NCT03117738

A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Nature Cell Co. Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	AstroStem	Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
OTHER	Placebo-Control	Saline with 30% auto-serum

Timeline

• Start date: 2017-05-09
• Primary completion: 2019-06-26
• Completion: 2019-08-31
• First posted: 2017-04-18
• Last updated: 2021-08-10
• Results posted: 2021-07-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study