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

Study Overview
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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.

Official Title
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Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy

Conditions
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HAM

Intervention / Treatment
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* Biological: NK cells
* Biological: amniotic epithelial cells


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cell therapy<br>NK cells and amniotic epithelial cells | Biological: NK cells<br>* single intravenous injection of NK cells (0.9 1*10^9)<br>Biological: amniotic epithelial cells<br>* single intrathecal injection of amniotic epithelial cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HTLV-1 antibody titer in serum |  | 1 year | 
| HTLV-1 antibody titer in cerebrospinal fluid |  | 1 year | 
| HTLV-1 proviral load in blood |  | 1 year |