RNDP-001 Implant for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new treatment, RNDP-001, for people with Parkinson's disease. Participants will receive a brain implant to assess treatment tolerance and determine the optimal dose. The trial includes three groups, each receiving a low, high, or optimal dose. It seeks participants with idiopathic Parkinson's disease (a form with no known cause) who are medically stable for surgery. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the RNDP-001 implant is safe for Parkinson's Disease?
Research has shown that the RNDP-001 implant is being tested for safety and tolerability in people with Parkinson's disease. As the trial is in its early stages, detailed safety information is not yet available. However, researchers closely monitor treatments in early trials for side effects, ensuring that any unwanted effects are reported and managed carefully. Although RNDP-001 is not yet approved for any condition, the trial aims to ensure its safety for humans. Participants will receive varying doses of the implant to determine the optimal balance between efficacy and safety.12345
Why do researchers think this study treatment might be promising for Parkinson's Disease?
Researchers are excited about RNDP-001 for Parkinson's Disease because it introduces an innovative implant method that delivers the treatment directly to the brain. Unlike standard treatments like levodopa, which primarily aim to manage symptoms, RNDP-001 could potentially provide more targeted and sustained relief by directly interacting with brain pathways affected by Parkinson's. This direct delivery approach may also reduce systemic side effects, making it a promising advancement in treating this condition.
What evidence suggests that the RNDP-001 implant could be an effective treatment for Parkinson's Disease?
Research shows that RNDP-001 is an experimental treatment for Parkinson's Disease, utilizing a type of stem cell therapy. This treatment involves placing special cells, called induced pluripotent stem cells (iPSC), into the brain. These cells may help replace damaged ones and improve brain function. Previous studies on similar stem cell therapies have shown they might slow the disease and improve symptoms. Although the effectiveness of RNDP-001 in people is still under investigation, the science behind it is promising, and early lab results are encouraging. As research progresses, clearer results on its effectiveness for Parkinson’s patients are expected.23678
Are You a Good Fit for This Trial?
This trial is for individuals with idiopathic Parkinson's Disease who are eligible for a surgical procedure to implant RNDP-001, a new potential treatment. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Participants undergo surgical implantation of RNDP-001 into the brain
Post-Transplant Monitoring
Participants are monitored for safety and tolerability, including incidence of adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RNDP-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kenai Therapeutics
Lead Sponsor