NCT02961712

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

Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Second Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• HAM

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2016-11-11
• Last updated: 2017-04-26

Locations

1 site across 1 country: China