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Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

2014-07-23 22:00:42 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS.

This study consists of 2 steps. First step is a safety study of the intrathecal(IT) transplantation of "HYNR-CS inj" in 7 patients with ALS. Safety will be evaluated with adverse effect and clinical laboratory test.

Second step is to compare the efficacy and safety between test group and control group of total 64 patients with ALS.

Description

Amyotrophic lateral sclerosis is a progressive neurodegenerative disease characterized by motor neuron loss. Despite of many trials for disease-modifying, no treatment has so far changed natural course of disease.

We have performed the pre-clinical and clinical studies using autologous bone marrow-derived stem cells in ALS. We could get the evidence that autologous bone marrow-derived stem cells have dose-dependent effects on SOD1 mice via intrathecal injection. In our results of clinical trial, intrathecal injection of autologous bone marrow-derived stem cells could slow down disease progression and might be used as a disease modifying strategy in patients with ALS.

This study is to evaluate safety and efficacy of HYNR-CS inj(autologous bone marrow-derived stem cells) in patients with ALS.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Amyotrophic Lateral Sclerosis

Intervention

HYNR-CS inj, Control group

Location

Hanyang University Hospital
Seoul
Korea, Republic of
133-792

Status

Active, not recruiting

Source

Corestem, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T22:00:42-0400

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