| Field |
Value |
| NCT Number |
NCT06944522 |
| Status |
Recruiting |
| Sponsor |
BlueRock Therapeutics (Bayer) |
| Phase |
Phase 1/2 |
| Intervention |
Bemdaneprocel (BIOL) + Sham surgery |
Bemdaneprocel is a cell therapy product consisting of pluripotent stem cell-derived dopaminergic progenitors. These cells are designed to replace the lost dopamine-producing neurons in the substantia nigra of PD patients.
The therapy involves:
- Cell source: Human embryonic stem cells (hESCs) or induced pluripotent stem cells (iPSCs) differentiated into midbrain dopaminergic neurons
- Transplantation: Surgical implantation into the striatum
- Integration: Cells mature into functional dopamine-producing neurons that integrate into existing neural circuits
- Restoration: Restore dopamine signaling and improve motor function
- First-in-human study initiated by BlueRock Therapeutics
- Acquired by Bayer in 2019 for $600M
- Represents next-generation cell therapy beyond first-generation approaches like iNSC-DAP
- Allocation: Randomized (active vs sham surgery control)
- Blinding: Double-blind
- Primary Outcome: Safety and tolerability at 12 months
- Secondary Outcome: Motor function improvement (UPDRS Part III)
Bemdaneprocel represents a potentially curative approach to Parkinson's disease:
- Disease-modifying: Unlike symptomatic treatments, this aims to replace lost neurons
- Durable: Single treatment may provide long-lasting benefits
- Precision: Cell therapy targets the specific neuronal population lost in PD
- A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease - NCT06944522
- BlueRock Therapeutics Pipeline
- Cell Therapy Approaches for Parkinson's Disease - NeuroWiki