Carotid Atherosclerosis Clinical Trial
— ELLIPSEOfficial title:
The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.
Verified date | November 2023 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trail is to compare the differences in carotid plaque Treg cells' gene signature for activation, proliferation, and suppressive function using scRNA-seq in patients treated with IL-2 compared to control.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Presence of carotid stenosis on either ultrasound or CT scan. - Planned to undergo carotid endarterectomy. Exclusion Criteria: - Autoimmune disease - Any regular immunosuppressive treatment [Inhaled or topical steroids are permissible] - Modified Rankin Scale score of =4 at screening - Known active hepatic disease or alanine aminotransferase (ALT) > 2xULN - Severe chronic kidney disease (defined as eGFR < 30 ml/min/1.73m2) - Allergy or intolerance to aldesleukin - Signs or symptoms of active infection - History of human immunodeficiency virus (HIV), hepatitis B or C - Current malignancy requiring active treatment - Vaccine within 4 weeks prior to screening or plans for vaccination during study period - Women of child-bearing potential and pregnancy - Women who are breast-feeding - Clinically relevant medical or surgical conditions that, in the opinion of the |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrookes Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Other immune cell and vascular smooth muscle cell gene expression | As per primary outcome measure but in immune cells and vascular smooth muscle cells (excluding Treg & Teff cells). Differential gene expression will be assessed using standard techniques (Z-Score) | Time of surgery | |
Other | Ligand-receptor interactions. | Differential regulation of ligand-receptor interactions between control and IL-2 treated cells will be identified by comparing single-cell/single-cell ligand-receptor interaction scores for the two groups. This measure is descriptive in nature. | Time of surgery | |
Other | T-Cell receptor profile | Difference in TCR clonality in plaques between the two groups will be assessed from clonotypes based on identical V-J gene usage and identical CDR3 junctions. | Time of surgery | |
Other | Inflammatory pathway activation. | Activation of inflammatory pathways both at plaque and systemic level. Assess for enrichment of genes involved in inflammatory pathways - enrichment score. | Time of surgery | |
Primary | Difference in gene expression in Tregs | Comparing differential gene expression using scRNA-seq technologies, from isolated Tregs from carotid plaques from the two patient groups (IL-2 treatment and control). Differential gene expression will be assessed using standard techniques (Z-Score) | Time of surgery | |
Secondary | Difference in gene expression in Teff cells. | Comparing differential gene expression using scRNA-seq technologies, from isolated Teffs from carotid plaques from the two patient groups (IL-2 treatment and control). Differential gene expression will be assessed using standard techniques (Z-Score) | Time of surgery | |
Secondary | Immune cell gene signature, in plaque and blood. | Difference in immune cell gene signature will be compared using scRNA-seq in both plaque and blood samples, and further compared between IL-2 and control groups. Comparative analysis will be completed using gene set enrichment analysis (Enrichment Score). | Time of surgery | |
Secondary | Difference in gene expression patterns in Treg & Teff cells. | Comparison between Treg and Teff cells collected at baseline and day of surgery will be compared between IL-2 and control groups. Differential gene expression will be assessed using standard techniques (Z-Score) | Baseline and at time of surgery |
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