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| Name | Class |
|---|---|
| Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cell therapy | Experimental | NK cells and amniotic epithelial cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK cells | Biological | single intravenous injection of NK cells (0.9~1*10^9) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HTLV-1 antibody titer in serum | 1 year | |
| HTLV-1 antibody titer in cerebrospinal fluid | 1 year | |
| HTLV-1 proviral load in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yimin Zeng, Dr. | Contact | 0595-22766122 | zeng_yi_ming@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongzhi Gao, Dr. | The Second Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Fujian Medical University | Recruiting | Quanzhou | Fujian | 362000 | China |
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| amniotic epithelial cells |
| Biological |
single intrathecal injection of amniotic epithelial cells |
|
| 1 year |