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

Lund University

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.

“We are excited and looking forward to this clinical study of STEM-PD, hoping that it could potentially help reduce the significant burden of Parkinson’s disease. This has been a massive team effort for over a decade, and the regulatory approval is a major and important milestone” says Professor Malin Parmar who leads the STEM-PD team from Lund University in close collaboration with her colleagues at Skåne University Hospital, the University of Cambridge, Cambridge University Hospitals NHS Foundation Trust (CUH), and Imperial College London.

STEM-PD is an investigational human embryonic stem cell based dopamine nerve cell product designed to replace the cells which are lost in Parkinson’s disease. This is the first such trial in Europe and the preclinical and clinical studies of STEM-PD have been funded by national and EU funding agencies. In addition, the STEM-PD team has obtained funding and valuable support for the current study from Novo Nordisk; a collaboration which will continue for future product development.

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 from Lund University, who has led the preclinical development of the product.

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 STEM-PD trial plans to enroll a total of 8 patients for transplantation, starting with patients from Sweden, and with subsequent plans for enrolment of patients also from Cambridge University Hospital in the UK. Trial initiation is pending clinical site inspection from the authorities. It is not possible to volunteer to participate in the trial.

Skåne University Hospital in Lund (Sweden) is the clinical sponsor of the trial and the site where all transplantation surgery will be performed. STEM-PD builds on a long history of similar work at this site: “Our teams have previously performed cell transplantation trials in Parkinson’s disease, but this is the first trial using a stem cell derived medicinal product for replacement of dopamine neurons.” says Håkan Widner, sponsor representative from Skåne University Hospital. Professor Roger Barker from the University of Cambridge and CUH, the clinical lead on the project also comments that “The use of stem cells will in theory enable us to make unlimited amounts of dopamine neurons and thus opens the prospect of producing this therapy to a wide patient population. This could transform the way we treat Parkinson’s disease”.

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