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A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
NCT06944522 · View on ClinicalTrials.gov ↗
Study Summary
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).
Conditions Studied
Interventions
- PROCEDURE Sham surgery
- BIOLOGICAL bemdaneprocel
Study Locations (20)
Michigan
- Michigan Clinical Research Unit - Neurology — Ann Arbor
- University of Michigan Clinical Research Unit - Neurology — Ann Arbor
- Quest Research Institute — Farmington Hills
New York
- UBMD Neurology — Buffalo
- Mount Sinai West - Neurology — New York
- New York Presbyterian/Weill Cornell Medical Center — New York
Florida
- University of Miami Health System - Neurology — Miami
- USF Parkinson's Disease and Movement Disorders Center — Tampa
Massachusetts
- Tufts Medical Center - Neurology — Boston
- Beth Israel Deaconess Medical Center — Boston
Arizona
- Banner Sun Health Research Institute — Sun City
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
California
- UCLA NeuroTranslational Research Center — Los Angeles
Colorado
- University of Colorado Hospital - Neurology Clinic — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2025-06-17 |
| Est. Completion | 2032-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06944522
The ClinicalTrials.gov registry entry for NCT06944522 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BlueRock Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 2 interventions — of which Sham surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06944522 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Michigan, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06944522 about?
NCT06944522 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease". Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).
What is the current status of trial NCT06944522?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2025-06-17. Estimated completion is 2032-03.
What conditions does trial NCT06944522 study?
This clinical trial studies the following conditions: Parkinsons Disease (PD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06944522?
The interventions under investigation include: Sham surgery (PROCEDURE), bemdaneprocel (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06944522?
This trial is sponsored by BlueRock Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06944522 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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