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Nature Medicine lists: clinical trials that will shape medicine 2024

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Nature Medicine asked leading researchers which clinical trials in the coming year that are likely to have an outsized impact on medicine. One of the 11 listed trials were the trial "Stem cells for Parkinson’s disease" done at Region Skåne in Lund. Both, WCMM Fellow Agnete Kirkeby and WCMM researcher Gesine Paul Visse, are part of the responsible team.

The STEM-PD trial will transplant dopaminergic neurons derived from human embryonic stem cells into the brains of patients 50–75 years of age with moderate Parkinson’s disease. It is important both because it is one of the few trials testing a human embryonic stem cell therapy in Parkinson’s disease, and because we are targeting people with moderate disease, which gives them the most chance to benefit from the therapy. The first patients were administered doses in February 2023, and we hope to have preliminary results by the end of 2024. 

The trial will investigate the safety and tolerability of transplanting STEM-PD cells into the brain of patients with moderate Parkinson’s disease and the primary outcome is safety and tolerability at 1-year post-transplantation. Secondary endpoints will be survival and function of the transplanted cells by brain imaging as well as effects on Parkinson’s symptoms.

The STEM-PD team is lead by Prof. Malin Parmar, Lund University, in close collaboration with WCMM Fellow Agnete Kirkeby and colleagues at Skåne University Hospital for example WCMM researcher Gesine Paul Visse, responsible clinician SUS-Lund, the University of Cambridge, Cambridge University Hospitals NHS Foundation Trust (CUH), and the Imperial College London.

What is STEM-PD?

STEM-PD is a clinical trial run by clinical and preclinical research teams in Sweden and the UK. The goal of the trial is to develop a safe and efficacious stem cell-based treatment for Parkinson’s disease.

The trial involves transplantation of stem cell-derived dopamine STEM-PD cells into the brains of Parkinson’s disease patients. The stem cell product to be transplanted in this trial is named “STEM-PD”. The cells are designed to form new functional dopamine neurons in the brain of the patient after transplantation, with the aim of replacing those neurons which have been lost during the course of the disease.

This clinical trial is an investigator-lead clinical trial sponsored by Skåne University Hospital in Lund and registered as EudraCT 2021-001366-38. The development of the product and the clinical trial has been funded by national and EU funding agencies as well as by the pharmaceutical company Novo Nordisk.

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Gesine Paul-Visse. Portrait.

Gesine Paul-Visse

Principal Investigator

Phone: +46 17 77 66

Email: gesine [dot] paul-visse [at] med [dot] lu [dot] se

Profile in Lund University Research Portal

Agnete Kirkeby. Portrait.

Agnete Kirkeby

Principal Investigator

Phone: +45 51 68 53 53

Email: agnete [dot] kirkeby [at] med [dot] lu [dot] se

Profile in Lund University Research Portal