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

Chronic Stroke Clinical Trial

Official title:
GXNPC1 Injections for Chronic Stroke

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04088149
Study type Interventional
Source Gwo Xi Stem Cell Applied Technology Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 6, 2020
Completion date September 30, 2023
View Details
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