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

HAM Clinical Trial

Official title:

Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961712
• Other study ID #: NK-HAM
• Status: Recruiting
• Phase: Phase 1
• First received: November 3, 2016
• Last updated: April 24, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: The Second Affiliated Hospital of Fujian Medical University
• Contact: Yimin Zeng, Dr.
• Phone: 0595-22766122
• Email: zeng_yi_ming[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

• HIV infection

• Hepatitis B & C viral infections

• Pregnant

Related Conditions & MeSH terms

• HAM
• Spinal Cord Diseases

Intervention

Biological:
• NK cells
single intravenous injection of NK cells (0.9~1*10^9)
• amniotic epithelial cells
single intrathecal injection of amniotic epithelial cells

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Fujian Medical University	Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HTLV-1 antibody titer in serum		1 year
Secondary	HTLV-1 antibody titer in cerebrospinal fluid		1 year
Secondary	HTLV-1 proviral load in blood		1 year