Phase 1/2a Study of ANPD001 in Parkinson Disease (NCT06344026) | Clinical Trial Compass
By InvitationPhase 1
Phase 1/2a Study of ANPD001 in Parkinson Disease
United States9 participantsStarted 2024-01-23
Plain-language 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.
Who can participate
Age range50 Years – 70 Years
SexALL
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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…
What they're measuring
1
Incidence and severity of treatment emergent adverse events (Safety and Tolerability)