The objective of the study is to evaluate the safety and the potential therapeutic effects of
CB-AC-02 Intravenous Transplantation in patients with Alzheimer' disease comprised of 2
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Full eligibility criteria for NCT02899091
Ages eligible for Study
50 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Korean male or female at 50+ years of age at the time of screening visit
Diagnosis of Probable Alzheimer disease (probable AD) according to NINCDS-ADRDA criteria at Screening visit
Positive for Amyloid on amyloid-ligand PET
A subject with the imaging findings of Alzheimer's disease as confirmed by MRI or PET
Presence of brain atrophy on brain MRI by visual assessment
Presence of reduced brain glucose metabolism in bilateral temporal-parietal lobe on FDG-PET
Korea Mini-Mental State Examination (KMMSE) score of 10-26 at time of screening visit
Presence of caregiver who can provide information on the subject's condition
Subject who has been taking stable dose of Alzheimer medication for last 2 months or more
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)
Concurrent Dementia as a result of other disorders [i.e. infectious disease of the central nervous system such as HIV, syphilis, head injury, Creutzfeld-Jacob disease, Picks disease, Huntington's disease, Parkinson's disease, other subdural hematoma, hydrocephalus and structural brain lesions, drug addiction, alcoholism, substance abuse, thyroid disease, parathyroid disease, vitamins and other nutritional deficiencies and vascular etc.]
Subject with vascular dementia as determined by the clinical criteria of DSM-IV and the imaging criteria of Erkinkuntii
Subject with severe white matter hyperintensities (i.e. ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths)
Abnormal laboratory findings at screening visit: A. ALT or AST ≥ 2.5 times the upper limit of normal value B. Serum creatinine ≥ 1.5 times the upper limit of normal value C. Total bilirubin ≥ 2 times the upper limit of normal value D. Total WBC counts < 3,000/㎣ E. Hemoglobin <9.5g/dL in men or <9.0g/dL in women F. Platelet count < 150,000/㎣ at screening visit G. PT (INR) ≥ 1.5 or aPTT ≥ 1.5 times the upper limit of normal value
Subjects who are positive for HIV, syphilis or active HBV, HCV infection
Subjects in poor medical condition or subjects with severe cardiovascular, gastrointestinal, pulmonary or endocrinologic disease A. Suspected active active lung disease on chest X-ray at screening visit B. Diagnosis of cancer (except for the subjects who remains in complete remission for 5 years or more )
Subject with concurrent unstable psychiatric disorder (i.e. severe depression, or schizophrenia, or bipolar disorder, etc)
Pregnant or lactating women
Women of childbearing age who reject to practice contraception with one of the following methods
Use a condom
Use of contraceptive (oral, dermal, or injectable)
Use an intra-uterine contraceptive device
Subjects with a history of alcohol abuse (>30g/day) or drug abuse
Subjects who cannot undergo any of the tests performed in this clinical trial (for example, MRI, CT, PET, CSF study)
Subjects with known allergies to protein products (Bovine serum), antibiotics
(gentamycin) or DMSO
Subjects whom the principal investigator considers inappropriate for participation in theis study
All locations for NCT02899091
Korea, Republic of (1)
Bundang Medical Center
Seongnam-si, Gyeonggi-do, Korea, Republic of
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View full eligibility
Tris trial is registered with FDA with number: NCT02899091. The sponsor of the trial is CHABiotech CO., Ltd and it is looking for 24 volunteers for the current phase.
Official trial title: A Randomized, Double-blind, Placebo-controlled, Phase I / IIa Clinical Trial for Evaluation of Safety and Potential Therapeutic Effect After Transplantation of CB-AC-02 in Patients With Alzheimer's Disease
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