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

Medipost

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer's Disease

Treatments: Other: Normal saline 2mL; Biological: human umbilical cord blood derived mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT03172117

MP-CR-010-F/U

Details and patient eligibility

About

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

Full description

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

Enrollment: 36 patients

Sex: All

Ages: 50 to 86 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
• Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
• Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)

Exclusion criteria

• Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
• Other subjects, excluding those listed above, who were deemed unsuitable by the PI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

NEUROSTEM® (hUCB-MSCs)- low dose

Experimental group

Description:

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

Treatment:

Biological: human umbilical cord blood derived mesenchymal stem cells

NEUROSTEM® (hUCB-MSCs) - high dose

Experimental group

Description:

human umbilical cord blood derived mesenchymal stem cells High dose: 3 x 10\^7 cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals

Treatment:

Biological: human umbilical cord blood derived mesenchymal stem cells

Placebo

Placebo Comparator group

Description:

normal saline 2mL, doses separated by 4 weeks for a total of 3 doses

Treatment:

Other: Normal saline 2mL