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Clinical Trials in the USA / NCT06344026
Enrolling by invitation Phase 1

Phase 1/2a Study of ANPD001 in Parkinson Disease

NCT06344026 · tracked via the Priya Life Science USA tracker
Sponsor
Aspen Neuroscience
Phase
Phase 1
Started
2024-01-23
Last updated
2026-05-14

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

ANPD001Custom Device

ANPD001: 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.

Custom Device: A custom device to facilitate slow injection of small volumes of investigational drugs (including cell therapies), under MRI guidance

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
University of Arizona - Banner Health Tucson Arizona
Scripps Health La Jolla California
University of California, Los Angeles Los Angeles California
University of California, Irvine Orange California
University of California, San Diego San Diego California
University of California, San Francisco San Francisco California
University of Colorado Aurora Colorado
Emory University Atlanta Georgia
Feinstein Institutes Manhasset New York

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06344026 on ClinicalTrials.gov ↗ ← All trials in the USA