Phase 1/2a Study of ANPD001 in Parkinson Disease

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Aspen Neuroscience
Study ID
NCT06344026
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ANPD001 — BIOLOGICAL
    Biologic: ANPD001 is an experimental product derived from the patient's own skin cells converted to induced pluripotent stem cells. The stem cells were differentiated into precursors for brain cells that produce dopamine.
  • Custom Device — DEVICE
    A custom device to facilitate slow injection of small volumes of investigational drugs (including cell therapies), under MRI guidance

Study Details

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 Dates

Start date
Jan 23, 2024
Status verified
May 2026
Primary completion
Mar 30, 2027
Completion
Apr 30, 2030

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ANPD001

Primary Outcome Measure

Incidence and severity of treatment emergent adverse events (Safety and Tolerability) [ Time Frame: 1 year (primary follow up) ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Arizona - Banner HealthTucsonArizona85724-
Scripps HealthLa JollaCalifornia92037-
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, IrvineOrangeCalifornia92868-
University of California, San DiegoSan DiegoCalifornia92037-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of ColoradoAuroraColorado80045-
Emory UniversityAtlantaGeorgia30322-
Feinstein InstitutesManhassetNew York11030-

Find similar trials in Tucson, AZ

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Arizona - Banner Health· Tucson, AZScripps Health· La Jolla, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California, Irvine· Orange, CAUniversity of California, San Diego· San Diego, CAUniversity of California, San Francisco· San Francisco, CA

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