Idiopathic Parkinson´s Disease, Parkinson's Disease
Conditions
Keywords
RNDP-001
Brief summary
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
BIOLOGICALRNDP-001
Stem cells
DEVICESyringe Front-Loading Device
Delivers the stem cells
Sponsors
Kenai Therapeutics
California Institute for Regenerative Medicine (CIRM)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Baseline to 15 months post-transplant | The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in Quality ON time measured by PD diary | Baseline to 15 months post-transplant | — |
| Changes in Dopaminergic Function and Activity in the Brain | Baseline to 15 months post-transplant | Changes in L-DOPA-positron emission tomography (PET) |
Countries
United States
Outcome results
None listed