Aspen Neuroscience has reported results from a phase 1/2a study showing that its stem cell therapy, sasineprocel, improved symptoms in all eight Parkinson’s disease patients treated, with plans to begin a phase 3 trial later this year.
The therapy is autologous and involves taking skin cells from patients and converting them into stem cells. These cells are then guided to develop into neurons, which are implanted into the brain. The treatment aims to address the loss of dopaminergic neurons associated with Parkinson’s disease.
Data from the study were presented on March 18 at the AD/PD 2026 International Conference on Alzheimer’s and Parkinson’s Diseases. According to the company, patients experienced improvements in symptom control, motor function, and quality of life one year after treatment. These effects were observed in patients receiving both low and high doses of sasineprocel.
“All the patients are improving, and they’re all improving in a way that’s clinically significant,” said Aspen CEO Damien McDevitt, Ph.D. He noted that patients experienced an increase of more than two hours in daily “good on” time, defined as periods when symptoms are best controlled. He added that improvements exceeding one to one and a half hours are considered clinically significant.
Some patients were also able to reduce their use of levodopa, a dopamine replacement therapy commonly used to manage Parkinson’s symptoms. The disease is marked by the progressive loss of dopaminergic neurons, and levodopa is typically prescribed to supplement dopamine levels. A reduction in levodopa use indicates that the transplanted neurons may be producing dopamine. Brain imaging further showed that the implanted cells successfully engrafted and remained viable one year after surgery.
The company also described observations from patient follow-ups. In one case, a patient who previously had difficulty standing from a chair, opening a door, and walking down a hallway, along with having a low voice and muted facial expression, showed improvement one year after treatment, including the ability to rise from a chair and walk with a smooth gait.
Aspen’s chief medical officer, Revati Shreeniwas, M.D., said the findings support the company’s approach of reprogramming a patient’s own cells to return them to a pre-disease state. She added that early observations show a positive clinical impact from rebuilding neural networks affected by the disease.
Following these results, Aspen plans to engage with the U.S. Food and Drug Administration on the design of a phase 3 trial, which McDevitt said could begin later this year. He indicated that the agency will likely want a randomized, sham-controlled study design similar to that used by BlueRock Therapeutics for its Parkinson’s cell therapy candidate, bemdaneprocel, which is being evaluated in a phase 3 trial enrolling approximately 102 patients. McDevitt also said the company hopes it may be possible to use a natural history control arm instead. He noted that the surgical procedure involved is minimally invasive and relatively simple for neurosurgeons to perform.
If the phase 3 trial is successful and sasineprocel receives approval, McDevitt said Aspen plans to commercialize the therapy itself. The company raised $115 million in a series C funding round last November, with participation from Kite Pharma, the cell therapy unit of Gilead Sciences.
McDevitt also said the company is focused on the brain but is interested in other cell types and diseases, as well as opportunities outside the brain where replacing missing cells and achieving successful grafts may be possible.
Aspen Highlights Clinical Progress
According to Aspen, patients receiving Sasineprocel demonstrated measurable improvements in motor function and daily activity. These outcomes reinforce Aspen’s commitment to developing innovative treatments for Parkinson’s disease.
Sasineprocel’s Impact on Patients
The therapy evaluated by Aspen is designed to target underlying disease mechanisms rather than just symptoms. Aspen’s data suggests that Sasineprocel may offer sustained benefits, improving quality of life for patients.
Aspen Focus on Long-Term Outcomes
Aspen emphasized that one-year data is a critical milestone in understanding the long-term effectiveness of Sasineprocel. Continued monitoring by Aspen will help determine durability and safety over extended periods.
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