- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471611
Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis
February 4, 2022 updated by: Amir Lerman, Mayo Clinic
A Phase 1, Feasibility Study Testing the Safety and Feasibility of Intracoronary CD34+ Cell Administration on Coronary Endothelial Function in Patients With Early Coronary Atherosclerosis
How safe and effective are CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED)?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open label, phase I study to determine safety and efficacy of CD34+ cells in the treatment and management of CED and early atherosclerosis.
Coronary endothelial function will be assessed in all patients by the administration of intracoronary acetylcholine.
Patients with endothelial dysfunction who meet study inclusion criteria will receive granulocyte cell stimulating factor (G-CSF), followed by apheresis.
The mobilized peripheral cell product will be processed for selection of CD34+ stem cells, and the purified CD34+ cells will be administered intracoronary during cardiac catheterization.
The patients will undergo repeat endothelial function assessment 6 months post-procedure, as well as clinical assessments as described below either via in-person assessment by a nurse or physician, or via phone-call using a standardized questionnaire at 1, 3, and 6 month follow-up visits.
At one month, the patient will undergo basic laboratory testing including troponin levels, complete blood count (CBC), electrolyte panel, liver function testing and ECG.
At 3 months, the patients will receive a phone follow-up by the study coordinator who will assess the patient for any clinical deterioration or significant worsening in symptoms.
At 6 months, the patients will return for a clinical visit, which will include physical examination, basic laboratory testing and follow-up acetylcholine study with angiography to assess for change in endothelial function.
The first three patients will be sequentially enrolled, and subsequent enrollment will be held until one month follow-up.
Provided there are no safety concerns at this time, enrollment will continue.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of coronary endothelial dysfunction based on coronary angiogram and acetylcholine comprehensive coronary physiology study
- Able to provide informed written consent and willing to participate in all required study follow-up assessments
Exclusion Criteria:
- Acute coronary syndrome or continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest - persisting 4 or more days before stent placement. If the chest pain syndrome is transient and/or intermittent - even if it began more than 3 days prior to admission - the patient is not excluded.
- Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
- Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine,prasugrel, etc).
- Abnormal laboratory values (Hgb <11 mg/dL; glomerular filtration rate (GFR)<50; liver function tests (LFTs)>2x upper limit of normal).
- Subjects receiving warfarin who have an international normalized ratio (INR) >2 at the end of the screening phase or with major bleeding requiring active transfusion support.
- Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.
- Subjects with known severe immunodeficiency states (AIDS).
- Significant coronary artery disease on coronary angiogram
- Cirrhosis requiring active medical management.
- Malignancy requiring active treatment (except basal cell skin cancer).
- Subjects with documented active alcohol and /or other substance abuse.
- Females of child bearing potential unless a pregnancy test is negative within 7 days of the bone marrow harvest.
- Re-occlusion of the infarct related artery (IRA) prior to the infusion procedure.
- Planned revascularization intervention during the next 6 months. (A second PCI can be performed if done prior to qualifying cardiovascular magnetic resonance imaging (CMR) at least 96 hours post primary PCI).
- Participation in an ongoing investigational trial.
- Active or suspected bacterial infection requiring systemic intravenous antibiotics.
- Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator
- Inmates
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Subjects with Endothelial Dysfunction
Subjects will be treated with Granulocyte Colony-Stimulating Factor (G-CSF) for 5 days at a dose of 5 mg/kg twice daily.
When count of CD34+ cells is sufficient, the CD34+ cells will be collected by apheresis.
Autologous CD34+ cells will be injected into the subjects at a rate of 10 ml/min.
|
The dose will be 1x10^5 cells/kg, injected at the rate of 10 ml/min
5mg/kg twice daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects experiencing adverse events
Time Frame: 12 months
|
12 months
|
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Number of subjects experiencing serious adverse events
Time Frame: 12 months
|
12 months
|
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Number of subjects experiencing Major Adverse Cardiovascular Events (MACE)
Time Frame: 12 months
|
The most commonly reported major cardiovascular adverse events (MACE) include myocardial infarction, heart failure, percutaneous cardiac intervention, coronary artery bypass grafting, malignant dysrhythmia, cardiac shock, implantable cardiac defibrillator, malignant dysrhythmia and death.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 15, 2018
Primary Completion (ACTUAL)
October 2, 2020
Study Completion (ACTUAL)
October 2, 2020
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (ACTUAL)
March 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-005743
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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