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A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

NCT06944522 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-01

No results posted yet for this 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

  • Parkinsons Disease (PD)

Interventions

BIOLOGICAL

bemdaneprocel

Investigational cell therapy comprising midbrain dopaminergic neuron progenitors derived from human embryonic stem cells

PROCEDURE

Sham surgery

Sham surgery will be performed on Day 0

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • BlueRock Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2027-03-31
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944522 on ClinicalTrials.gov