ANPD001 for Parkinson's Disease (ASPIRO Trial)

Phase 1

Waitlist Available

Research Sponsored by Aspen Neuroscience

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year (primary follow up) and 5 years (long term follow up)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety of injecting special cells into the brains of people with Parkinson's disease. These cells will eventually produce dopamine, a chemical lacking in Parkinson's patients. The cells will be made

Who is the study for?

This trial is for individuals with Parkinson's Disease who are willing to have cells, previously collected from their own bodies, modified and injected back into their brain. The details of the eligibility criteria were not provided.

What is being tested?

The study is testing ANPD001, a treatment involving cells that mature into dopamine-producing neurons in the brain. Participants will receive these specialized cells derived from their own tissues.

What are the potential side effects?

Specific side effects are not listed, but since this involves brain injections and cell therapy, potential risks may include infection, immune reaction, or neurological changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year (primary follow up) and 5 years (long term follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year (primary follow up) and 5 years (long term follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (primary follow up) and 5 years (long term follow up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV)

Post-injection change in the 18F-DOPA uptake in the putamen

Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state