Landmark 348 · Trial in people
UC San Diego CT1-DAP001 donor iPSC cells
It will tell us whether Kyoto's donor cells are safe in the US and keep a stable size on MRI. It has no control group.
In short
UC San Diego is running the first US test of the donor iPSC dopamine progenitors that Kyoto tested in Japan, in a seven-person open-label trial; primary completion is estimated for December 2027.
- What it is
- Trial in people
- Outcome
- Result due Dec 2027
- When
- 2024–2028
- Size
- 7 people · Phase 1
- Approach
- Replace or repair what's lost
- Research lane
- Cell replacement
- Trial registry
- NCT06482268
- 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
Joseph Ciacci (UC San Diego, principal investigator), at the Sanford Stem Cell Institute CIRM Alpha Clinic. Sumitomo Pharma makes the cells in Japan. Kyoto University's CiRA and the CiRA Foundation supply the iPSC line. Registered as NCT06482268.
What happened
The FDA cleared the IND (the US permission to test a new drug) after a 30-day review. It was submitted in October 2023 and announced on 26 December 2023. The cells come from the CiRA Foundation's donor iPSC stock, not from the patient. Seven people aged 40 to 75, with Parkinson's for at least 5 years and a good response to levodopa, receive about 4.2 to 5.4 million progenitors per side in both putamina and are followed for 24 months.
The registry gives a start date of 1 June 2024, status Recruiting (verified Aug 2026) and primary completion 28 Dec 2027. Primary outcomes are adverse events and graft expansion (more than 3 cm3 on MRI) at 24 months. Secondary outcomes include the motor score off and on medication and dyskinesia. The registry does not say whether immunosuppressant drugs are used; Kyoto's patients took tacrolimus. I found no announcement of a first patient.
Why it moved us toward a cure
It moves the donor-cell approach tested in landmark 300, which won conditional approval in Japan, into a second country and health system.
Outcome
Pending; no results reported. Single arm, no control group, so safety and graft stability are the questions.
Sources
- ClinicalTrials.gov NCT06482268 (API checked 19 Oct 2026)
- CiRA Foundation / Sumitomo Pharma / CiRA joint announcement, 26 Dec 2023
- Not yet verified: immunosuppression plan; whether any patient has been transplanted; results.
How it connects
Built on
- builds on Kyoto iPSC dopamine-cell trial · 2018
Led to
None recorded.