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Stem Cell Therapy

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 14 years of long term follow up (4 years in-person visits and 10 additional years follow up via telephone call)
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~14 years of long term follow up (4 years in-person visits and 10 additional years follow up via telephone call)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 years of long term follow up (4 years in-person visits and 10 additional years follow up via telephone call) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of treatment emergent adverse events (Safety and Tolerability)
Secondary outcome measures
"ON" time without troublesome dyskinesia
Incidence and severity of treatment emergent adverse events during long term follow-up (Continued Safety and Tolerability)
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)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ANPD001Experimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

Aspen NeuroscienceLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
65 Previous Clinical Trials
3,166 Total Patients Enrolled
Edward D Wirth III, MD, PhDStudy ChairAspen Neuroscience
1 Previous Clinical Trials
25 Total Patients Enrolled
~6 spots leftby Oct 2025
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