drugset / Trial / NCT03214146

Safety/Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in ALS

NCT03214146 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNRCS-Allo-ALS-02 inj"), through intrathecal delivery for the repeated treatment after 6 months of first treatment in patients with amyotrophic lateral sclerosis(ALS). This study is an open label, single-dose study to assess the safety and efficacy of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNRCS-Allo-ALS-02 inj")

Timeline

Start
2017-02-01
Primary completion
2019-03-25
Completion
2021-10

Drugs

EvaluationDrugModalityDoseRoute
Subject HYNRCS-Allo inj Cell therapy 1e+06 cells/kg Intrathecal