Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases

Immunization Against oxLDL in Patients With Lysosomal Lipid Diseases and Associated Metabolic Disorders

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02707211

Enrollment

Registered

2016-03-14

Start date

2016-06-30

Completion date

2017-02-28

Last updated

2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipid Metabolism, Inborn Errors

Brief summary

To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

Detailed description

Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.

Interventions

BIOLOGICALAnti-oxLDL IgM antibody

Immunization

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology) * Familial hypercholesterolemia, * NPB, * NPC * Partial lipodystrophy (PPARg mutations and laminin A/C mutations) * Intention to be treated and participate to the treatment - Written informed consent

Exclusion criteria

* Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome * Alcohol abuse (quantitative limit \>20g/day for men and \>10g for women) * Illiteracy * Patients younger than 10 years. * Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame
The level of inflammation	4 weeks

Secondary

Measure	Time frame
Levels of lysosomal enzymes	4 weeks
the level of cholesterol metabolism	4 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026