Safety and Exploratory Efficacy Study of NEUROSTEM® Versus Placebo in Patients With Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-12-31

Brief Summary

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This combined phase 1/2a clinical trial is to investigate the safety, dose limiting toxicity (DLT), and exploratory efficacy of three repeated intraventricular administrations of NEUROSTEM® (human umbilical cord blood-derived mesenchymal stem cells) versus placebo via an Ommaya reservoir at 4 week intervals in patients with Alzheimer's disease.

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Detailed Description

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The study is divided into the 2 stages: dose-escalation in stage 1 and randomized and multiple-dose cohort parallel design in stage 2.The target population for enrollment in this study is patients with mild to moderate Alzheimer's disease.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stage 1: 9 subjects (3 subjects for low dose and 6 subjects for high dose) Stage 2: 36 subjects ( 24 subjects for high dose and 12 subjects for placebo) A total of 45 subjects to be enrolled

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NEUROSTEM (hUCB-MSCs)- low dose

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

Group Type EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cells

Intervention Type BIOLOGICAL

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

NEUROSTEM (hUCB-MSCs) - high dose

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

Group Type EXPERIMENTAL

human umbilical cord blood derived mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal saline 2mL

Intervention Type OTHER

Intraventricular administrations of 2mL Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations

Interventions

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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

Intervention Type BIOLOGICAL

Normal saline 2mL

Intraventricular administrations of 2mL Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations

Intervention Type OTHER

Other Intervention Names

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NEUROSTEM

Eligibility Criteria

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Inclusion Criteria

1. Korean male or female at 50 -85 years of age
2. Diagnosis of Probable Alzheimer type according to NINCDS-ADRDA criteria at Visit 1 (Screening)
3. Korea Mini-Mental State Examination (KMMSE) score of 18 - 26 at Visit 1 (Screening)
4. Positive for Amyloid on PIB-PET or Florbetaben PET
5. A subject who is informed of the clinical trial and signs a consent form (if unable to sign, a consent from a legally acceptable representative is required)

1. Korean male or female at 50 -85 years of age
2. Diagnosis of Probable Alzheimer type or mild cognitive impairment due to Alzheimer's disease (stage A) according to NIA-AA criteria at Visit 1(Screening)
3. Korea Mini-Mental State Examination (KMMSE) score of over 18 at Visit 1 (Screening)
4. Positive for Amyloid on Florbetaben PET
5. A subject with neurodegeneration (mild atrophy of the brain) as confirmed by MRI
6. A subject who is informed of the clinical trial and signs a consent form (if unable to sign, a consent from a legally acceptable representative is required)

Exclusion Criteria

1. Concurrent mental disorder (such as schizophrenia, depression, bi-polar diseases or others) aside from dementia
2. Concurrent dementia as a result of other neurodegenerative disorders (due to infectious disease of the central nervous system such as HIV, syphilis), head injury, Creutzfeld-Jacob disease, Pick's disease, Huntington's disease, or Parkinson's disease
3. Diagnosis of severe white matter hyperintensitivity (WMH) according to CREDOS (Clinical REsearch Center for Dementia of South Korea), which is defined as ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths
4. History of stroke within 3 months prior to study enrollment
5. Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
6. Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1
7. Pregnant or lactating females
8. 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
9. Suspected active lung disease based on chest X-ray at Visit 1
10. Woman of childbearing age who refuses to practice medically acceptable contraceptive method (post menopausal patient with no menstruation for at least 12 months is considered as infertile)
11. History of screening failure for the clinical trial of NEUROSTEM® in the past 6 months
12. Participation in another clinical trial in the past 3 months prior to the beginning (Week 0) of this clinical trial
13. Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of \< 150,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
14. Diagnosis of cancer (of any body system, including brain tumor)
15. Substance/alcohol abuse
16. Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
17. A subject in whom Ommaya reservoir insertion is considered difficult
18. Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No