CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
AstroStem +1 moredrug
Likely dose
Not stated in 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/NCT03117738
NCT03117738Phase 2Completed
CompareCT.gov

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease

Nature Cell Co. Ltd.·interventional·Posted Apr 18, 2017·Updated Aug 10, 2021

In Brief

A Phase 2 clinical trial evaluating AstroStem and Placebo-Control for Alzheimer Disease. Completed, enrolled 21 participants across 3 sites.

Detailed Summary

This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartMay 9, 2017
Primary CompletionJun 26, 2019
Study CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.2 years ago

Interventions

AstroStemdrug

Autologous adipose tissue derived mesenchymal stem cells (AdMSC)

Placebo-Controlother

Saline with 30% auto-serum