Clinical Trial Title
A Phase 2, Randomized, Double-Blind, Sham Surgery-Controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults with Moderate Stage Parkinson’s Disease (Prot. No. ASK-PD5-CS201 / Regenerate-PD)National Clinical Trial Number:
NCT06285643Contact Information
Clinical Trial Protocol Description:
Asklepios is conducting a research study at Rush University Medical Center designed to evaluate the efficacy and safety of surgically implanted gene therapy to the brain in subjects with Parkinson’s disease (PD) as a potential disease modifying therapy.
Participation in this study may last up to 4 years, and you will be asked to complete up to 20 study visits. Some of these visits will be conducted remotely by video/phone calls. A one-time surgical procedure (gene transfer or control (no injection)) will occur at a study specific Neurosurgical site (not Rush) and will include a stay in the hospital (not Rush) for approximately 1 to 3 days. The gene transfer is a brain surgery procedure that would inject gene transfer particles containing the GDNF gene directly into your brain.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a man or woman between 45 and 75 years of age.
- Speak English.
- Have been diagnosed with idiopathic PD in the past 4-10 years.
- Have motor fluctuations.
- Are taking minimum of 300mg/day of levodopa and have no prior use of intestinal gel, subcutaneous levodopa or apomorphine pump.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Contact Information
(312) 563-2900 (mention REGENERATE-PD study)
laura_montoyaquinchia@rush.edu