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

Phase 1

• Conditions: HAM
• Interventions: Biological: NK cells; Biological: amniotic epithelial cells

• Registration Number: NCT02961712
• Lead Sponsor: The Second Affiliated Hospital of Fujian Medical University

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.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cell therapy	NK cells	NK cells and amniotic epithelial cells
cell therapy	amniotic epithelial cells	NK cells and amniotic epithelial cells

Primary Outcome Measures

Name	Time	Method
change of Osame's Motor Disability Score	1 year	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

Name	Time	Method
HTLV-1 antibody titer in cerebrospinal fluid	1 year
HTLV-1 antibody titer in serum	1 year
HTLV-1 proviral load in blood	1 year

Trial Locations

Locations (1)

The Second Affiliated Hospital of Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China