Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease
Nicolas Phielipp
A Study On:
Parkinson Disease
Status:
Open
Eligibility
Please note that this is an inexhaustive list. Additional criteria apply.
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
Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease
Details
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)