Pioneering STEM-PD clinical trial has advanced to higher dose

Principal investigator Agnete Kirkeby from the Novo Nordisk Foundation for Stem Cell Medicine, reNEW

After a positive interim safety evaluation, the pioneering STEM-PD clinical trial has advanced to higher dose testing.

Just over a year ago, the first patient received a dose of 7 million stem cell-derived dopamine nerve cells injected into the brain at Skånes universitetssjukhus (Skåne University Hospital) in Lund. This marks the first testing of a pluripotent stem cell therapy for brain disease in Europe.

Parkinson’s disease is a neurodegenerative disease characterized by the loss of normal motor control, leading to rigidity, slow movements, tremors, and difficulties walking. The disease affects approximately 1 percent of people above the age of 60, and, with an aging population, its prevalence is on the rise.

Based on these initial results, the trial team is now proceeding as planned to dose the next 4 patients in the trial with a higher dose of cells (14 million cells per patient).

Associate Professor Agnete Kirkeby, Principal Investigator at both reNEW Copenhagen at Københavns Universitet – University of Copenhagen and Lund University, who led the preclinical development of the STEM-PD product, says: ‘’This is an important milestone in the trial. In addition to the positive interim safety evaluation, we are now also seeing the first signs of surviving dopamine cell transplants in the brains of the patients by PET imaging, and we are hopeful that this signal will increase further over time.”

Hear more from the patient (in Swedish):

Reprogrammed neurons may fool you!

Associate Professor Agnete Kirkeby, from reNEW Copenhagen, has published the paper Forced LMX1A expression induces dorsal neural fates and disrupts patterning of human embryonic stem cells into ventral midbrain dopaminergic neurons, in Stem Cell Reports.