Phase 1/2a Study of ANPD001 in Parkinson Disease
About
Brief Summary
This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Join this Trial
Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but
only to people in that particular population, who are specifically invited to participate.
Study Stats
Protocol No.
23-001208
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood