A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease

Korábbi kezelés

• Any current or relevant previous history of serious, severe or unstable physical or psychiatric illness or medical disorder that may make the participant unlikely to fully complete the study (depression, anxiety, cognitive impairment or impulse control disorder)
• Previous intracranial surgery, including deep-brain stimulation
• Any use of immunosuppressive drugs
• Enrollment in other investigational drug trial or has completed any trial within the last 3 months

Más betegség

• Mild cognitive impairment of dementia (MOCA score < 26)
• The extent or severity of the disease is not measurable
• Pre-existing medical conditions such as bleeding disorders, septicemia, major cardiovascular, cerebrovascular or psychiatric disease
• Any active infectious disease of any nature, including clinically active viral infections (seropositive for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) and Syphilis
• History of seizures
• Substance abuse (recent history of alcohol abuse or other drugs such as barbiturates, cannabinoids and amphetamines)
• Signs of any malignant disease
• Any other condition which clinician regards as making patient unsuitable for trial

Laborértékek

• Clinically significant abnormal hematologic evaluation (blood count, partial thromboplastin time (PTT)), blood chemistry (glucose, blood urea nitrogen (BUN), creatinine, electrolytes), liver function tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (GGTP), total protein, bilirubin)
• Use of anti-platelet agents or other anti-coagulants

Egyéb

• Severe dyskinesia in the "OFF" or "ON" states (violent dyskinesias, incompatible with any normal motor task)
• Severe obesity
• Patients that cannot undergo MRI or PET scanning (i.e. patients with implanted pacemakers)
• Patients unable to travel to the PET scanning center

• Signed informed consent form (ICF) indicating the patient has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
• Patient diagnosed with idiopathic PD of ≤ 13 years duration, as defined by the United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria
• Outpatients (male and female) 30 - 70 years old. Females must be of non-child bearing potential, or with a negative pregnancy test and not breast-feeding
• Patients receiving a stable dose of levodopa for at least 3 months with the expectation that the treatment will remain unchanged throughout the course of the patient's participation in the trial
• Patients receiving an anti-parkinsonian treatment at a stable dose for at least 3 months with the expectation that the treatment will remain unchanged throughout the course of the patient's participation in the trial
• Hoehn and Yahr stage II-IV during "ON" time
• Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) in the "OFF" state ≤ 49
• Positive dopaminergic response of ≥ 33% decrease in UPDRS motor scores between "OFF" and "ON" states at screening, and unequivocal clinical off periods
• Patient is experiencing motor fluctuations with at least two cumulative hours of daily "OFF" -time during the waking period, which is measured on at least two consecutive days
• History of anti-parkinsonian treatment with sufficient doses of levodopa
• Stable, well-controlled concomitant disorders that would not contraindicate general anesthesia or stereotactic neurosurgery
• No abnormalities on baseline brain MRI
• Insufficient control of PD symptoms or intolerable side effects with optimized oral PD therapy
• Montreal Cognitive Assessment (MOCA) score ≥ 26
• Willing to fully comply with all study procedures and requirements of the trial
• No surgery for PD or been treated with neuroleptics in the past 6 months except low-dose quetiapine fumarate or clozapine
• No significant further improvement with physical therapy/rehabilitation