A Study to Evaluate Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis


About this study

The purpose of this study is to evaluate the safety and effectiveness of CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amir Lerman, M.D.

Closed for enrollment

Contact information:

Amir Lerman M.D.

(507) 255-6670


More information


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