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Trial record 11 of 670 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Marrow Diseases"

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

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ClinicalTrials.gov Identifier: NCT02961712
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HAM Biological: NK cells Biological: amniotic epithelial cells Phase 1

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy
Study Start Date : July 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. HTLV-1 antibody titer in serum [ Time Frame: 1 year ]
  2. HTLV-1 antibody titer in cerebrospinal fluid [ Time Frame: 1 year ]
  3. HTLV-1 proviral load in blood [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961712


Contacts
Contact: Yimin Zeng, Dr. 0595-22766122 zeng_yi_ming@126.com

Locations
China, Fujian
The Second Affiliated Hospital of Fujian Medical University Recruiting
Quanzhou, Fujian, China, 362000
Contact: Hongzhi Gao, Dr.    0595-22766122    1564747628@qq.com   
Sponsors and Collaborators
The Second Affiliated Hospital of Fujian Medical University
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Investigators
Principal Investigator: Hongzhi Gao, Dr. The Second Affiliated Hospital of Fujian Medical University

Responsible Party: The Second Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT02961712     History of Changes
Other Study ID Numbers: NK-HAM
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases