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

Alzheimer Disease Clinical Trial

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

Clinical Trial Summary

This is a phase 2b randomized, double-blind, Placebo-controlled study with 2 treatment arms, to compare the efficacy and safety of AstroStem vs. Placebo treatment in patients with mild Alzheimer's Disease(AD). Eligible patients diagnosed with AD within one year of the start of treatment will be enrolled. Patients who are randomized into the treatment group will be administered via intravenously AstroStem every 4 weeks from Week 0 to Week 36. On the other hand, patients who are randomized into the placebo control group will receive Placebo every 4 weeks from Week 0 to Week 36. After the final administration, patients will be scheduled for two follow-up visits, at Weeks 44 and 52, to assess efficacy and safety endpoints.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04482413
Study type Interventional
Source Nature Cell Co. Ltd.
Contact Hugh Lee
Phone 301-540-2600
Email hughlee@kcrnresearch.com
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2023
Completion date December 20, 2024
View Details
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