Landmark 158 · Trial in people
exPDite-2 bemdaneprocel Phase 3
The first sham-controlled test of these cells, in about 102 people. It will tell us whether they raise good on-time more than a fake operation at 78 weeks.
In short
A sham-surgery-controlled Phase 3 of lab-grown dopamine neurons in about 102 people; primary completion estimated March 2027.
- What it is
- Trial in people
- Outcome
- Result due Mar 2027
- When
- 2025–2027
- Size
- 102 people · Phase 3
- Approach
- Replace or repair what's lost
- Research lane
- Cell replacement
- Trial registry
- NCT06944522
- Last checked
- 18 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
BlueRock Therapeutics (Bayer). Registry NCT06944522.
What is being tested
Bemdaneprocel, the stem-cell-derived dopamine neuron graft in landmark 10, against sham surgery, randomised and double-blind, about 102 adults. Registry start 17 Jun 2025; other sources date the first surgery to August 2025. Recruiting.
What would count as success
Primary outcome: change from baseline to week 78 in diary "ON" time without troublesome dyskinesia (adjusted to 16 waking hours). Treated people are followed 5 years. Registry study completion estimated March 2032.
Sources
- ClinicalTrials.gov NCT06944522
- Bayer / BlueRock Phase 3 announcement
- Not yet verified: first-surgery date (Aug 2025 vs registry June 2025); March 2027 is the primary completion (final week-78 data), results may come later.
How it connects
Built on
- builds on Bemdaneprocel embryonic stem-cell dopamine neurons · 2025
Led to
None recorded.