drugset

drugset / Trial / NCT03471611

Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis

NCT03471611 ↗

Phase 1 Completed 21 enrolled Mayo Clinic

NaSingle-groupOpen-labelTreatment

Summary

How safe and effective are CD34+ cell intracoronary injections for treating coronary endothelial dysfunction (CED)?

Timeline

Start: 2018-06-15
Primary completion: 2020-10-02
Completion: 2020-10-02

Publications

Corban MT, Toya T, Albers D, Sebaali F, Lewis BR, Bois J, Gulati R, Prasad A, Best PJM, Bell MR, Rihal CS, Prasad M, Ahmad A, Lerman LO, Solseth ML, Winters JL, Dietz AB, Lerman A. IMPROvE-CED Trial: Intracoronary Autologous CD34+ Cell Therapy for Treatment of Coronary Endothelial Dysfunction in Patients With Angina and Nonobstructive Coronary Arteries. Circ Res. 2022 Feb 4;130(3):326-338. doi: 10.1161/CIRCRESAHA.121.319644. Epub 2021 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Autologous CD34+ Cells	Cell therapy	100000 cells/kg	Intravenous
Background	Granulocyte-colony stimulating factor (G-CSF)	Protein / enzyme biologic	5 mg/kg	—

Indications