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

NCT03471611 | Completed Phase 1 FDA Drug

• 1 other identifier: 17-005743
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atherosclerosis, Coronary

Outcome Measures

Primary Outcomes (3)

• Number of subjects experiencing adverse events

  12 months

• Number of subjects experiencing serious adverse events

  12 months

• Number of subjects experiencing Major Adverse Cardiovascular Events (MACE)

  The most commonly reported major cardiovascular adverse events (MACE) include myocardial infarction, heart failure, percutaneous cardiac intervention, coronary artery bypass grafting, malignant dysrhythmia, cardiac shock, implantable cardiac defibrillator, malignant dysrhythmia and death.

  12 months

Study Arms (1)

Subjects with Endothelial Dysfunction

EXPERIMENTAL

Subjects will be treated with Granulocyte Colony-Stimulating Factor (G-CSF) for 5 days at a dose of 5 mg/kg twice daily. When count of CD34+ cells is sufficient, the CD34+ cells will be collected by apheresis. Autologous CD34+ cells will be injected into the subjects at a rate of 10 ml/min.

Drug: Autologous CD34+ Cells; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

Interventions

Autologous CD34+ Cells DRUG

The dose will be 1x10\^5 cells/kg, injected at the rate of 10 ml/min

Subjects with Endothelial Dysfunction

Granulocyte Colony-Stimulating Factor (G-CSF) DRUG

5mg/kg twice daily

Also known as: Neupogen, Neulasta

Subjects with Endothelial Dysfunction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of coronary endothelial dysfunction based on coronary angiogram and acetylcholine comprehensive coronary physiology study
• Able to provide informed written consent and willing to participate in all required study follow-up assessments

You may not qualify if:

• Acute coronary syndrome or continuous/ongoing chest pain - unremitting and unresponsive to nitroglycerin or rest - persisting 4 or more days before stent placement. If the chest pain syndrome is transient and/or intermittent - even if it began more than 3 days prior to admission - the patient is not excluded.
• Subjects in cardiogenic shock (systolic pressure \< 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
• Subjects unable to receive antiplatelet agents (e.g. aspirin, clopidogrel, ticlopidine,prasugrel, etc).
• Abnormal laboratory values (Hgb \<11 mg/dL; glomerular filtration rate (GFR)\<50; liver function tests (LFTs)\>2x upper limit of normal).
• Subjects receiving warfarin who have an international normalized ratio (INR) \>2 at the end of the screening phase or with major bleeding requiring active transfusion support.
• Subjects with severe cardiac valvular disease expected to undergo surgery within 1 year.
• Subjects with known severe immunodeficiency states (AIDS).
• Significant coronary artery disease on coronary angiogram
• Cirrhosis requiring active medical management.
• Malignancy requiring active treatment (except basal cell skin cancer).
• Subjects with documented active alcohol and /or other substance abuse.
• Females of child bearing potential unless a pregnancy test is negative within 7 days of the bone marrow harvest.
• Re-occlusion of the infarct related artery (IRA) prior to the infusion procedure.
• Planned revascularization intervention during the next 6 months. (A second PCI can be performed if done prior to qualifying cardiovascular magnetic resonance imaging (CMR) at least 96 hours post primary PCI).
• Participation in an ongoing investigational trial.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 34923853 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

betibeglogene autotemcel; Granulocyte Colony-Stimulating Factor; Filgrastim; pegfilgrastim

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Amir Lerman

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 20, 2018
• Study Start: June 15, 2018
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

US (1)