, 3 & 6 months
Exercise tolerance testing
Time frame: at baseline, 1 month, 3 months, 6 months, and 1 year
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 11 Jun 2014.
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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.
G. Russell Reiss, MD study chair
VA Salt Lake City Health Care System, Salt Lake City
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 Autologous stem cell therapy, CABG and CMRI in people with Coronary Arteriosclerosis and Coronary Artery Bypass Graft, run by US Department of Veterans Affairs 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 14 inclusion and 17 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 11 Jun 2014. 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.
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?
The primary outcome measure will be safety as measured by the incidence of postoperative serious adverse events (SAE) and adverse events (AE). (time frame: 1 year). 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 11 Jun 2014.