Brigham and Women's autologous iPSC dopamine cells

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

Penelope Hallett (McLean Hospital, sponsor-investigator on the registry), with neurosurgeon John Rolston as principal investigator at Brigham and Women's Hospital. The method comes from Ole Isacson's lab at McLean (not directly involved in the trial). Oryon Cell Therapies, which holds the licence, and NINDS (a CREATE Bio grant awarded in 2020) are registry collaborators. Registered as NCT06422208.

What happened

Blood cells from each participant are reprogrammed into induced pluripotent stem cells (iPSCs), grown into midbrain dopamine neurons, frozen, and injected into the putamen, the brain's movement hub. Because they are the patient's own cells, the team says no anti-rejection drugs are needed. The FDA authorised the trial on 23 August 2023 and the first patient was treated on 9 September 2024 (Mass General Brigham release, undated; search results date it March 2025).

The registry (updated 15 Sep 2026) describes 12 people in one group. Six have had a graft into one putamen. Six more are to receive grafts into both putamina in one operation. Status is "enrolling by invitation". Eligibility: age 55 to 80, Parkinson's for at least 5 years, at least 30% motor improvement on levodopa, no prior brain surgery or deep brain stimulation. The primary outcome is safety (serious adverse events at 12 and 18 months). Secondary outcomes at 18 months include the motor score, on and off time, levodopa dose and dyskinesia. The Mass General Brigham release said three of six planned Phase 1 participants had been treated at the time.

Why it moved us toward a cure

The 2020 single-patient graft (landmark 73) made cells from skin; this trial uses blood and tests the idea in a group. It runs beside the Mass General skin-cell trial (landmark 301) and Aspen's ASPIRO (landmark 76). Together they test whether a person's own cells can restore dopamine without immunosuppression.

Outcome

Pending; no results reported. The design is open label, one arm, with no control group, so it can show safety and graft survival but not benefit.

Sources

• ClinicalTrials.gov NCT06422208 (API checked 19 Oct 2026)
• Mass General Brigham: clinical trial tests novel stem cell treatment for Parkinson's
• Not yet verified: the date of the Mass General Brigham release; the number treated since; any results; the registry's statement of Phase 1 versus the "Phase 1/2a" in its summary.