Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®

Alzheimer's Disease Clinical Trial

Official title:

Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04954534
• Other study ID #: SARC-CR-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Samsung Medical Center
• Contact: Heejin kim, MD
• Phone: +82-2-3410-1947
• Email: evekhj[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM®

2. 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:

1. History of stroke within 3 months prior to study enrollment

2. Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1

3. Severe kidney disorder (serum creatinine =1.5mg/dL) at Visit 1

4. Abnormal Laboratory findings at Visit 1

• Hemoglobin < 9.5 g/dL for male and <9.0 g/dL for female
• Total WBC Count < 3000/mm3
• Total Bilirubin >= 3 mg/dL

5. Suspected active lung disease based on chest X-ray at Visit 1

6. Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of < 137,000/mm3, PT = 1.5 INR, or aPTT = 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)

7. Diagnosis of cancer (of any body system, including brain tumor)

8. Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)

9. Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	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	The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.	4weeks,8weeks,12weeks,24 weeks after the first dose
Secondary	Change in CDR-SOB	The CDR-SOB(Clinical Dementia Rating, Sum of Boxes) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.	24 weeks after the first dose
Secondary	Change from the baseline in K-MMSE(korean version)	The MMSE(Mini-Mental State Examination) is a brief, practical test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function	24 weeks after the first dose
Secondary	Change from the baseline in CGA-NPI	Caregiver-administered Neuropsychiatric Inventory, Measure abnormal behavior. The score range is 0-144. A higher score means severe abnormal behavior.	24 weeks after the first dose
Secondary	Change from the baseline in SIB	The Severe Impairment Battery (SIB) is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best)	24 weeks after the first dose
Secondary	ADAS-Cog Response Rate	Alzheimer's Disease assessment Scale-Cognitive Subscale	The ADAS-cog response is defined as no worsening (no change or improvement on ADAS-cog score) of the ADAS-cog score at 24 weeks after the first administration compared to the baseline
Secondary	Change in CIBIC-plus	The Clinician's Interview-Based Impression of Change-plus(CIBIC-plus) is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).	24 weeks after the first dose
Secondary	Change from the baseline in CSF biomarkers	biomakrers analysis (Amyloid beta 42, Phosphorylated tau, Total tau, RBC, WBC, Protein, Glucose)	24 weeks after the first dose