STEM-PD Shows 12-Month Safety in 8-Patient Parkinson's Trial as PET Signals Graft Survival
Updated
Updated · BIOENGINEER.ORG · Jul 9
STEM-PD Shows 12-Month Safety in 8-Patient Parkinson's Trial as PET Signals Graft Survival
3 articles · Updated · BIOENGINEER.ORG · Jul 9
Summary
Seven of eight Parkinson’s patients reached 12 months after bilateral STEM-PD transplants, with no serious adverse events tied to the cell product, no tumor formation on MRI and no graft-induced dyskinesias.
One participant died 10 weeks after surgery from a fungal pulmonary infection linked to the immunosuppression regimen, underscoring that the main safety risk came from adjunctive anti-rejection treatment rather than the cells or device.
PET scans showed focal increases in F-DOPA uptake in grafted putamen regions—stronger in the high-dose cohort, where putamen-to-caudate ratios rose 11.5% to 14.9%, versus 3.2% to 5.7% in the low-dose group.
Clinical signals were mixed but encouraging: six of seven surviving patients cut Parkinson’s medication, with levodopa-equivalent doses down 15.6% in the low-dose group and 27.5% in the high-dose group after 12 months.
The open-label phase 1/2 study remains small and early-stage, and investigators will follow patients to 36 months to test durability, graft function and whether benefits outweigh immunosuppression risks.
With Japan approving a rival therapy, are embryonic stem cells already obsolete for treating Parkinson's disease?
This new therapy requires brain surgery and intense immune suppression. Is the cure more dangerous than the disease?
Can healthcare systems afford this revolutionary Parkinson's treatment for the millions who will need it?
Landmark 12-Month Safety Results from the STEM-PD Trial: A New Era for Stem Cell Therapy in Parkinson’s Disease
Overview
The STEM-PD trial has reached a major milestone by completing its 12-month follow-up, showing encouraging results for stem cell-derived dopaminergic cell transplantation in Parkinson's disease. This pioneering study delivered dopamine cell therapies to patients, building on decades of research into brain repair. The trial focused on evaluating the safety, tolerability, and feasibility of transplanting a cryopreserved dopaminergic progenitor cell product derived from the human ES cell line RC17. Its successful execution was made possible by the combined expertise of scientists and clinicians from Lund and Cambridge, marking an exciting new direction for Parkinson's disease treatment.