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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172117
• Other study ID #: MP-CR-010-F/U
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 19, 2017
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2023
• Source: Medipost Co Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medipost Co Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline in ADAS-Cog	Alzheimer's Disease assessment Scale-Cognitive Subscale	24 month after the first dose
Secondary	Change from the baseline in S-IADL	Seoul Instrumental Activities of Daily Living	24 month after the first dose
Secondary	Change from the baseline in K-MMSE	Mini Mental State Exmination Korean version	24 month after the first dose
Secondary	Change from the baseline in CGA-NPI	Caregiver-administered Neuropsychiatric Inventory	24 month after the first dose
Secondary	ADAS-Cog Response Rate	the ADAS-cog score at 24 month after the first administration compared to the baseline	24 month after the first dose
Secondary	Change in CDR-SOB	Clinical Dementia Rating-Sum of Box	24 month after the first dose
Secondary	Change in CIBIC-plus	The Clinician's Interview Based Impression of Change-plus	24 month after the first dose
Secondary	Change in Florbetaben-PET	Florbetaben - Pittsburgh Compound B-positron emission tomography	24 month after the first dose
Secondary	Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)	fluorodeoxyglucose positron emission tomography	24 month after the first dose
Secondary	Change from baseline in MRI (DTI mapping)	MRI Analysis	24 month after the first dose
Secondary	Change from the baseline in CSF biomarkers	biomakrer analysis	24 month after the first dose