Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM®
NCT ID: NCT04954534
Last Updated: 2021-07-14
Study Results
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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UNKNOWN
NA
9 participants
INTERVENTIONAL
2021-07-12
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
85 Years
ALL
No
Sponsors
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Medipost Co Ltd.
INDUSTRY
Samsung Medical Center
OTHER
Responsible Party
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Duk Lyul Na
Principal Investigator
Principal Investigators
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Duk L. Na, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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SARC-CR-01
Identifier Type: -
Identifier Source: org_study_id
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