# XellSmart's XS411 Cell Therapy Adds Over Five Good Hours a Day in Phase I > XellSmart's off-the-shelf XS411 cell therapy added more than five extra hours of good ON time a day in nine Phase I Parkinson's patients, the company said. - Published: 2026-10-27T18:27:10+00:00 - Section: Research & Clinical Trials - Author: News Desk - URL: https://newsforagent.com/news/2026-10-27/xellsmart-xs411-parkinsons-phase-one - Source: [Longevity.Technology](https://longevity.technology/news/xellsmarts-parkinsons-cell-shot-adds-5-good-hours-a-day/) ## Key takeaways - Nine Phase I patients on XS411 gained an average of more than five extra hours of good ON time a day at six months. - XellSmart finished enrolling all 30 participants in its randomized Phase II trial in China, with follow-up under way. - XS411 holds FDA Fast Track Designation and funding under China's National Major Innovative Drug Program. [XellSmart](https://akta.pro/company-profiles/00024jj/xellsmart)'s off-the-shelf Parkinson's cell therapy XS411 added an average of more than five extra hours of good ON time a day at six months in nine Phase I patients, the company said. [Longevity.Technology](https://longevity.technology/news/xellsmarts-parkinsons-cell-shot-adds-5-good-hours-a-day/) reported the data were presented at the International Congress of Parkinson's Disease and Movement Disorders, alongside news that the company finished enrolling its Phase II trial in China. ## What XS411 Did in Nine Patients XellSmart is a Suzhou-based clinical-stage biopharma developing allogeneic off-the-shelf iPSC-derived cell therapies for Parkinson's disease, ALS and spinal cord injury, according to [company records](https://akta.pro/company-data). The nine Phase I participants had lived with Parkinson's for about ten years each and sat at stages 3 to 4 on the Hoehn-Yahr scale when off medication. After a single transplant of XS411, they gained more than five extra hours of good ON time a day at six months, meaning time with symptoms controlled and no troublesome involuntary movements by the company's definition. XS411 starts with induced pluripotent stem cells coaxed into dopamine-making neurons and is injected into the putamen on both sides of the brain. The therapy was built to work without an immune match between donor and patient, with patients receiving a standardized immunosuppressive regimen instead. Dr Dongning Su from Beijing Tiantan Hospital presented the clinical data on XS411 on behalf of XellSmart. Across three dose groups, XellSmart reported no dose-limiting toxicities, no serious adverse events and no adverse events judged related to XS411 over follow-up. MRI scans showed no abnormal overgrowth or tumors, and nobody developed graft-induced dyskinesia. OFF-state MDS-UPDRS Part III scores improved by more than 30 points on average at six months, and every participant beat published thresholds for a clinically meaningful change. ¹⁸F-DOPA PET imaging showed elevated tracer uptake at the transplant site. ## XellSmart's Phase II Design and Funding Company records show XellSmart launched a multicenter Phase II registrational trial for XS411 in primary Parkinson's disease in April 2026, enrolling 30 patients aged 50-75 in a randomized 2:1 design over a 12-month assessment period, according to akta.pro company records. The same records list an approximately RMB 500 million (about USD 72.6 million) Series B+ funding round closed in April 2026, led by China National Venture Capital and Jiangsu Industrial Investment Social Security Fund. All 30 planned Phase II participants are enrolled, randomly assigned and compared side by side under a PROBE design in which patients and doctors know who received the cells but outcome scorers do not. XellSmart says it is the first stem cell trial in Parkinson's built that way. Beijing Tiantan Hospital leads, with Peking Union Medical College Hospital, the Second Affiliated Hospital of Soochow University and Jiangsu Province Hospital as sub-centers. ## FDA Fast Track and China Funding In August 2026, Longevity.Technology reported that the US Food and Drug Administration granted Fast Track Designation to XS411 for the treatment of Parkinson's disease, a status the outlet said enables intensive agency interactions, rolling biologics license application submission and potential Priority Review. XS411 also received funding under China's National Major Innovative Drug Program, kicked off in June, and in July it received FDA Fast Track Designation after trial clearance in both China and the US, the company said. ## XS411 Phase II Follow-Up Transplants in the Phase II treatment group are finished and follow-up is under way, with the trial's 12-month assessment period running. ## Companies in this story - [XellSmart company profile](https://akta.pro/company-profiles/00024jj/xellsmart) · website: http://www.xellsmart.com --- News for Agent · https://newsforagent.com/llms.txt