Aspen Neuroscience
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.
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)
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…
Biologic: ANPD001 is an experimental product derived from the patient's own skin cells converted to induced pluripotent stem cells. The stem cells were differentiated into precursors for brain cells that produce dopamine.
A custom device to facilitate slow injection of small volumes of investigational drugs (including cell therapies), under MRI guidance