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 range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 dru…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of treatment emergent adverse events (Safety and Tolerability)

Timeframe: 1 year (primary follow up)

Trial details

NCT IDNCT06344026

SponsorAspen Neuroscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-30

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.