CLBS16 for Coronary Microvascular Dysfunction

Condition: Coronary microvascular dysfunction

Eligibility

Key Inclusion Criteria:

  • At least 18 years old
  • History of effort-induced anginal symptoms and currently experiencing angina at least 3 times per week, despite maximally tolerated doses of medications thought to positively impact patients with coronary microvascular dysfunction (CMD)
  • Diagnosis of CMD within 180 days prior to the first screening

Key Exclusion Criteria:

  • Myocardial infarction within 90 days prior to consent or between consent and treatment with CLBS16
  • Evidence of obstructive heart disease on screening angiogram or within 6 months prior to consent
  • Pregnant or lactating
Study Name

A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease (IRB no. 00001042)

Summary

This study focuses on individuals who have been diagnosed with a type of heart disease that affects the flow of blood through the tiny coronary arteries of the heart (coronary microvascular dysfunction), causing angina (chest pain). Patients who still experience chest pain despite stable medical treatment may be eligible for this study.

The study will evaluate an investigational drug called CLBS16, which is made of the body’s CD34+ cells, a special type of cell that may help to repair the tiny blood vessels in the body. These CD34+ cells are taken from the patient’s own blood (“autologous” cells). Researchers aim to determine whether autologous CD34+ cells that are injected into an artery in the heart are safe and effective at reducing chest pain symptoms and increasing the duration of time that the patient can exercise, thereby helping to improve overall quality of life. Participants will be randomly assigned to one of two treatment groups: active treatment (CD34+ cells) or placebo (no CD34+ cells).

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