Research Study: FREEDOM CLBS16-P02
Condition:
coronary artery disease
Study Sponsor: Caladrius
Study Investigator: Jay Traverse, MD
Study Contact:
info@mhif.org
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single administration of CLBS16 or placebo.
Eligibility Criteria:

Inclusion Criteria:

  • Men or women age ≥18
  • History of and currently experiencing angina at least 3 times per week
  • Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures
  • Peak CFR to intracoronary adenosine ≤ 2.5 at screening
  • Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
  • No obstructive coronary artery disease
  • On stable medical therapy for at least 30 days prior to enrollment
  • Must agree to use a reliable and acceptable method of contraception for the duration of participation
  • Written informed consent

Exclusion Criteria:

    • Myocardial infarction within 90 days
    • Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
    • Diagnosis of other specific cardiac disease
    • Must meet LVEF and GFR requirements
    • Current use of coumadin or DOACs
    • Hypersensitivity to GCSF, apheresis or study product components
    • Positive for HIV, hepatitis B or hepatitis C
    • Active inflammatory or autoimmune disease, or chronic immunosuppressive state
    • Drug abuse
    • Pregnant or lactating
    • Malignant neoplasm within 5 years
    • History of Sickle Cell Disease
    • Participation in another clinical study within 90 days prior to informed consent or concurrently with this study
    • Previous treatment with a CD34+ cell based therapy

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!