Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

How safe and effective are CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED)?

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Lenograstim; Sargramostim

Criteria

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