Kenai Therapeutics; REPLACE Trial; Phase 1, U.S.
Kenai Therapeutics announced first-patient dosing on December 15, 2025 in its Phase 1 REPLACE trial evaluating RNDP-001, an allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neuron therapy for patients with moderate to moderate-severe idiopathic Parkinson's disease.
source: prnewswire.com; sdbj.com
Up to 12 patients planned for the open-label, multi-center study
Safety, tolerability, and early imaging outcomes
source: prnewswire.com; sdbj.com
Regenerative Approach:
The trial is designed to assess safety, tolerability, and early imaging outcomes, with initial data expected in 2026. RNDP-001 aims to restore motor function by replacing lost dopaminergic neurons, representing a regenerative approach rather than symptomatic modulation.
source: clinicaltrialsarena.com
Unlike current Parkinson's therapies that manage symptoms through dopamine replacement or modulation, this iPSC-derived cell therapy targets the underlying neuronal loss; potentially offering durable, disease-modifying benefits for patients.
Cell therapy trials for neurodegenerative diseases require highly specialized site capabilities and precise patient selection. Kitsa's AI-powered platform can help sponsors:
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