A Phase I/II clinical trial of UX-DA003, an investigational cell-based product for Parkinson's disease, has been registered with ClinicalTrials.gov under identifier NCT07733349. The study, sponsored by Shanghai UniXell Biotechnology Co., Ltd, is listed as not yet recruiting, with an estimated start date of August 3, 2026, an estimated primary completion date of August 31, 2029, and a full estimated completion date of August 31, 2032, according to the registry entry. Its stated purpose is to evaluate the safety, tolerability and preliminary efficacy of UX-DA003 in patients with Parkinson's disease. Despite the word "injection" in its name, UX-DA003 is not a conventional small-molecule drug. According to a company announcement of the product's FDA clearance to begin US trials, UX-DA003 is an allogeneic, induced pluripotent stem cell (iPSC) derived midbrain dopaminergic progenitor cell therapy, built from a donor-derived cell bank rather than the patient's own cells. The same announcement said the US Food and Drug Administration cleared the program in June 2026, following a clearance from China's National Medical Products Administration on June 3, 2026. A report on the FDA clearance described the therapy's aim as replacing the dopamine-producing neurons that are lost in Parkinson's disease. UniXell also has a related, autologous version of the approach, UX-DA001, made from a patient's own cells, which has been in a separate Phase I trial at Ruijin Hospital in Shanghai since March 2025. The distinction matters for how this trial should be read. It joins, rather than departs from, the stem-cell and cell-replacement strategies already being tested for Parkinson's disease; it is not a new drug class in the pharmacological sense. As of this registration, no participants have been enrolled, and the registry entry reviewed did not disclose a target enrollment number, dosing protocol or surgical delivery method. No safety or efficacy results in humans have been reported for UX-DA003 itself.
New Parkinson's Cell Therapy Trial Registered, Not Yet Recruiting
A Phase I/II study of UX-DA003, an injectable stem cell product made by Shanghai's UniXell Biotechnology, has been listed on ClinicalTrials.gov, joining rather than departing from the field's stem-cell efforts.
The trial's own timeline puts its primary completion date more than three years away, in August 2029, meaning any read on safety or benefit for patients is not expected soon.
Sources
- Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease (NCT07733349)
- UniXell Biotechnology Secures FDA IND Clearance for UX-DA003, Achieving China-U.S. Dual Breakthrough in iPSC Parkinson's Therapy
- New Parkinson's stem cell therapy UX-DA003 cleared for US trials