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Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

NCT01758510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-05-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj"), through intrathecal delivery for the treatment in patients with amyotrophic lateral sclerosis(ALS).

This study is an open label, dose up and down study using the 3+3 design to assess the safety of HLA-haplo matched Allogenic Bone Marrow Derived stem cells("HYNR-CS-Allo inj")

Conditions

Interventions

GENETIC

HYNR-CS-Allo

The patients enrolled in the trial will be successively allocated into three cohorts for HYNR-CS-Allo inj., 0.25 X 10\^6 cells/kg, 0.5 X 10\^6 cells/kg, 1 X 10\^6 cells/kg, according to the 3+3, up and down protocol design. The first treatment cohort will be 0.5 X 10\^6 cells/kg dose cohort.

Sponsors & Collaborators

  • Corestemchemon, Inc.

    collaborator INDUSTRY

  • Hanyang University Seoul Hospital

    lead OTHER

Principal Investigators

  • Seung Hyun Kim, M.D., Ph.D · Hanyang University Seoul Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-04-10
Completion
2017-04-10

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01758510 on ClinicalTrials.gov