Parkinsonian Brain Repair Using Human Stem Cells

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT02780895
• Date of registration: 12/05/2016
• Prospective Registration: No
• Primary sponsor: Celavie Bioscences, LLC
• Public title: Parkinsonian Brain Repair Using Human Stem Cells HSCfPD
• Scientific title: Human OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's Disease
• Date of first enrolment: May 2014
• Target sample size: 8
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02780895
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Mexico

Contacts

• Name: Oleg Kopyov, MD, PhD
• Affiliation: Celavie Bioscences, LLC

• Name: Ignacio Madrazo, MD, PhD
• Affiliation: Hospital Angeles del Pedregal

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson Disease

Intervention(s)

Drug: Human Stem Cells

Primary Outcome(s)

Safety as Measured by the Number and Severity of Adverse Events [Time Frame: three years]

Secondary Outcome(s)

Beck Anxiety Inventory (BAI) [Time Frame: three years]

Minnesota Multiphasic Personality Inventory (MMPI) [Time Frame: three years]

Sensory-Perceptual Examination [Time Frame: three years]

Trailmaking Test (TMT) [Time Frame: three years]

Benton Facial Recognition Test [Time Frame: three years]

Benton Judgment of Line Orientation (JLO) [Time Frame: three years]

Brief Test of Attention (BTA) [Time Frame: three years]

Coping Responses Inventory (CRI) [Time Frame: three years]

DTBZ ([18F]9-fluoropropyl-(+)-dihydrotetrabenazine) uptake [Time Frame: three years]

Hand Dynamometer [Time Frame: three years]

Controlled Oral Word Association Test (COWAT) [Time Frame: three years]

Delis-Kaplan Executive Function Scale (DKEFS) [Time Frame: three years]

California Verbal Learning Test (CVLT) [Time Frame: three years]

Cognitive Estimation Test (CET) [Time Frame: three years]

Finger Tapping [Time Frame: three years]

Halstead Category Test [Time Frame: three years]

FDOPA (L-3,4-dihydroxy-6-(18)F-fluorophenylalanine) uptake [Time Frame: three years]

Intelligence Kaufman Brief Intelligence Test (KBIT) [Time Frame: three years]

Hooper Visual Organization Test (VOT) [Time Frame: three years]

Stroop Test [Time Frame: three years]

Raclopride uptake [Time Frame: three years]

Rey Complex Figure Test (RCFT) [Time Frame: three years]

Complex Ideational Material [Time Frame: three years]

Efficacy as measured by the Unified Parkinson Disease Rating Scale (UPDRS) [Time Frame: three years]

Life Stressors and Social Resources Inventory (LISRES) [Time Frame: three years]

Mattis Dementia Rating Scale (DRS) [Time Frame: three years]

Auditory Consonant Trigrams (ACT) [Time Frame: three years]

Beck Depression Inventory (BDI) [Time Frame: three years]

Barona Demographic Equation [Time Frame: three years]

Benton Visual Retention Test (BVRT-R) [Time Frame: three years]

Grooved Pegboard [Time Frame: three years]

Hamilton Depression Scale (HDS) [Time Frame: three years]

Continuous Performance Tests (CPT) [Time Frame: three years]

Paced Auditory Serial Addition Test (PASAT) [Time Frame: three years]

State-Trait Anxiety Inventory (STAI) [Time Frame: three years]

Wechsler Adult Intelligence Scale (WAIS) [Time Frame: three years]

North American Adult Reading Test (NAART) [Time Frame: three years]

Parkinson's Disease Questionnaire (PDQ) [Time Frame: three years]

Raven's Progressive Matrices [Time Frame: three years]

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time Frame: three years]

Ways of Coping Questionnaire [Time Frame: three years]

Wechsler Abbreviated Scale of Intelligence (WASI) [Time Frame: three years]

Rey Auditory Verbal Learning Test (RAVLT) [Time Frame: three years]

Token Test [Time Frame: three years]

Wide Range AchievementTest (WRAT) [Time Frame: three years]

Wisconsin Card Sorting Test (WCST) [Time Frame: three years]

Wechsler Memory Scale (WMS) [Time Frame: three years]

Boston Naming Test (BNT) [Time Frame: three years]

Digit and Visual Spans [Time Frame: three years]

Pro?le of Mood States (POMS) [Time Frame: three years]

Sentence Repetition [Time Frame: three years]

Wechsler Test of Adult Reading (WTAR) [Time Frame: three years]

Secondary ID(s)

CMN2012-027

OK99-2014-2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital Angeles del Pedregal