Cellular Intelligence acquires global rights to STEM-PD program

Cellular Intelligence has acquired global rights from Novo Nordisk to STEM-PD, an allogeneic, or donor-derived, stem cell therapy program for Parkinson’s disease.

Under the terms of the agreement, Cellular Intelligence will apply its artificial intelligence (AI) platform to advance the clinical development and manufacturing of the cell therapy, while Novo Nordisk becomes an equity investor in Cellular Intelligence and is eligible to receive future milestones and royalties.

The therapy is currently being evaluated for safety, tolerability, and feasibility in a first-in-human Phase 1/2 trial, STEM-PD (NCT05635409), which enrolled eight participants at two clinical sites in the U.K. and Sweden.

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“This cell therapy Parkinson’s program is truly innovative and exemplifies the powerful convergence of exciting academic discovery with the uncompromising quality of a global pharmaceutical leader, and we are honored to carry the program into its next chapter,” Micha Breakstone, PhD, co-founder and CEO of Cellular Intelligence, said in a company press release.

“Optimizing and scaling complex cell therapy programs to reach patients globally is exactly the challenge our AI-native platform was built to solve,” Breakstone added.

Parkinson’s is caused by the progressive loss of dopaminergic neurons — the nerve cells that produce dopamine, a signaling molecule involved in motor control. These neurons are primarily found in the substantia nigra, a brain region that sends signals to the striatum to help control movement. By the time of clinical diagnosis, patients have typically lost many of these neurons.

Currently available therapies for Parkinson’s focus mainly on restoring dopamine signaling in the brain, helping to ease disease symptoms. However, they do not restore lost neurons or slow disease progression. Cell therapies are being developed as a potential way to replace lost dopaminergic neurons, addressing a core feature of the disease.

The STEM-PD program started as a research collaboration between the University of Cambridge in the U.K. and Lund University in Sweden. The process involves creating dopamine progenitor cells from human embryonic stem cells in the lab and transplanting them into the striatum of people with Parkinson’s, where they are expected to mature into dopamine-producing neurons.

Published preclinical data showed no adverse effects or tumor formation in rats up to nine months after transplantation. In a rat model of Parkinson’s, STEM-PD cells survived transplantation and matured into dopaminergic neurons, connected with the correct brain regions and reversed the rats’ motor deficits.

These results supported the STEM-PD trial. The trial was designed to assess the safety, tolerability, and feasibility of a single dose of STEM-PD in the year after transplant in adults with moderate Parkinson’s disease, ages 50-75, who have been living with the disease for more than 10 years and whose symptoms are not well controlled with available oral therapies.

Early trial tested safety of STEM-PD

Following positive safety data on the first four dosed patients, the study moved to a higher-dose group of four additional patients. The trial is also assessing the survival of transplanted cells and potential clinical benefits for up to three years.

The agreement with Cellular Intelligence is intended to accelerate the therapy’s development timelines, reduce costs, and scale cell therapy production. To advance this program, the company appointed Nuno Mendonça, MD, a board-certified neurologist, as chief medical officer.

“Finding the right steward for the program was critical, and we are convinced that Cellular Intelligence has the capabilities needed to advance it further,” said Jacob Petersen, Novo Nordisk’s senior vice president of global research. “The convergence of developmental biology and genomics, and the possibility of combining this with AI on a single platform, provide an exciting opportunity in medicine in general, and for the cell therapy field in particular.”

STEM-PD has received Fast Track designation from the U.S. Food and Drug Administration (FDA), which aims to accelerate the development and review of therapies for serious conditions with unmet medical needs. The FDA has also cleared the program to move into Phase 2 clinical development.