HAM
Conditions
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.
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.
Interventions
BIOLOGICALNK cells
single intravenous injection of NK cells (0.9\ 1\*10\^9)
BIOLOGICALamniotic epithelial cells
single intrathecal injection of amniotic epithelial cells
Sponsors
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
The Second Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of HTLV-1 associated myelopathy
Exclusion criteria
* HIV infection * Hepatitis B & C viral infections * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Osame's Motor Disability Score | 1 year | 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 |
Secondary
| Measure | 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 | 1 year |
Countries
China
Contacts
Primary ContactYimin Zeng, Dr.
Outcome results
None listed