Landmark 301 · Trial in people
Mass General autologous iPSC implant
It will tell us whether repeating the 2020 one-person graft is safe in up to 8 people over 2 years. It has no control group.
In short
Jeffrey Schweitzer's team at Massachusetts General Hospital is repeating the 2020 one-patient graft of a person's own reprogrammed skin cells in a Phase 1 trial of up to eight people; primary completion is estimated for December 2027.
- What it is
- Trial in people
- Outcome
- Result due Dec 2027
- When
- 2025–2028
- Size
- 8 people · Phase 1
- Approach
- Replace or repair what's lost
- Research lane
- Cell replacement
- Trial registry
- NCT06687837
- 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
Jeffrey Schweitzer (neurosurgeon and sponsor-investigator), with Bob Carter and Todd Herrington (MGH). Registered as NCT06687837.
What happened
Each participant gives a skin sample. The skin cells are reprogrammed into induced pluripotent stem cells (iPSCs) and then into midbrain dopamine progenitors, which are put into the putamen on both sides under general anaesthesia. Because they are the patient's own cells, no anti-rejection drugs are expected (the registry does not say). Two dose groups are planned: 4 million or 8 million cells per side.
Eligible people are aged 45 to 80, at least 5 years from symptom onset, with Hoehn-Yahr stage 3 to 4 when off medication, taking at least 300 mg of levodopa a day and with at least 3 hours of daily "off" time. The primary outcome is safety over 2 years. Secondary outcomes include F-DOPA PET, motor scores and off-hours. The registry start date is 29 April 2025, with status Recruiting at the last update (25 Mar 2026). MGH says the FDA approved its IND and that the trial will enrol eight people.
Why it moved us toward a cure
The single-patient graft (landmark 73) could not show whether the method works for anyone else. This trial tests it in several patients, in parallel with Aspen's ASPIRO (landmark 76) and the Chinese autologous programmes (landmark 298). Similar US registrations, not covered here: a McLean Hospital trial run at Brigham and Women's, using blood-derived cells (NCT06422208, up to 12, started Aug 2024; landmark 347) and UC San Diego's CT1-DAP001 (NCT06482268, 7; landmark 348).
Outcome
Pending; no results reported. Primary completion is estimated for December 2027. Safety is the only primary outcome, and the trial has no control group.
Sources
- ClinicalTrials.gov NCT06687837 (API checked 19 Oct 2026)
- MGH neurosurgery: cell therapy page, via search summary
- Registry records NCT06422208, NCT06482268
- Not yet verified: the MGH page itself (read only through a search summary); IND approval date; number dosed; immunosuppression; funding.
How it connects
Built on
- builds on First graft of a patient's own iPSC neurons · 2020
Led to
None recorded.