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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

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HTLV-1 Associated Myelopathy is a chronic disease of the spinal cord, caused by a virus called human T lymphotropic virus type 1(HTLV-1). Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

Detailed Description

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HAM is a chronic disease of the spinal cord, caused by a virus called HTLV-I. Natural Killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. In this trial, the investigators aim to study the therapeutic safety and the effect on HTLV-1 virus. This in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

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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HAM

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cell therapy

NK cells and amniotic epithelial cells

Group Type EXPERIMENTAL

NK cells

Intervention Type BIOLOGICAL

single intravenous injection of NK cells (0.9\~1\*10\^9)

amniotic epithelial cells

Intervention Type BIOLOGICAL

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)

Intervention Type BIOLOGICAL

amniotic epithelial cells

single intrathecal injection of amniotic epithelial cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria

* HIV infection
* Hepatitis B \& C viral infections
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role collaborator

The Second Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yimin Zeng, Dr.

Role: CONTACT

0595-22766122

Facility Contacts

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Hongzhi Gao, Dr.

Role: primary

0595-22766122

Other Identifiers

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NK-HAM

Identifier Type: -

Identifier Source: org_study_id

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