CLBS16 for Coronary Microvascular Dysfunction

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).


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
  • Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CLBS16 DELIVERY BY INTRACORONARY OR RETROGRADE CORONARY SINUS ADMINISTRATION IN SUBJECTS WITH CORONARY MICROVASCULAR DYSFUNCTION AND WITHOUT OBSTRUCTIVE CORONARY ARTERY DISEASE

Details
Disease Type/Condition

Women's Heart Disease

Principal Investigator

Bairey-Merz, Noel

Co-Investigators

Janet Wei

Age Group

Adult

Phase

II

IRB Number

STUDY00001042

ClinicalTrials.gov ID

NCT04614467

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Women's Heart Disease

Principal Investigator

Bairey-Merz, Noel

Age Group

Adult

Phase

II

IRB Number

CLBS16-P02

ClinicalTrials.gov ID

NCT04614467

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?