Aspen Neuroscience Nabs FDA RMAT Designation for its Parkinson’s Cell Therapy
The designation gives Aspen added FDA support as it advances sasineprocel, a personalized autologous cell therapy for Parkinson’s disease, through clinical development.
Neurology
Novo Nordisk Publishes Results from Embryonic Stem Cell-Derived Dopaminergic Cells for Parkinson’s Phase 1/2
The early trial, published in Nature, found that transplanting stem cell-derived dopaminergic progenitor cells into the brains of people with moderate Parkinson’s disease appeared feasible and showed a favorable 12-month safety profile,...
Kenai Therapeutics Completes Enrollment of Phase 1b/2a Parkinson’s iPSC Trial
The iPSC-derived neural cell therapy takes its next step in potentially restoring dopaminergic neurons lost to the condition.
Aspen Neuroscience Completes Cohort 3 and 4 Dosing in iPSC-Derived Phase 1/2a for Parkinson’s
The ASPIRO trial of sasineprocel is progressing; fifteen patients have been dosed with the commercial-ready formulation of the autologous cell therapy.
Steminent Filing for Japanese Approval of its Mesenchymal Stem Cell Therapy for Spinocerebellar Ataxia
The company is hoping to be the 2nd Taiwanese cell therapy approved abroad.
UniXell Biotechnology Nabs IND Clearance for its iPSC Parkinsons Therapy, UX-DA003
The Chinese company also received an IND in China a few weeks ago. Supported by good preclinical data, they'll advance clinical trials in both countries soon.
First Patient Dosed in Neural Stem Cell Therapy for Huntington’s Trial at UCI Health
The embryonic-derived cell therapy is implanted directly into the brain, and this early trial hopes to establish safety and baseline efficacy.
Hope Biosciences Publishes Positive Results from Stem Cells for TBI Study
The published Phase I/IIa study found that MSC therapy reduced markers of brain inflammation and improved depression, fatigue, pain, and imaging biomarkers in adults with chronic traumatic brain injury, supporting ongoing larger...
TriCelX Nabs FDA Clearance for Phase 1/2 of First-in-Indication Cell Therapy Trial for CTE
Developed in hand with the DoD, the company is hoping to lay the groundwork for cell therapy in concussive injuries for soldiers, athletes, and the broader population.
Hopstem Bio Nabs Phase 2 Approval for its iPSC-Derived Neural Cell Therapy for Chronic Ischemic Stroke
Their Chinese Phase 1 reportedly showed motor improvement in 90% of patients. With that data in hand, the FDA is allowing them to move forward out West.
