NCT03471611

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

A Phase 1, Feasibility Study Testing the Safety and Feasibility of Intracoronary CD34+ Cell Administration on Coronary Endothelial Function in Patients With Early Coronary Atherosclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open label, phase I study to determine safety and efficacy of CD34+ cells in the treatment and management of CED and early atherosclerosis. Coronary endothelial function will be assessed in all patients by the administration of intracoronary acetylcholine. Patients with endothelial dysfunction who meet study inclusion criteria will receive granulocyte cell stimulating factor (G-CSF), followed by apheresis. The mobilized peripheral cell product will be processed for selection of CD34+ stem cells, and the purified CD34+ cells will be administered intracoronary during cardiac catheterization. The patients will undergo repeat endothelial function assessment 6 months post-procedure, as well as clinical assessments as described below either via in-person assessment by a nurse or physician, or via phone-call using a standardized questionnaire at 1, 3, and 6 month follow-up visits. At one month, the patient will undergo basic laboratory testing including troponin levels, complete blood count (CBC), electrolyte panel, liver function testing and ECG. At 3 months, the patients will receive a phone follow-up by the study coordinator who will assess the patient for any clinical deterioration or significant worsening in symptoms. At 6 months, the patients will return for a clinical visit, which will include physical examination, basic laboratory testing and follow-up acetylcholine study with angiography to assess for change in endothelial function. The first three patients will be sequentially enrolled, and subsequent enrollment will be held until one month follow-up. Provided there are no safety concerns at this time, enrollment will continue.

Conditions

• Atherosclerosis, Coronary

Interventions

Type	Name	Description
DRUG	Autologous CD34+ Cells	The dose will be 1x10\^5 cells/kg, injected at the rate of 10 ml/min
DRUG	Granulocyte Colony-Stimulating Factor (G-CSF)	5mg/kg twice daily

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-10-02
• Completion: 2020-10-02
• First posted: 2018-03-20
• Last updated: 2022-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study