Tolerance to NeuroEPO in Parkinson Disease

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment strategies in Parkinson's disease (PD) can improve a patient's quality of life but cannot stop the progression of PD. The investigators are looking for different alternatives that modify the natural course of the disease and recent research has demonstrated the neuroprotective properties of erythropoietin. In Cuba, the Center for Molecular Immunology (CIM) is a cutting edge scientific center where the recombinant form (EPOrh) and recombinant human erythropoietin with low sialic acid (NeuroEPO) are produced.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Center for Neurological Restoration, Cuba
• Collaborators: Center of Molecular Immunology, Cuba; University of Electronic Science and Technology of China

Criteria

Inclusion Criteria:

• Patient who fulfilled the London Brain Bank's operational criteria for PD

• Willing to participate in the study;

• ≥1 year since disease onset;

• Good response to antiparkinsonian treatment with levodopa (>30% change in motor score on the motor section of the Unified Parkinson's Disease

• no prior poly globulin (hematocrit ≤50%);

Exclusion Criteria:

• Refusal to participate;

• Known hypersensitivity to products derived from eukaryotes or hypersensitivity to human albumin;

• Pregnancy or breastfeeding;

• Hypertension;

• Immunosuppressant, androgen or anabolic steroid treatment in the month prior to recruitment;

• Sepsis or active infection;

• Active acute or chronic inflammatory diseases;

• Haematological diseases, such as sickle cell disease, myelodysplastic syndromes, active clotting or bleeding disorders;

• Malignant tumor or cancer treatment;

• Alcoholism or drug addiction in the two years prior to inclusion assessment.

• Significant cognitive decline as measured by clinical assessment, DRS (Dementia Rating Scale) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).