NCT04088149

An Open-labeled Phase II Study to Evaluate the Efficacy and Safety of GXNPC-1 in Patients with Chronic Stroke

GXNPC1 Injections for Chronic Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Gwo Xi Stem Cell Applied Technology Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy for subjects with chronic stroke after GXNPC-1 injection.

Detailed description

This is an open-label, single center, sequentially study in subjects with chronic stroke. Considering 20% dropout rate (based on evaluable versus treated patients), approximately 15 subjects will be enrolled, and at least 12 subjects will be evaluable. Cohort 1 will recruit the first 3 evaluable subjects assigned to receive low dose of GXNPC-1. The following 3 evaluable subjects will be enrolled sequentially and treated with high dose of GXNPC-1 in cohort 2. In cohort 3, another 6 evaluable subjects will be enrolled to take high dose of GXNPC-1. There will be 2 parts of this study including GXNPC-1 preparation and GXNPC-1 treatment in chronic stroke subjects, respectively.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
DRUG	GXNPC1	Autologous ADSCs

Timeline

• Start date: 2020-02-06
• Primary completion: 2023-08-15
• Completion: 2024-09-03
• First posted: 2019-09-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: Taiwan