Higher dose cohort initiated after positive early safety evaluation in Parkinson's therapy.
After a positive initial safety evaluation, the pioneering STEM-PD clinical trial has advanced to higher dose testing.
STEM-PD is a first-in-human clinical trial testing a new investigational therapy for Parkinson's disease aimed at replacing the dopamine cells lost to the disease with healthy ones derived from stem cells.
The first patient in the the trial was transplanted at Skåne University Hopsital, Lund, Sweden, in February 2023, and the STEM-PD team now announces to have completed dosing of the first four patients with the initial lower dose of cells (3.5 million cells per putamen/7 million in total).
Based on the safety data, the study team has now proceeded as planned and initiated dosing of the next four patients with a higher dose of cells (7 million cells per putamen/14 million in total). The first patient in the higher dose cohort have now been transplanted and the remaining 3 patients will be grafted during 2024 and followed for 36 months within this trial.
The primary objective of the trial is to assess the safety and tolerability of the stem cell product STEM-PD over one year post grafting. No concerning side effects from the intervention have been reported and the patients are all doing well.
Secondary objectives of the trial include assessment of transplanted cell survival through dopamine PET imaging as well as evaluation of clinical efficacy three years post transplantation. It is still too early to evaluate clinical effects of the transplanted cells, but PET imaging of patient brains at 6-12 months post transplantation shows signs of dopamine cell survival.
The trial was approved by the Swedish Medical Products Agency in October 2022 and by the UK Medicines & Healthcare products Regulatory Agency in October 2023, enabling inclusion of UK patients in cohort number two.
- Press release from February 28, 2023: First patient receives milestone stem cell-based transplant for Parkinson's Disease
