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NCT Number: NCT07106021

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Idiopathic Parkinson´s Disease Parkinson's Disease

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Arizona, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
  • Age 45 to 75
  • Medically stable to undergo a surgical procedure

Exclusion criteria

  • Known Parkinson's disease gene mutation or variant
  • Previous infusion therapy or surgery for Parkinson's disease
  • History of allergic reaction or intolerance to an immunotherapeutic agent
  • Contraindication to MRI
  • Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments

Treatment and study plan

RNDP-001

Biological

Stem cells

Syringe Front-Loading Device

Device

Delivers the stem cells

Primary outcomes

  1. Safety and Tolerability

    Time frame: Baseline to 15 months post-transplant

    The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals

Secondary outcomes

  1. Changes from Baseline in Quality ON time measured by PD diary

    Time frame: Baseline to 15 months post-transplant

  2. Changes in Dopaminergic Function and Activity in the Brain

    Time frame: Baseline to 15 months post-transplant

    Changes in L-DOPA-positron emission tomography (PET)

Sponsors and collaborators

Lead sponsor

Kenai Therapeutics

Industry

Collaborators

  • California Institute for Regenerative Medicine (CIRM)

Registry information

Official study title

A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Aug 6, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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