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

Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy

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.

Study Overview

• Status: Unknown
• Conditions: HAM
• Intervention / Treatment: Biological: NK cells; Biological: amniotic epithelial cells

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yimin Zeng, Dr.; Phone Number: 0595-22766122; Email: zeng_yi_ming@126.com

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China, 362000
      • Recruiting
      • The Second Affiliated Hospital of Fujian Medical University
      • Contact: Hongzhi Gao, Dr.; Phone Number: 0595-22766122; Email: 1564747628@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Fujian Medical University
• Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Investigators: Principal Investigator: Hongzhi Gao, Dr., The Second Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: NK-HAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED