Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03471611
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2018-03-14
Brief Title:
Study of Intracoronary CD34 Cell Administration in Patients With Early Coronary Atherosclerosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
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
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None