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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02961712
Date of registration:	03/11/2016
Prospective Registration:	No
Primary sponsor:	The Second Affiliated Hospital of Fujian Medical University
Public title:	Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)
Scientific title:	Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy
Date of first enrolment:	July 2016
Target sample size:	15
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02961712
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 1

Countries of recruitment
China

Contacts

Name:	Yimin Zeng, Dr.
Address:
Telephone:	0595-22766122
Email:	zeng_yi_ming@126.com
Affiliation:

Name:	Hongzhi Gao, Dr.
Address:
Telephone:	0595-22766122
Email:	1564747628@qq.com
Affiliation:

Name:	Hongzhi Gao, Dr.
Address:
Telephone:
Email:
Affiliation:	The Second Affiliated Hospital of Fujian Medical University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of HTLV-1 associated myelopathy

Exclusion Criteria:

- HIV infection

- Hepatitis B & C viral infections

- Pregnant

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

HAM

Intervention(s)

Biological: amniotic epithelial cells

Biological: NK cells

Primary Outcome(s)

change of Osame's Motor Disability Score [Time Frame: 1 year]

Secondary Outcome(s)

HTLV-1 proviral load in blood [Time Frame: 1 year]

HTLV-1 antibody titer in cerebrospinal fluid [Time Frame: 1 year]

HTLV-1 antibody titer in serum [Time Frame: 1 year]

Secondary ID(s)

NK-HAM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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