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Swedish Medical Products Agency grants approval for clinical study of new stem cell based Parkinson’s Disease treatment

Dopamine-producing neurons that researchers from Lund University have grown in the laboratory from human embryonic stem cells (Photo: Agneta Kirby)
Dopamine-producing neurons that researchers from Lund University have grown in the laboratory from human embryonic stem cells (Photo: Agneta Kirkeby)

An investigational stem cell-based therapy for the treatment of Parkinson’s Disease, STEM-PD, has been given regulatory approval for a Phase I/IIa clinical trial. Ethical approval of the trial has already been obtained from the Swedish Ethics Review Authority, and the STEM-PD team, led from Lund University in Sweden, is thereby ready to proceed with the trial.

WCMM members Agnete Kirkeby and Gesine Paul-Visse are part of the team behind STEM-PD - a new kind of dopaminergic nerve cell therapy designed to replace cells lost in Parkinson's disease, the first of its kind in Europe!

The STEM-PD trial is investigating the safety and tolerability of transplanting STEM-PD cells into the brain of patients with moderate Parkinson’s disease (EudraCT Number:2021-001366-38). The primary outcome of the STEM-PD trial is to assess safety and tolerability of the transplanted product at 1-year post-transplantation, while secondary endpoints will assess survival and function of the transplanted cells by brain imaging, as well as measure effects on Parkinson’s symptoms.

The cells to be used in the trial have been manufactured under good manufacturing practice (GMP) at the Royal Free Hospital in London and have undergone rigorous testing in the lab. “Our data shows that the STEM-PD product is safe and highly efficacious in reverting motor deficits in preclinical models of Parkinson’s disease” says Agnete Kirkeby, who has led the preclinical development of the product.