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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: The Second Affiliated Hospital of Fujian Medical University

Current Primary Outcome: change of Osame's Motor Disability Score [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • HTLV-1 antibody titer in serum [ Time Frame: 1 year ]
  • HTLV-1 antibody titer in cerebrospinal fluid [ Time Frame: 1 year ]
  • HTLV-1 proviral load in blood [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: The Second Affiliated Hospital of Fujian Medical University

Dates:
Date Received: November 3, 2016
Date Started: July 2016
Date Completion: December 2017
Last Updated: April 24, 2017
Last Verified: November 2016