Chronic Ischemic Heart DiseasePhase 1NCT03043742
Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease
A Phase 1 study testing Bone Marrow Derived Autologous CD133+ Selected Cell Product in people with Chronic Ischemic Heart Disease, run by Michael Sekela at 1 site in United States.
Trial summary
Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ischemic Heart Disease
- What is being tested?
- Bone Marrow Derived Autologous CD133+ Selected Cell Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2016to 12 Nov 2020
- 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
- Presence of at least two vessel coronary artery disease not amenable to direct revascularization
- Area of interest defined as part of free left ventricular vall with reduced contractility
- Demonstration of reduced perfusion in the area of interest (>30% of free wall)
- Global ejection fraction 30-45% with symptoms class >_ II on the NYHA scale
- Significant refractory angina defined as symptoms class >_ III that are refractory to maximal medical and anti-angina therapy
- Expected survival of at least two years
Who cannot join
- Any condition that prevents successful stem cell collection or application, e.g. systemic infection, puncture for stem cell collection impossible
- Any condition that may adversely affect bone marrow such as malignancy or prior irradiation to the pelvic bone
- Mitral valve insufficiency > moderate grade
- History of ventricular arrhythmias not controlled by medication and/or AICD
- Need for additional heart surgery (i.e. valve replacement)
- Emergency or salvage operation defined as within 48 hours of diagnosis
Show all 14Show fewer
- Evidence of left ventricular thrombus
- Previous heart surgery within the last 6 months
- Increased Troponin T (> 3X ULN) in patients with unstable angina at time of intervention
- History of symptomatic carotid disease within the last 3 months prior to study intervention
- Ejection fraction < 30%
- End stage renal disease
- Untreatable cancer, current or within preceding 5 years
- Severe COPD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Healthcare
Lexington, Kentucky, 40536
About this study
Official title: Prospective Controlled Trial of Intra-Myocardial Infusion of Bone Marrow Derived Autologous CD133+ Selected Cells During Trans-Myocardial Laser Revascularization (TMR) in Patients With Chronic Ischemic Heart Disease
Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells.
Read the detailed description
Multiple case experiences and studies have been published reviewing clinical experiences with Carbon Dioxide Trans-Myocardial Laser Revascularization (TMR) and autologous bone marrow derived cell application. These experiences have demonstrated perfusion improvements, ejection fraction improvements and improvements in angina or heart failure symptoms. The investigators elected to examine the use of CD133 positive (CD133+) BM-derived stem cells because of their pluripotent nature and the fact that during the CD133 selection process inflammatory cells present in the bone marrow are being discarded. CD133+ is a recently discovered marker for more primitive bone marrow derived multipotent stem and endothelial progenitor cells and is of particular interest in studies directed to therapeutic angiogenesis, as these cells have been shown to differentiate into endothelial and myogenic cell lines. Multiple studies have utilized BM derived cells for myocardial regeneration. Patients who received CD133+ cells showed improved perfusion at injection sites of stem cells leading to a significant increase in volume of left ventricular ejection fraction, regional wall motion in the infarct zone, and a reduction in end systolic left ventricular volume.
- Conditions
- Chronic Ischemic Heart Disease
- Being tested
- Bone Marrow Derived Autologous CD133+ Selected Cell Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Derived Autologous CD133+ Selected Cell ProductDrug
Also called Stem cell
Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization
| Study group | Role | What they receive |
|---|---|---|
| Phase I Open Label | Experimental | open label bone marrow derived autologous CD133+ selected stem cell application in patients receiving trans-myocardial laser revascularization to improve regional myocardial function as detailed below:
Drug: CD133+ selected stem cells Dosage: Single injection of 0.1-0.2 ml around each laser channel Frequency: 10-20 channels Duration: Trans-Myocardial Revascularization Receives: Drug: Bone Marrow Derived Autologous CD133+ Selected Cell Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events
Major adverse cardiac event and adverse events defined in the common toxicity criteria
Measured: Assess from Procedure through 12 months
Secondary outcomes (9)
Change in left ventricular ejection fraction compared to baseline
Measured as a percentage by Echocardiography
Measured: Assessed at baseline, 6 months, and 12 months
Change in myocardial regional function compared to baseline
Measured by nuclear scanning.
Measured: Assessed at baseline and 6 months
Change in myocardial regional viability compared to baseline
Measured by nuclear scanning.
Measured: Assessed at baseline and 6 months
Change in distance walked compared to baseline
Measured in feet during a 6 minute walk test
Measured: Assessed at baseline, 3 months, 6 months, and 12 months
Change in quality of life associated with heart failure compared to baseline
Measured using the Kansas City Cardiomyopathy Questionnaire.
Measured: Assessed at baseline, 3 months, 6 months, and 12 months
Change in class of angina compared to baseline
Measured using the Canadian Cardiovascular Society Grading Scale.
Measured: Assessed at baseline, 3 months, 6 months, and 12 months.
Change in class of heart failure compared to baseline
Measured using the New York Heart Association Questionnaire
Measured: Assessed at baseline, 3 months, 6 months, and 12 months.
