Principal Investigator Agnete Kirkeby from the Novo Nordisk Foundation for Stem Cell Medicine has together with a team from Lund Stem Cell Center in Sweden developed a stem cell therapy which is now going into clinical trial in Sweden. The hope is with one injection to cure patients with Parkinson’s.
“This achievement is built on work which was started back in 2009 when I started as a postdoc in Malin Parmar’s lab in Lund. After gaining the first positive results from cell transplantations in animal models of Parkinson’s Disease in 2012, we‘ve worked very hard towards making a stem cell therapy to the quality, purity and safety levels suitable for transplantation in humans. Now, we’ve been granted approval from the Swedish authorities to enter clinical trial with this product, which hopefully means that we will soon be transplanting the first patients. It’s very emotional for me to see this project having reached so far”; says Agnete Kirkeby, who is a Principal Investigator at reNEW UCPH and who leads the preclinical development of the stem cell product at Lund University.
The decision from the Swedish Medical Products Agency (MPA) provides regulatory approval for a Phase I/IIa clinical trial for STEM-PD; a human embryonic stem cell based medicinal product for the treatment of Parkinson’s Disease. STEM-PD is a stem cell derived dopamine nerve cell product designed to replace the dopamine cells which are lost in the brains of Parkinson’s disease patients. Ethical approval of the trial has already been obtained from the Swedish Ethics Review Authority, and the STEM-PD team, led by Malin Parmar at Lund University in Sweden, is thereby ready to proceed with the trial.
“Getting stem cell therapies into clinical trial is an enormous task which has been undertaken through an amazing collaboration between our teams in Lund and Cambridge and supported by our close partnership with Novo Nordisk. This is the first pluripotent stem cell therapy for a CNS indication to go into clinical trial in Europe and the first pluripotent-based cell product to be administered to patients in Scandinavia. Our data shows that the STEM-PD product is safe and highly efficacious in reverting motor deficits in preclinical models of Parkinson’s Disease. We hope that cell-based therapies such as STEM-PD can provide patients with novel restorative treatment options to yield better and more long-term symptomatic relief and to minimize their dependency of daily medication”, says Agnete Kirkeby.
In a recent interview with the sciencenews.dk Agnete Kirkeby is telling about the hopefully successful therapy.