Status:
COMPLETED
Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis
Lead Sponsor:
Mayo Clinic
Conditions:
Atherosclerosis, Coronary
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
How safe and effective are CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED)?
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03471611
Start Date
June 15 2018
End Date
October 2 2020
Last Update
February 7 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905