Trial Profile

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of NL003 in Subject With Critical Limb IschemiaRutherford 5

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 03 Jun 2026

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At a glance

Drugs Donaperminogene seltoplasmid (Primary)
Indications Chronic limb-threatening ischemia; Peripheral arterial disorders; Ulcer
Focus Registrational; Therapeutic Use
Acronyms HOPE CLTI-2; Rutherford 5
Sponsors Beijing Northland Biotech

29 May 2026 According to Beijing Northland Biotech media release, the company has officially received approval from the National Medical Products Administration for market launch of its Class 1 innovative therapeutic biological product Sedomino Injection.
19 Jun 2024 Status changed from recruiting to completed.
12 Aug 2022 Trial design and rationale from tow clinical trials (HOPE CLTI-1 and HOPE CLTI-2) published in the American Heart Journal

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