Surgical implant of RNDP-001 for people with Parkinson's disease
A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
This trial tests whether surgically implanting RNDP-001 is safe and tolerable for people aged 45–75 with idiopathic Parkinson's disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Kenai Therapeutics Industry-sponsored |
| Locations | 3 sites (Tucson, Arizona and 2 other locations) |
| Trial ID | NCT07106021 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial implants RNDP-001 into the brain during a neurosurgical procedure to characterize safety and early signals of efficacy. Eligible participants are adults 45–75 with idiopathic Parkinson's disease who are medically stable for surgery and meet exclusion criteria such as known PD gene mutations or prior PD surgery. Primary outcomes emphasize safety and tolerability with structured post-operative monitoring, while secondary measures likely include clinical motor assessments and imaging follow-up. The study is conducted at three U.S. academic medical centers and requires in-person surgical and follow-up visits.
Who should consider this trial
Good fit: Ideal candidates are adults 45–75 with clinically diagnosed idiopathic Parkinson's disease who are medically fit for brain surgery and have not had prior Parkinson's infusion or surgical therapies.
Not a fit: People with known Parkinson's gene mutations, prior PD infusion or surgery, significant medical comorbidities, or MRI contraindications are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, RNDP-001 could become a new implantable treatment option that improves symptoms or slows disease progression for some people with Parkinson's disease.
How similar studies have performed: The RNDP-001 approach is relatively novel with limited direct human data, though other implantable therapies such as deep brain stimulation have a demonstrated history of clinical benefit in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tucson, Arizona and 2 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- Keck Medical Center of University of Southern California — Los Angeles, California, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: General Inquiries
- Email: patients@kenaitx.com
- Phone: <need to obtain>
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.