Physicians: If you have a patient who appears to meet the preliminary eligibility criteria below, please get in touch with us about possibly contributing to this trial: ClinicalTrials.gov (Identifier: NCT04614467)
- Men or women age ≥18
- History of effort-induced anginal symptoms and currently experiencing angina at least 3 times per week, despite maximally tolerated doses of antianginal medications, statins, ACE inhibitors, ARBs and other medications thought to positively impact subjects with CMD.
- Prior diagnosis of CMD based on CFR ≤ 2.5
- Peak CFR to intracoronary adenosine ≤ 2.5 at screening
- CCS class II, 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
- Any cardiovascular medical therapy must be at a stable dose for at least 30 days prior to screening and must be maintained at that dose throughout the duration of the study; cardiovascular therapy would generally include statins (unless not tolerated), ACE inhibitors, beta blockers, calcium channel blockers, and/or ranolazine (unless ineffective or not tolerated).
- Able to provide signed informed consent
- Myocardial infarction within 90 days prior to consent or between consent and treatment with CLBS16
- Prior evidence of obstructive heart disease including history of PCI and/or CABG
- Planned PCI 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
- LVEF < 30%
- Glomerular filtration rate <30 mL/min/1.73m2 (MDRD)
- Subject currently uses coumadin, dabigatran, apixaban, rivaroxaban, or edoxaban or plans to use one of these agents during the time frame of the trial
- Subject has serious hypersensitivity or a history of adverse reaction to GCSF or apheresis
- Subject has a known allergy to mouse proteins
- Subject tests positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Subject has active inflammatory disease or autoimmune disease, or is in a chronic immunosuppressive state
- Recent history of abuse or current abuser of alcohol or recreational drugs
- Subject is pregnant or lactating at the time of signing the consent
- Malignant neoplasm (other than adequately treated non-melanoma skin cancer or in situ cervical carcinoma) within 5 years prior to screening
- Subject has participated in another clinical study within 90 days prior to signing the informed consent or is scheduled to participate in another clinical study during the course of the study. Observational studies in which the subject did not receive treatment or did not undergo procedures which may compromise this study’s data integrity may be allowable following Sponsor approval.
- History of sickle cell disease
- Any other condition which, in the opinion of the investigator, may preclude the subject from safe participation in the study or compromise data integrity