Clinical Trials

Inclusion Criteria:

• Men or women age ≥18.
• History of effort-induced anginal symptoms and currently experiencing angina at least 3 times per week.
• Coronary flow reserve to intracoronary adenosine ≤ 2.5 at screening.
• CCS class III or IV chronic refractory angina as evaluated by the site.
• No obstructive disease on coronary angiogram within 6 months prior to screening which includes any of the following: coronary artery disease defined as a coronary artery stenosis less than 40% in the left main coronary artery, or a stenosis 20% or greater but less than 50% in any other epicardial coronary artery.
• If subject is of childbearing potential, the subject must have a negative pregnancy test at screening and prior to mobilization and GCSF treatment, and prior to receiving treatment. The subject agrees to employ adequate birth control measures for the duration of the study. Acceptable methods of birth control are: oral contraceptive tablets, hormonal implant device, hormonal patch, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, partner vasectomy, or abstinence.
• Subject is willing and able to comply with the requirements of the protocol.
• Stable cardiovascular medical therapy for 30 days prior to screening and expected to remain stable throughout the study; cardiovascular therapy would generally include statin (unless not tolerated) ACE inhibitor, beta blocker, calcium channel blocker, and/or ranolazine (unless ineffective or not tolerated).
• Able to provide signed informed consent.

Exclusion Criteria:

• Myocardial infarction within 90 days prior to consent or between consent and treatment with CLBS16.
• Prior evidence of obstructive heart disease including history of Percutaneous Coronary Intervention (PCI) and/or Coronary Artery Bypass Grafting (CABG).
• Planned percutaneous coronary intervention or CABG.
• Diagnosis of other specific cardiac disease such as severe valvular heart disease including:
  • aortic valve area < 1.5
  • 3+ mitral regurgitation
  • 3+ aortic insufficiency
  • Hypertrophic cardiomyopathy
  • Coronary spasm as defined by more than 30% reduction in vessel diameter in response to acetylcholine
• Left ventricular ejection fraction (LVEF) < 30%.
• GFR <30 mL/min/1.73m2 (MDRD).