Actively Recruiting
A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
Led by Kenai Therapeutics · Updated on 2026-01-23
12
Participants Needed
3
Research Sites
195 weeks
Total Duration
On this page
Sponsors
K
Kenai Therapeutics
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of an investigational treatment called RNDP-001, which involves implanting dopaminergic stem cells directly into the brain of patients with idiopathic Parkinson's disease. This early-phase clinical trial aims to assess how well participants tolerate the stem cell transplant and monitor any related effects. The study is sponsored by Kenai Therapeutics and involves patients aged 45 to 75 who are medically stable for surgery. Participants receive RNDP-001 stem cells delivered into the brain using a specialized syringe front-loading device during a surgical procedure. The trial includes three groups receiving low, high, or best doses of the stem cells to evaluate different levels of treatment. This procedure is non-randomized and unblinded, meaning all participants receive the study intervention, and dosing groups are assigned without random allocation. Throughout the study, participants will be closely monitored from baseline up to 15 months after the transplant. Researchers will assess safety and tolerability, track changes in quality ON time using Parkinson's disease diaries, and evaluate dopaminergic function and brain activity. Various medical assessments, imaging, and clinical evaluations will be conducted to understand the treatment impact and participant health over time.
CONDITIONS
Brief Title
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
- Age 45 to 75 years
- Medically stable to undergo a surgical procedure
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo surgical implantation of stem cells using a device and receive immediate post-operative care.
1 surgical visit and several immediate post-operative visits
Duration - Up to 15 months post-transplant
Participants are monitored for safety, tolerability, and changes in symptoms after surgery.
Regular follow-up visits over 15 months
Trial Site Locations
Total: 3 locations
1
University of Arizona
Tucson, Arizona, United States, 85721
Actively Recruiting
2
Keck Medical Center of University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
G
General Inquiries
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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