NCT07106021 · Kenai Therapeutics
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
What this study is about
This clinical trial is designed to test the safety and how well patients handle the treatment of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
View original scientific description
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.
Interventions
BIOLOGICAL
RNDP-001
Stem cells
DEVICE
Syringe Front-Loading Device
Delivers the stem cells
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tucson, Arizona
- Los Angeles, California
- Columbus, Ohio
Collaborators
California Institute for Regenerative Medicine (CIRM)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations