NCT04482413

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nature Cell Co. Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	AstroStem	Treatment group receive AstroStem(Autologous adipose tissue derived mesenchymal stem cells, AdMSCs) every 4 weeks from Week 0 to Week 36.
DRUG	Placebo	Placebo control group receive 20 mL of Saline and auto serum every 4 weeks from Week 0 to Week 36.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-30
• Completion: 2024-12-20
• First posted: 2020-07-22
• Last updated: 2022-09-28

Regulatory

• FDA-regulated drug study