| First Published on Clinicaltrials.gov: |
5/30/2011 |
| Status: |
Currently Recruiting |
| ClinicalTrials.gov ID: |
NCT01363401 |
| Sponsor: |
Corestem, Inc. |
| Purpose: |
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. |
| Phase: |
I/II |
| Treatment Type: |
Intrathecal injection |
| Trial Type: |
Open Label |
| Estimated Enrollment: |
71 |
| Eligibility: |
25 years to 65 years. Both genders. No healthy volunteers. |
| Details: |
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. |
| Collaborator(s): |
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| Location(s): |
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| Primary Investigator: |
Seung Hyun Kim, M.D., Ph.D.- Hanyang University |
| Contact: |
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| Trial Protocol as Published on Clinicaltrials.gov: |
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| ALS Forum: |
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