Phase 1/2a Study of ANPD001 in Parkinson Disease
Enrolling by invitation · Phase 1
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT06344026
- Run by
- Aspen Neuroscience
- People needed
- 9
- Starts
- 2024-01-23
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2026-05-14
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Arizona - Banner Health — Tucson, Arizona, United States
- Scripps Health — La Jolla, California, United States
- University of California, Los Angeles — Los Angeles, California, United States
- University of California, Irvine — Orange, California, United States
- University of California, San Diego — San Diego, California, United States
- University of California, San Francisco — San Francisco, California, United States
- University of Colorado — Aurora, Colorado, United States
- Emory University — Atlanta, Georgia, United States
- Feinstein Institutes — Manhasset, New York, United States
Full record on ClinicalTrials.gov
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