Stem Cells International

Review Article

Current Perspectives regarding Stem Cell-Based Therapy for Alzheimer’s Disease

Table 1

Main clinical trials of stem cell therapy for Alzheimer’s disease.

Trial number

Study phase (type)

Sponsor

The route of administration

Cell source

Eligibility criteria

Primary outcome measure

Secondary outcome measure

Time frame

Start date

End date

Location

NCT01297218

Phase I

Medipost Co. Ltd.

Intravenous

hUCB-MSC

Dementia as determined by DSM-IV criteria; probable Alzheimer’s disease as determined by NINCDS-ADRDA criteria; K-MMSE score in the range of 10 to 24

Number of participants with adverse events

Changes from the baseline in ADAS-Cog at 12 weeks postdose

12 weeks

2011-02

2012-12 (completed)

Korea

NCT01547689

Phase I/II (open)

Affiliated hospital to the Academy of Military Medical Sciences

Intravenous

hUCB-MSC

Probable Alzheimer’s disease as determined by NINCDS-ADRDA criteria; MMSE score between 3 and 20, both inclusive

Number of participants with adverse events

Changes from the baseline in ADAS-Cog at 10 weeks postdose

10 weeks

2012-03

2016-12 (active, not recruiting)

China

NCT01617577

Phase I/II (crossover)

University of South Florida

Subcutaneous

Filgrastim (G-CSF)

People with probable AD (by NINCDS-ADRDA criteria); MMSE score between 10 and 24

Cognitive measures including ADAS-Cog, selected CANTABS tests

None

2, 4, 14 weeks

2009-06

2012-02 (completed)

USA

NCT01696591

Phase I (case controlled)

Duk Lyul Na

Brain surgery

hUCB-MSC

Subjects who have enrolled in NCT01297218 and who have similar characteristics

Incidence rate of adverse events

ADAS-Cog response rate

24 months

2012-03

2013-09 (unknown)

Korea

NCT02054208

Phase I/II (randomized quadruple blind controlled)

Medipost Co. Ltd.

Intraventricular

hUCB-MSC

Diagnosis of probable Alzheimer type according to NINCDS-ADRDA criteria and K-MMSE score of 18–26 at visit 1

Number of subjects with adverse events

Change from the baseline in ADAS-Cog, S-IADL, K-MMSE, CGA-NPI, and so forth

24 months

2014-02

2019-07 (recruiting)

Korea

NCT02600130

Phase I

Longeveron LLC

Peripheral intravenous

Longeveron MSC

At the time of enrollment, be diagnosed with AD in accordance with the NINCDS-ADRDA criteria; MMSE score between 18 and 24

Incidence of any serious adverse events

Neurologic/neurocognitive assessments, ADAS-Cog 11, and so forth

2, 4, 13, 26, 39, 52 weeks

2016-08

2019-10 (recruiting)

USC

NCT02672306

Phases I, II

South China Research Center for Stem Cell and Regenerative Medicine

Intravenous

hUCB-MSC

A diagnosis of probable AD and mixed dementia according to the criteria of the NINCDS-ADRDA, MMSE score between 3 and 20, both inclusive

Change in ADAS-Cog score

Change in ADCS-CCGIC score, MMSE, ADCS-ADL, and so on

10 weeks

2016-05

2019-10 (not yet recruiting)

China

NCT03172117

Phase I/II (randomized quadruple blind controlled)

Medipost Co. Ltd.

Intraventricular

hUCB-MSC

Diagnosis of probable Alzheimer type according to NINCDS-ADRDA criteria and K-MMSE score of 18–26 at visit 1

Change from the baseline in ADAS-Cog

Change from the baseline in S-IADL, K-MMSE, CGA-NPI, and so forth

24 months

2017-05

2021-12 (recruiting)

Korea

indicates the number of enrollment; AD: Alzheimer’s disease; ADAS-CCGIC: Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change; ADAS-Cog: Alzheimer’s Disease Assessment Scale-Cognitive Subscale; CGA-NPI: Caregiver-Administered Neuropsychiatric Inventory; DSM: Diagnostic and Statistical Manual of Mental Disorders; hUCB-MSC: human umbilical cord blood-derived mesenchymal stem cell; K-MMSE: Korean version of Mini-Mental State Evaluation; MMSE: Mini-Mental State Evaluation; NINCDS-ADRDA: National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association; S-IADL: Seoul-Instrumental Activities of Daily Living. is the follow-up study of clinical trial number 02054208.