CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
human umbilical cord blood derived mesenchymal stem cells +1 morebiological
Likely dose
Normal saline 2mLfrom 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/NCT02054208
NCT02054208Phase 2Completed
CompareCT.gov

A Double-blind, Single-center, Phase 1/2a Clinical Trial to Evaluate the Safety and Exploratory Efficacy of Intraventricular Administrations of NEUROSTEM® Versus Placebo Via an Ommaya Reservoir in Patients With Alzheimer's Disease

Medipost Co Ltd.·interventional·Posted Feb 4, 2014·Updated Aug 28, 2020

In Brief

A Phase 2 clinical trial evaluating human umbilical cord blood derived mesenchymal stem cells and Normal saline 2mL for Alzheimer's Disease. Completed, enrolled 46 participants across 1 site.

Detailed Summary

This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity (DLT), and exploratory efficacy of three repeated intraventricular administrations of NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2014
Enrollment StartMar 1, 2014
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 12.4 years ago

Interventions

human umbilical cord blood derived mesenchymal stem cellsbiological

Low dose: 1 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals High dose: 3 x 10\^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Normal saline 2mLother

Intraventricular administrations of 2mL Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations