UX-DA001 / Shanghai Yuesai Biotech - LARVOL DELTA

UX-DA001 (Autologous iPSC Therapy): (The Manila Times) - "Currently in a Phase I clinical trial at Ruijin Hospital (Shanghai). Developed from patients' own cells, this therapy effectively avoids immune rejection. The first enrolled patient has completed one year of follow-up, and preliminary clinical outcomes have confirmed a favorable safety profile."

Trial status • Parkinson's Disease

An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Shanghai UniXell Biotechnology Co., Ltd | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Breakthrough in China: Stem cell therapy achieves efficiency in Parkinson's (The Economic Times) - "Led by neurology specialist Shi Jiong, the team's Phase I clinical trial, underway since mid-2025, has treated six patients, all showing rapid symptom improvements and sustained dopamine signaling boosts in the brain...A standout case is 37-year-old patient Li, who lost motor control at age 22; just three months post-treatment, she achieved near-normal function and returned to daily life. Shi emphasized the method's superior efficiency, achieved through optimized differentiation protocols, positioning USTC ahead of global efforts....UniXell's UX-DA001 iPSC therapy, dosed in March 2025, showed motor gains and dopamine uptake in Phase I, avoiding immunosuppression via patient-derived cells."

P1 data • Parkinson's Disease

Unixell Biotech…announced positive 6-month follow-up data from the first patient in its phase 1 clinical trial for UX-DA001, an iPSC-derived autologous cell therapy for PD. (The Manila Times) - "The patient tolerated the procedure well, with no serious adverse events or adverse events related to the transplanted cells. Significant improvement in motor function: The MDS-UPDRS-III score improved by 21 points during the 'OFF-period' and 9 points during the 'ON-period', representing an improvement ratio exceeding 45% in both states."

P1 data • Parkinson's Disease

UniXell Biotechnology announces the first patient dosed with UX-DA001, an investigational autologous iPSC based cell therapy for the treatment of Parkinson's disease, in its Phase 1 study (The Manila Times) - "Shanghai UniXell Biotechnology Co., Ltd...announced the successful first administration of its proprietary Parkinson's disease cell drug UX-DA001 in China in March 2025. The Phase I clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of UX-DA001 in patients with Parkinson's disease."

Trial status • Parkinson's Disease