Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)
NCT ID: NCT02961712
Last Updated: 2017-04-26
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
PHASE1
15 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
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Detailed Description
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In a single-center, one year open-label trial, 5 HAM patients will be treated with single intravenous injection of NK cells (0.9\~1\*10\^9). Then, the the clinical effect was evaluated by dynamic analysis of Osame's Motor Disability Score and other related physiological indices, such as HTLV-1 antibody titer in blood and cerebrospinal fluid.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cell therapy
NK cells and amniotic epithelial cells
NK cells
single intravenous injection of NK cells (0.9\~1\*10\^9)
amniotic epithelial cells
single intrathecal injection of amniotic epithelial cells
Interventions
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NK cells
single intravenous injection of NK cells (0.9\~1\*10\^9)
amniotic epithelial cells
single intrathecal injection of amniotic epithelial cells
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hepatitis B \& C viral infections
* Pregnant
18 Years
75 Years
ALL
No
Sponsors
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Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
INDUSTRY
The Second Affiliated Hospital of Fujian Medical University
OTHER
Responsible Party
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Principal Investigators
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Hongzhi Gao, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Fujian Medical University
Locations
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The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NK-HAM
Identifier Type: -
Identifier Source: org_study_id
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