NouvNeu001 (iRegene)

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

iRegene Therapeutics (Wuhan, China). Sites named in registry or press records: Beijing Hospital, Zhongnan Hospital of Wuhan University, and Weill Cornell Medicine in New York.

What happened

NouvNeu001 is a "human dopaminergic progenitor cell" injection: cells made from induced pluripotent stem cells (iPSCs, adult cells reprogrammed to an embryo-like state) using chemicals rather than added genes, then injected into both putamens (the brain region that needs dopamine). The cells come from a donor, not the patient.

• China's regulator cleared a Phase 1/2 trial in August 2023. The registered study (NCT06167681, Phase 1/2, about 40 planned, still listed as recruiting; last registry update 1 Nov 2024) started on 17 Jan 2024.
• The US FDA cleared an IND (permission to test in people) on 20 June 2024 (company release of 24 June 2024), Fast Track followed in August 2025, and a Regenerative Medicine Advanced Therapy designation was announced in January 2026.
• Registry entries show later studies: NCT07028632 (a Phase 2-labelled study in mid-to-late-stage disease, about 30 people, Beijing Hospital, estimated start June 2025, still "not yet recruiting" and not updated since June 2025), NCT07102342 (US Phase 1/2, Weill Cornell, about 5 people, started 12 Jan 2026, recruiting, immunosuppressant drugs for 24 to 36 weeks), and NCT07550374 (Phase 1 in people who already had deep brain stimulation, about 10, "not yet recruiting", estimated start May 2026, last updated 24 Apr 2026). Trade press reported the first US patient dosed at Weill Cornell in February 2026.
• iRegene says Phase 1 showed safety and gains in the MDS-UPDRS Part III motor score, with no product-related adverse events. The only numbers found are in a 2024 Movement Disorder Society congress abstract: one patient (aged 50 to 75, mid-to-late stage), four weeks after surgery, motor score improved by up to 40% and Hoehn-Yahr stage fell from 2.5 to 1.5, with "good safety and tolerability". Whether immunosuppression was used is not stated there.

Why it moved us toward a cure

It extends the cell-replacement idea from the embryonic-cell and Kyoto work (landmark 10, landmark 30) to a second, independent manufacturer. The company calls it the first chemically induced iPSC therapy cleared for US testing in Parkinson's (its own claim). It is one of several such programmes (landmark 298).

Outcome

Open. All trials are open-label (no sham surgery) and still running, and no peer-reviewed data exist. As with other grafts, they replace lost dopamine cells and do not target the underlying disease process.

Sources

• ClinicalTrials.gov: NCT06167681, NCT07028632, NCT07102342, NCT07550374 (API checked 19 Oct 2026; statuses as in the text)
• BioSpace, iRegene IND release, 24 June 2024
• MDS Congress 2024 abstract 700 (one patient, four weeks)
• Practical Neurology, 26 June 2024
• Pharmaceutical Technology on RMAT, Jan 2026
• Not yet verified: any Phase 1 numbers beyond the one-patient 2024 abstract (a search summary mentions a later abstract with 5 low-dose and 5 high-dose patients, which I could not open); whether the Phase 2 study NCT07028632 has begun; the exact RMAT and Fast Track dates (sources give month only: August 2025 and January 2026); NCT06167681's true current status (last registry update Nov 2024).