Idiopathic Parkinson Disease Clinical Trial
— HSCfPDOfficial title:
Human OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's Disease
Implantation of Celavie human stem cells (OK99) is intended to address the underlying pathology of the disease by replacing damaged/destroyed cells of the brain, and/or stimulating the patient's brain to repair itself.
Status | Active, not recruiting |
Enrollment | 8 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of idiopathic PD with tremor, rigidity or hypokinesia as major symptoms. - A two to twenty-five-year history of PD with significant medical management or difficulty in medical management. - A definite response to levodopa compounds with inadequately relieved of symptoms, or severe secondary effects of the drug. - Good general health. - A strong will or desire to have the procedure after being fully informed of its experimental nature. Exclusion Criteria: - History of repeated strokes with stepwise progression of parkinsonian features - History of repeated head injury - History of definite encephalitis - Oculogyric crises (unless drug-induced) - Neuroleptic treatment at onset of symptoms - Supranuclear gaze palsy - Cerebellar signs - Babinski sign - Presence of cerebral tumor or communicating hydrocephalus on CT scan - Sustained remission or negative response to an adequate dose of levodopa - Patients with parkinsonism other than Idiopathic PD |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Angeles del Pedregal | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Celavie Bioscences, LLC | Hospital Angeles del Pedregal |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as Measured by the Number and Severity of Adverse Events | three years | Yes | |
Secondary | FDOPA (L-3,4-dihydroxy-6-(18)F-fluorophenylalanine) uptake | Positron Emission Tomography | three years | Yes |
Secondary | Raclopride uptake | Positron Emission Tomography | three years | Yes |
Secondary | DTBZ ([18F]9-fluoropropyl-(+)-dihydrotetrabenazine) uptake | Positron Emission Tomography | three years | Yes |
Secondary | Barona Demographic Equation | Premorbid Estimates | three years | Yes |
Secondary | North American Adult Reading Test (NAART) | Premorbid Estimates | three years | Yes |
Secondary | Wechsler Test of Adult Reading (WTAR) | Premorbid Estimates | three years | Yes |
Secondary | Wide Range AchievementTest (WRAT) | Premorbid Estimates | three years | Yes |
Secondary | Mattis Dementia Rating Scale (DRS) | Neuropsychological Screening | three years | Yes |
Secondary | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Neuropsychological Screening | three years | Yes |
Secondary | Intelligence Kaufman Brief Intelligence Test (KBIT) | Neuropsychological Screening | three years | Yes |
Secondary | Raven's Progressive Matrices | Neuropsychological Screening | three years | Yes |
Secondary | Wechsler Abbreviated Scale of Intelligence (WASI) | Neuropsychological Screening | three years | Yes |
Secondary | Wechsler Adult Intelligence Scale (WAIS) | Neuropsychological Screening | three years | Yes |
Secondary | Auditory Consonant Trigrams (ACT) | Attention and Working Memory | three years | Yes |
Secondary | Brief Test of Attention (BTA) | Attention and Working Memory | three years | Yes |
Secondary | Continuous Performance Tests (CPT) | Attention and Working Memory | three years | Yes |
Secondary | Digit and Visual Spans | Attention and Working Memory | three years | Yes |
Secondary | Paced Auditory Serial Addition Test (PASAT) | Attention and Working Memory | three years | Yes |
Secondary | Stroop Test | Attention and Working Memory | three years | Yes |
Secondary | Cognitive Estimation Test (CET) | Executive Function | three years | Yes |
Secondary | Delis-Kaplan Executive Function Scale (DKEFS) | Executive Function | three years | Yes |
Secondary | Halstead Category Test | Executive Function | three years | Yes |
Secondary | Trailmaking Test (TMT) | Executive Function | three years | Yes |
Secondary | Wisconsin Card Sorting Test (WCST) | Executive Function | three years | Yes |
Secondary | Benton Visual Retention Test (BVRT-R) | three years | Yes | |
Secondary | California Verbal Learning Test (CVLT) | Memory | three years | Yes |
Secondary | Rey Auditory Verbal Learning Test (RAVLT) | Memory | three years | Yes |
Secondary | Rey Complex Figure Test (RCFT) | Memory | three years | Yes |
Secondary | Wechsler Memory Scale (WMS) | Memory | three years | Yes |
Secondary | Boston Naming Test (BNT) | Language | three years | Yes |
Secondary | Controlled Oral Word Association Test (COWAT) | Language | three years | Yes |
Secondary | Sentence Repetition | Language | three years | Yes |
Secondary | Token Test | Language | three years | Yes |
Secondary | Complex Ideational Material | Language | three years | Yes |
Secondary | Benton Facial Recognition Test | Visuoperception | three years | Yes |
Secondary | Benton Judgment of Line Orientation (JLO) | Visuoperception | three years | Yes |
Secondary | Hooper Visual Organization Test (VOT) | Visuoperception | three years | Yes |
Secondary | Finger Tapping | Motor and Sensory Perception | three years | Yes |
Secondary | Grooved Pegboard | Motor and Sensory Perception | three years | Yes |
Secondary | Hand Dynamometer | Motor and Sensory Perception | three years | Yes |
Secondary | Sensory-Perceptual Examination | Motor and Sensory Perception | three years | Yes |
Secondary | Beck Anxiety Inventory (BAI) | Mood State and Personality | three years | Yes |
Secondary | Beck Depression Inventory (BDI) | Mood State and Personality | three years | Yes |
Secondary | Hamilton Depression Scale (HDS) | Mood State and Personality | three years | Yes |
Secondary | Minnesota Multiphasic Personality Inventory (MMPI) | Mood State and Personality | three years | Yes |
Secondary | Pro?le of Mood States (POMS) | Mood State and Personality | three years | Yes |
Secondary | State-Trait Anxiety Inventory (STAI) | Mood State and Personality | three years | Yes |
Secondary | Parkinson's Disease Questionnaire (PDQ) | Quality of Life, Coping, and Stressors | three years | Yes |
Secondary | Coping Responses Inventory (CRI) | Quality of Life, Coping, and Stressors | three years | Yes |
Secondary | Ways of Coping Questionnaire | Quality of Life, Coping, and Stressors | three years | Yes |
Secondary | Life Stressors and Social Resources Inventory (LISRES) | Quality of Life, Coping, and Stressors | three years | Yes |
Secondary | Efficacy as measured by the Unified Parkinson Disease Rating Scale (UPDRS) | three years | Yes |
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