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Phase 1/2a Study of ANPD001 in Parkinson Disease

Enrolling By InvitationPhase 1

Sponsor: Aspen Neuroscience

Conditions: Parkinson Disease

Interventions: ANPD001, Custom Device

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 40-75 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 / contrast CRT and/or use of contrast agents
* Weight \> 300 lbs or Body Mass Index (BMI) \> 35
* Newly diagnosed diabetes (HbA1c \> 7.0%), uncontrolled diabetes \> 8.0% requiring frequent medication changes, 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 (\> 3 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

Locations (9)

Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Manhasset, New York, United States