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

Early Phase 1

• Conditions: Lipid Metabolism, Inborn Errors
• Interventions: Biological: Anti-oxLDL IgM antibody

• Registration Number: NCT02707211
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2016-01-20
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-15
• Study Start: 2016-06
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-oxLDL IgM antibodies	Anti-oxLDL IgM antibody	administration Anti-oxLDL IgM antibodies

Primary Outcome Measures

Name	Time	Method
The level of inflammation	4 weeks

Secondary Outcome Measures

Name	Time	Method
Levels of lysosomal enzymes	4 weeks
the level of cholesterol metabolism	4 weeks

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-brabant, Belgium