CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
HYNR-CS inj +1 morebiological
Likely dose
HYNR-CS inj 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01363401
NCT01363401Phase 2Completed
CompareCT.gov

An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis

Corestemchemon, Inc.·interventional·Posted Jun 1, 2011·Updated Mar 17, 2022

In Brief

A Phase 2 clinical trial evaluating HYNR-CS inj and Control group for Amyotrophic Lateral Sclerosis and ALS. Completed, enrolled 72 participants across 1 site.

Detailed 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) injection of "HYNR-CS inj" in 8 patients with ALS. In this phase 1 study, AE, laboratory test, physical examination, vital signs, Electrocardiogram, and Chest X-Ray examination were evaluated in terms of safety. Second step is to compare the efficacy and safety between test group and control group of total 64 patients with ALS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis, ALS
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2011
Enrollment StartFeb 1, 2011
Primary CompletionMay 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.1 years ago

Interventions

HYNR-CS injbiological

Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.

Control groupother

No treatment of HYNR-CS inj