Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes

Parkinson's Disease Clinical Trial

— LymphoEnergy  

Official title:

Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880033
• Other study ID #: 2010_29
• Secondary ID: 2010-A01216-33
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development.

The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo.

PBMC and platelets will be stored for future analyses.

Description:

The study collection of PBMC and platelets from 30 patient having Parkinson's disease 30 patients having Amyotrophic lateral sclerosis and 30 healthy controls.

The collection will be performed either by cytapheresis for half of the patient and by collecting the whole blood for the other half.

PBMC and platelets will be stored at minus 80°C. PBMC of patients and controls are exposed ex vivo to different pathological condition (mainly Hydrogen peroxide, menadione, hypoxia...) with and without deferiprone to analyse whether the level of oxidative stress (Reactive Oxygen Species and notably hydroxyl radical with hydroxypethidine probe with flow cytometry) is reduced under deferiprone (primary criterion. Secondary analyses will concern the level of iron, the energy metabolism (aerobic versus anaerobic and the level of Adenosine triphosphate production), the type of cell death (apoptosis, autophagy and new programmed cell death: Ferroptosis) and inflammation. Finally, the level of growth factors and their effectiveness will be studied from platelets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Parkinson's disease according to Movement Disorders Society criteria

• Amyotrophic Lateral Sclerosis according to El escorial criteria

• Age and sex matched healthy controls

Exclusion Criteria:

• Severe comorbidities (cancer, other degenerative diseases, hemopathy, inflammatory diseases)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Iron Overload
• Motor Neuron Disease
• Oxidative Stress
• Parkinson Disease
• Parkinson's Disease
• Sclerosis

Intervention

Drug:
• deferiprone
to test the action of deferiprone on lymphocytes from patients and controls ex vivo
• placebo
to control the action of placebo on lymphocytes from patients and controls ex vivo

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hydroxyl radical measured	hydroxypethidine probe with Fluorescence-activated cell sorting	12 months
Secondary	adenosine triphosphate production measured by seahorse	seahorse experimentation	12 months
Secondary	oxygen consumption measured by seahorse	seahorse experimentation	12 months
Secondary	free reactive iron (ferrous iron)	calceine assay	12 months
Secondary	lipid peroxidation measured by Fluorescence-activated cell sorting	flow cytometry with bodipy probe	12 months