Change in regional left ventricular wall motion compared to baseline
Measured using echocardiogram.
Measured: Assessed at baseline, 6 months, and 12 months
Change in quality of life associated with angina compared to baseline
Measured using the Seattle Angina Questionnaire
Measured: Assessed at baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start12 Jul 2016
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Sekela
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Sekela, University of Kentucky
- Investigators
- Michael Sekela, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043742
- Sponsor's protocol ID
- 15-1051
- Status last verified
- Dec 2020
- First submitted
- 17 Jun 2016
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: to be determined per principal investigator and statistician
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Trial of Intra-Myocardial Infusion of Bone Marrow Derived Autologous CD133+ Selected Cells During Trans-Myocardial Laser Revascularization (TMR) in Patients With Chronic Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT03043742
- Acronym / sponsor ID
- 15-1051
- Conditions
- Chronic Ischemic Heart Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Michael SekelaUniversity, hospital or other
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 6 Feb 2017 (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.
Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells.
Detailed description
Multiple case experiences and studies have been published reviewing clinical experiences with Carbon Dioxide Trans-Myocardial Laser Revascularization (TMR) and autologous bone marrow derived cell application. These experiences have demonstrated perfusion improvements, ejection fraction improvements and improvements in angina or heart failure symptoms. The investigators elected to examine the use of CD133 positive (CD133+) BM-derived stem cells because of their pluripotent nature and the fact that during the CD133 selection process inflammatory cells present in the bone marrow are being discarded. CD133+ is a recently discovered marker for more primitive bone marrow derived multipotent stem and endothelial progenitor cells and is of particular interest in studies directed to therapeutic angiogenesis, as these cells have been shown to differentiate into endothelial and myogenic cell lines. Multiple studies have utilized BM derived cells for myocardial regeneration. Patients who received CD133+ cells showed improved perfusion at injection sites of stem cells leading to a significant increase in volume of left ventricular ejection fraction, regional wall motion in the infarct zone, and a reduction in end systolic left ventricular volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I Open Label | Experimental | Drug: Bone Marrow Derived Autologous CD133+ Selected Cell Productopen label bone marrow derived autologous CD133+ selected stem cell application in patients receiving trans-myocardial laser revascularization to improve regional myocardial function as detailed below: Drug: CD133+ selected stem cells Dosage: Single injection of 0.1-0.2 ml around each laser channel Frequency: 10-20 channels Duration: Trans-Myocardial Revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of at least two vessel coronary artery disease not amenable to direct revascularization
- Area of interest defined as part of free left ventricular vall with reduced contractility
- Demonstration of reduced perfusion in the area of interest (>30% of free wall)
- Global ejection fraction 30-45% with symptoms class >_ II on the NYHA scale
- Significant refractory angina defined as symptoms class >_ III that are refractory to maximal medical and anti-angina therapy
Key exclusion criteria (14 listed)
- Any condition that prevents successful stem cell collection or application, e.g. systemic infection, puncture for stem cell collection impossible
- Any condition that may adversely affect bone marrow such as malignancy or prior irradiation to the pelvic bone
- Mitral valve insufficiency > moderate grade
- History of ventricular arrhythmias not controlled by medication and/or AICD
- Need for additional heart surgery (i.e. valve replacement)
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 |
|---|---|---|
| Bone Marrow Derived Autologous CD133+ Selected Cell ProductAlso: Stem cellInjection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization | Drug | Phase I Open Label |
Primary outcome
Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events
Time frame: Assess from Procedure through 12 months
Major adverse cardiac event and adverse events defined in the common toxicity criteria
9 secondary outcomes
Change in left ventricular ejection fraction compared to baseline
Time frame: Assessed at baseline, 6 months, and 12 months
Change in myocardial regional function compared to baseline
Time frame: Assessed at baseline and 6 months
Change in myocardial regional viability compared to baseline
Time frame: Assessed at baseline and 6 months
Change in distance walked compared to baseline
Time frame: Assessed at baseline, 3 months, 6 months, and 12 months
Change in quality of life associated with heart failure compared to baseline
Time frame: Assessed at baseline, 3 months, 6 months, and 12 months
Change in class of angina compared to baseline
Time frame: Assessed at baseline, 3 months, 6 months, and 12 months.
Change in class of heart failure compared to baseline
Time frame: Assessed at baseline, 3 months, 6 months, and 12 months.
Change in regional left ventricular wall motion compared to baseline
Time frame: Assessed at baseline, 6 months, and 12 months
Change in quality of life associated with angina compared to baseline
Time frame: Assessed at baseline, 3 months, 6 months, and 12 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 11 Dec 2020.
- Individual participant dataSharing planned: No. to be determined per principal investigator and statistician
Related trials for Chronic Ischemic Heart Disease
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
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.
Michael Sekela, MD principal investigator
University of Kentucky
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 Bone Marrow Derived Autologous CD133+ Selected Cell Product in people with Chronic Ischemic Heart Disease, run by Michael Sekela 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 6 inclusion and 14 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 11 Dec 2020. 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 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?
Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events (time frame: Assess from Procedure through 12 months). 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 Dec 2020.