The Safety and The Efficacy Evaluation of NEUROSTEM®-AD in Patients With Alzheimer's Disease

Medipost

Status and phase

Completed

Phase 1

Conditions

Dementia of the Alzheimer's Type

Treatments

Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT01297218

MP-CR-007

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study drug in patients with dementia of Alzheimer's type.

Full description

Most of the treatments for Alzheimer disease are chemical drug that is designed to temporarily increase acetylcholine, based on the cholinergic hypothesis. These drugs can improve the symptoms but is not able to inhibit the disease progression. New drugs from the disease have been developed but they have not been successful yet.

Mesenchymal stem cells (MSC) are capable of differentiating into various tissues. Due to the characteristics of the cells it has been widely investigated in tissue regeneration. In addition, the paracrine effect of MSC in microenvironment has been recently reported. MSC has been developed as an immunomodulation cell therapy product because it has been known that it does not cause immunological rejection in allo- and xeno-transplantation. Clinical studies showed that umbilical cord blood-derived MSC is immunologically stable and not toxic.

This study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study drug in patients with dementia of Alzheimer's type.

Enrollment

9 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Korean men and women who are age 50 or older
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
Positive result of PIB-PET imaging (SUV > 1.5,when comparing the result for the cerebellum with the result for the frontal lobe)
Voluntarily participating subject who sign the consent form

Exclusion criteria

Subject with psychological diseases (i.e. depression, schizophrenia, bipolar disorder, etc)
Subject with dementia caused by other than Alzheimer's disease (i.e. infection of central nervous system, Creutzfeld-Jacob disease, severe head trauma, Pick's disease, Huntington's disease, and Parkinson's disease)
Subject with vascular dementia as determined by the clinical criteria of DSM IV and the imaging criteria of Erkinjuntii
Subject with severe white matter hyperintensities (WMH); Severe WMH is defined that length of the deep white matter is 25 mm or longer and length of the periventricular capping/banding is 10 mm or longer.
Subject who have had stroke in 3 months.
Subject with liver disease (two times higher than normal range of ALT/AST)
Subject with severe kidney failure (1.5mg/dL of serum creatinine or more)
Pregnant women or lactating women
Hemoglobin < 9.5g/dL for men, < 9.0 g/dL for women; Total WBC count < 3000/mm3; Total bilirubin ≥ 3 mg/dL
Subject who is suspect to have active lung diseases, based on check X-ray result from Visit 1
Women of childbearing age who reject to practice contraception
Subject who have been excluded in the subject selection process for this study before
A platelet count < 150,000/mm3; PT ≥ 1.5; INR or aPTT ≥ 1.5 X control
Subject with cancer
History of alcohol or drug abuse
Subject who cannot undergo MRI, CT, or PET screening
Subject who cannot undergo anesthesia or stereotactic brain injection
Subject who is determined inappropriate by the investigators