RNDP-001 (Kenai) REPLACE

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

Kenai Therapeutics (San Diego), with funding from the California Institute for Regenerative Medicine (CIRM; an $8 million award announced 5 Jan 2026) and FUJIFILM Cellular Dynamics, its exclusive manufacturing partner. CIRM names Howard Federoff as principal investigator. Sites listed in the registry include the University of Arizona, USC and Ohio State.

What happened

RNDP-001 is a dopamine progenitor cell product made from induced pluripotent stem cells (iPSCs, adult cells reprogrammed to a stem-cell state) from a donor, then frozen so it can be shipped. It is injected into the putamen, the brain region that loses dopamine.

The trial is NCT07106021: open-label, non-randomised, Phase 1b/2a, up to 12 people aged 45 to 75 with idiopathic (no known gene) Parkinson's, in three groups (low dose, high dose, "best" dose). The primary outcome is safety and tolerability. The primary measure is safety and tolerability from baseline to 15 months after transplant. The registry start date is 17 July 2025, and Clinical Trials Arena reported on 16 Dec 2025 that the first patient had been dosed (no exact date given). The company holds FDA Fast Track designation. Kenai announced on 7 July 2026 that enrolment was complete (no count given). In January 2026 it expected data from all 12 patients in 2026; the July release gives no date, and no data were found. Registry status: active, not recruiting (updated 27 Jul 2026); primary completion estimated September 2027, study completion June 2031.

Why it moved us toward a cure

Bemdaneprocel (landmark 10) uses embryonic stem cells. RNDP-001 uses iPSCs, the route proven in monkeys (landmark 30), in a frozen, ready-to-use form that could treat many patients from one batch. It is a US counterpart to the Chinese programmes (landmark 297, landmark 298).

Outcome

Pending: the registry's primary completion estimate is September 2027, though earlier company guidance pointed to first data in 2026. It is a safety-first trial with no sham control, and the sources read did not say how the immune system will be managed.

Sources

• ClinicalTrials.gov NCT07106021 (API checked 19 Oct 2026)
• Clinical Trials Arena, 16 Dec 2025
• Kenai release, enrolment complete, 7 Jul 2026 (BioSpace) · Kenai release, CIRM award, 5 Jan 2026 (BioSpace)
• CIRM award page
• Not yet verified: immunosuppression plan; how many patients are dosed (enrolment is said to be complete); the Fast Track date; why the registry start (July 2025) precedes first dosing by five months; the 2027 data timing mentioned in one trade report. (A trade summary gave the registry ID NCT06205394; that is an unrelated breast-cancer study, so NCT07106021 stands.)