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

NCT02961712 | Unknown Phase 1

• 1 other identifier: NK-HAM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HAM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

cell therapy

EXPERIMENTAL

NK cells and amniotic epithelial cells

Biological: NK cells; Biological: amniotic epithelial cells

Interventions

NK cells BIOLOGICAL

single intravenous injection of NK cells (0.9\~1\*10\^9)

cell therapy

amniotic epithelial cells BIOLOGICAL

single intrathecal injection of amniotic epithelial cells

cell therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of HTLV-1 associated myelopathy

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Fujian Medical University: lead
• Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China: collaborator

Study Sites (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

RECRUITING

Study Officials

• Hongzhi Gao, Dr.

  The Second Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yimin Zeng, Dr.

CONTACT

0595-22766122; zeng_yi_ming@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 11, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 26, 2017

Record last verified: 2016-11

Locations

CN (1)