NCT06344026Enrolling by invitationPhase 1
Phase 1/2a Study of ANPD001 in Parkinson Disease
Phase 1/2a Dose Escalation Study of ANPD001 in Sporadic Parkinson Disease
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 23 Jan 2024
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Aspen Neuroscience
- Diseases
- Parkinson disease
- NCT number
- NCT06344026
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From 23 Jan 2024 to the primary completion date, 30 Mar 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior brain surgery that, in the opinion of the neurologist or neurosurgeon, contraindicates administration of ANPD001
- Inability to temporarily stop anticoagulation or antiplatelet therapy for at least 2 weeks
- 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
Other illness
- 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
- History of malignancy (cerebral or systemic) within the prior 5 years, except treated cutaneous squamous or basal cell carcinomas
Lab values
- 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
Other
- Contraindication to MRI / contrast CRT and/or use of contrast agents
- Weight \> 300 lbs or Body Mass Index (BMI) \> 35
- Pregnancy or lactation
- Unable to comply with the protocol procedures, including frequent and prolonged follow-up assessments
- Any significant issue raised by the neurologist or neurosurgeon
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Scripps Health Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Feinstein Institutes Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Arizona - Banner Health Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.