NCT03172117

Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 50 Years – 86 Years
• Healthy volunteers: Not accepted

Summary

A long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups for up to 36 months after the initial administration in patients suffering from Alzheimer's disease

Detailed description

The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	human umbilical cord blood derived mesenchymal stem cells	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
OTHER	Normal saline 2mL	Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations

Timeline

• Start date: 2017-05-19
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2017-06-01
• Last updated: 2023-03-15

Locations

1 site across 1 country: South Korea