Landmark 298 · Trial in people
Wave of Chinese iPSC dopamine-cell trials
Eight small open-label trials from five companies. Only company press releases report early results, so none has been checked by independent scientists.
In short
Five Chinese companies, besides iRegene, registered eight Phase 1 or Phase 1/2 trials of iPSC-derived dopamine cells in 2025–26, all small and open-label, and only company press releases report early results.
- What it is
- Trial in people
- Outcome
- Mixed or early results
- When
- 2025–2026
- Size
- Phase 2
- Approach
- Replace or repair what's lost
- Research lane
- Cell replacement
- Trial registry
- NCT07080775
- Last checked
- 19 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
Chinese cell-therapy companies and their hospital partners. iRegene's NouvNeu001 has its own file (landmark 297).
What happened
Each trial injects dopamine progenitor cells made from induced pluripotent stem cells (iPSCs, adult cells reprogrammed to a stem-cell state) into the putamen on both sides. Registry data checked 19 Oct 2026:
| Product (sponsor) | Registry ID | Phase | Planned n | Source of cells | Registry status |
|---|---|---|---|---|---|
| XS411 (XellSmart), primary PD | NCT07080775 | 1/2 | 39 (actual) | Donor | Active, not recruiting; started 5 Aug 2025; randomised, with a standard-treatment arm (outcome assessor masked); sponsor XellSmart Therapeutics (Shanghai), with Beijing Tiantan Hospital |
| XS411, early-onset PD | NCT07166757 | 1/2 | 90 | Donor | Recruiting, started 22 Sep 2025; Phase 2 sham-controlled (81) |
| UX-DA001 (UniXell) | NCT06778265 | 1 | 12 | Patient's own | Active, started Mar 2025 |
| UX-DA003 (UniXell) | NCT07733349 | 1/2 | 12 | Donor | Not yet recruiting; estimated start 3 Aug 2026, record last updated 29 Jul 2026 |
| ICA07 (iCamuno) | NCT06821529 | 1 | 12 | Patient's own | Not yet recruiting; record last updated Feb 2025 |
| ALC01 (iCamuno) | NCT07212088 | 1 | 12 | Donor | Not yet recruiting; estimated start 28 Feb 2026, record last updated 11 Feb 2026 |
| NCR201 (Nuwacell) | NCT06978920 | 1 | 48 | iPSC | Recruiting, started 6 Jun 2025 |
| BBM-P002 (Shanghai Xinzhi) | NCT07195825 | 1 | 18 | Not stated | Recruiting, started 27 Dec 2025 |
Company claims: XellSmart says an FDA IND was cleared in January 2025 (no day given), announced FDA Fast Track on 28 July 2026, and announced in July 2026 that enrolment in its China registrational Phase 2 (led by Beijing Tiantan Hospital) was complete. It reports statistically significant gains in off-state motor score in Phase 1, with no figures. UniXell reported one woman's 3-month result at the October 2025 MDS Congress: motor score off medication improved 21 points (47.7%), daily off-time fell 5.33 hours, with graft survival on PET; no immunosuppression is used. None of this is peer reviewed, and one patient proves nothing. UniXell also announced China (3 June 2026) and FDA (release dated 23 June 2026) IND clearance for its donor-cell product UX-DA003 (company release, via BioSpectrum Asia).
Why it moved us toward a cure
The Kyoto trial (landmark 300), bemdaneprocel (landmark 10) and the one-patient autologous graft (landmark 73) showed grafts could be made safely. This wave tests whether many makers can reproduce it, and whether patient-own cells avoid immunosuppression.
Outcome
Open. Safety is the main question; nothing here tests whether grafts slow the disease itself.
Sources
- ClinicalTrials.gov API records for each ID above, checked 19 Oct 2026
- XellSmart Fast Track release, BioSpace, 4 Aug 2026
- NeurologyLive on UX-DA001, 20 Oct 2025 (abstract LBA-14, MDS Congress, Honolulu, 5 to 9 Oct 2025; on medication the motor score improved 8 points, 42.1%)
- UniXell FDA clearance, BioSpectrum Asia, 3 Jul 2026
- Not yet verified: Phase 1 results for XS411, NCR201 and BBM-P002; whether ICA07 and ALC01 have dosed anyone (registry records have not been updated since early 2025 and February 2026); UX-DA001's FDA status; the UX-DA003 FDA clearance rests on a company release as reported by trade press; sample sizes of the company-reported studies. Also in the registry but not covered: Shanghai East Hospital with XellSmart (NCT06145711, 3 people, started Nov 2023) and Royan Institute, Iran (NCT07572071).
How it connects
Built on
- builds on Kyoto iPSC dopamine-cell trial · 2018
- builds on First graft of a patient's own iPSC neurons · 2020
- builds on Bemdaneprocel embryonic stem-cell dopamine neurons · 2025
Led to
None recorded.