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An Open-labeled Phase II Study to Evaluate the Efficacy and Safety of GXNPC-1 (Autologous Adipose-derived Stem Cells) in Patients With Chronic Stroke

2019-09-18 03:27:41 | BioPortfolio

Summary

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

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

Conditions

Chronic Stroke

Intervention

GXNPC1

Status

Not yet recruiting

Source

Gwo Xi Stem Cell Applied Technology Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:41-0400

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Medical and Biotech [MESH] Definitions

Diseases of long duration and generally slow progression. The four main types of noncommunicable diseases are CARDIOVASCULAR DISEASES (e.g., heart attacks and stroke), CANCER, chronic respiratory diseases (e.g., CHRONIC OBSTRUCTIVE PULMONARY DISEASE and ASTHMA) and DIABETES MELLITUS.

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