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Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)

Primary Purpose

HAM

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NK cells
amniotic epithelial cells
Sponsored by
The Second Affiliated Hospital of Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HAM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

  • HIV infection
  • Hepatitis B & C viral infections
  • Pregnant

Sites / Locations

  • The Second Affiliated Hospital of Fujian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cell therapy

Arm Description

NK cells and amniotic epithelial cells

Outcomes

Primary Outcome Measures

change of Osame's Motor Disability Score
The score were defined as follows: 0, no disability; 1, walking slow; 2, a little trouble when walking; 3, unable to run; 4, needs guardrail while going up the stairs; 5, needs one hand support while walking; 6, needs two hands support while walking (> 10 m); and 7, needs two hands support while walking (< 10 m); 8, needs two hands support while walking (< 5 m); 9, unable to walk but can crawl; 10, unable to crawl but can move; 11, unable to move but can roll over on the bed; 12 unable to roll over; 13, unable to flex toes

Secondary Outcome Measures

HTLV-1 antibody titer in serum
HTLV-1 antibody titer in cerebrospinal fluid
HTLV-1 proviral load in blood

Full Information

First Posted
November 3, 2016
Last Updated
April 24, 2017
Sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT02961712
Brief Title
Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)
Official Title
Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Fujian Medical University
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HAM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cell therapy
Arm Type
Experimental
Arm Description
NK cells and amniotic epithelial cells
Intervention Type
Biological
Intervention Name(s)
NK cells
Intervention Description
single intravenous injection of NK cells (0.9~1*10^9)
Intervention Type
Biological
Intervention Name(s)
amniotic epithelial cells
Intervention Description
single intrathecal injection of amniotic epithelial cells
Primary Outcome Measure Information:
Title
change of Osame's Motor Disability Score
Description
The score were defined as follows: 0, no disability; 1, walking slow; 2, a little trouble when walking; 3, unable to run; 4, needs guardrail while going up the stairs; 5, needs one hand support while walking; 6, needs two hands support while walking (> 10 m); and 7, needs two hands support while walking (< 10 m); 8, needs two hands support while walking (< 5 m); 9, unable to walk but can crawl; 10, unable to crawl but can move; 11, unable to move but can roll over on the bed; 12 unable to roll over; 13, unable to flex toes
Time Frame
1 year
Secondary Outcome Measure Information:
Title
HTLV-1 antibody titer in serum
Time Frame
1 year
Title
HTLV-1 antibody titer in cerebrospinal fluid
Time Frame
1 year
Title
HTLV-1 proviral load in blood
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of HTLV-1 associated myelopathy Exclusion Criteria: HIV infection Hepatitis B & C viral infections Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yimin Zeng, Dr.
Phone
0595-22766122
Email
zeng_yi_ming@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhi Gao, Dr.
Organizational Affiliation
The Second Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Fujian Medical University
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhi Gao, Dr.
Phone
0595-22766122
Email
1564747628@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)

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