A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Kenai Therapeutics
Study ID
NCT07106021
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Parkinson´s Disease
  • Parkinson's Disease

Eligibility Criteria

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

Interventions

  • RNDP-001 — BIOLOGICAL
    Stem cells
  • Syringe Front-Loading Device — DEVICE
    Delivers the stem cells

Study Details

This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.

Key Dates

Start date
Jul 17, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2031

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: First patient group
    Low dose
  • Experimental: Second patient group
    High dose
  • Experimental: Third patient group
    Best dose

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Baseline to 15 months post-transplant ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85721
Marisa Valletta
[email protected]
1 (520) 626-7322
Keck Medical Center of University of Southern CaliforniaLos AngelesCalifornia90033-
The Ohio State University Wexner Medical CenterColumbusOhio43210
[email protected]
1 (614) 366-1648

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZKeck Medical Center of University of Southern California· Los Angeles, CAThe Ohio State University Wexner Medical Center· Columbus, OH

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