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Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease

UCI Specialty Area: Neurology
Principal Investigator: Nicolas Phielipp
Official Title: Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease
A Study On:
Parkinson Disease

Study Description

Participants will undergo a surgical implantation of cells that will mature into dopamine-producing neurons under general anesthesia into a part of the brain where dopamine production is decreased in patients with Parkinson Disease. The effect on Parkinson Disease symptoms, safety and tolerability, and cell survival are assessed for 5 years post-transplant (with MRI and PET imaging scans of the brain). Safety and tolerability are assessed annually for an additional 10 years via telephone call (total follow-up of 15 years)

Eligibility

Age 50-70 years of age at time of consent in the trial-ready cohort study ANPD001-01

Met all eligibility requirements for inclusion in the trial-ready cohort in clinical study ANPD001-01

Diagnosed with Parkinson Disease at least 4 years ago

Unequivocal motor response to Levodopa

Prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of ANPD001

History of intracranial therapy for PD, including deep brain stimulation (DBS), focused ultrasound (FUS), gene therapy or other biological therapy

History of cognitive impairment or dementia

History of clinically significant Dopa Dysregulation syndrome

History of epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological disease (other than PD), or poorly controlled cardiovascular disease

Inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks

History of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas

Contraindication to MRI and/or use of gadolinium

Weight > 300 lbs or Body Mass Index (BMI) > 35

Uncontrolled diabetes (HbA1c > 7.0%) or any other acute or chronic medical condition that would significantly increase the risks of a neurosurgical procedure

Pregnancy or lactation

Significant drug-induced dyskinesia (>2 for any body part on the Abnormal Involuntary Movement Scale [AIMS])

Male or female with reproductive capacity who is unwilling to use barrier contraception for 3 months post-administration of the investigational product

Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments

Any significant issue raised by the neurologist or neurosurgeon

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
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    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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