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A Phase 1 Dose-escalation, Single-Center, Open-labeled Study to Evaluate the Safety and Tolerability of Human Induced Pluripotent Stem Cell-derived Human Forebrain Neural Progenitor Cell Injection (hNPC01) in Chronic Ischemic Stroke

Trial Profile

A Phase 1 Dose-escalation, Single-Center, Open-labeled Study to Evaluate the Safety and Tolerability of Human Induced Pluripotent Stem Cell-derived Human Forebrain Neural Progenitor Cell Injection (hNPC01) in Chronic Ischemic Stroke

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Feb 2026

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At a glance

  • Drugs HNPC 01 (Primary)
  • Indications Ischaemic stroke
  • Focus Adverse reactions
  • Sponsors Hopstem Biotechnology

Most Recent Events

  • 21 Jan 2026 Results presented in the Hopstem biotechnology Media Release.
  • 21 Jan 2026 According to a Hopstem biotechnology media release, based on the positive data from the Phase 1 clinical trials in China, FDA has approved Hopstem to initiate a dose-bridging, randomized-controlled, double-blinded, Phase 2 clinical trial in the United States. Hopstem can further determine the key design elements of the Phase 3 clinical trial, such as sample size, in collaboration with the FDA, and then directly expand the Phase 2 trial into the final pivotal 2/3 study
  • 12 Mar 2024 New trial record

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