HAMPhase 1NCT02961712
Immunotherapy of Natural Killer(NK) Cells in Human T Lymphotropic Virus Type 1(HTLV-1) Associated Myelopathy(HAM)
A Phase 1 study testing NK cells and amniotic epithelial cells in people with HAM, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HAM
- What is being tested?
- NK cells and amniotic epithelial cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HTLV-1 associated myelopathy
Who cannot join
- HIV infection
- Hepatitis B \& C viral infections
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
Hongzhi Gao, Dr., 0595-22766122, 1564747628@qq.com
About this study
Official title: Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy
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.
Read the 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
- Being tested
- NK cells, amniotic epithelial cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cellsBiological
single intravenous injection of NK cells (0.9~1*10^9)
amniotic epithelial cellsBiological
single intrathecal injection of amniotic epithelial cells
| Study group | Role | What they receive |
|---|---|---|
| cell therapy | Experimental | NK cells and amniotic epithelial cells Receives: Biological: NK cells; Biological: amniotic epithelial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
HTLV-1 antibody titer in serum
Measured: 1 year
HTLV-1 antibody titer in cerebrospinal fluid
Measured: 1 year
HTLV-1 proviral load in blood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HAMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Hongzhi Gao, Dr., Principal investigator, The Second Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961712
- Sponsor's protocol ID
- NK-HAM
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Natural Killer in HTLV-1 Associated Myelopathy
- ClinicalTrials.gov ID
- NCT02961712
- Acronym / sponsor ID
- NK-HAM
- Conditions
- HAM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell therapy | Experimental | Biological: NK cells, Biological: amniotic epithelial cellsNK cells and amniotic epithelial cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of HTLV-1 associated myelopathy
Key exclusion criteria (3 listed)
- HIV infection
- Hepatitis B \& C viral infections
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK cellssingle intravenous injection of NK cells (0.9~1*10^9) | Biological | cell therapy |
| amniotic epithelial cellssingle intrathecal injection of amniotic epithelial cells | Biological | cell therapy |
Primary outcome
change of Osame's Motor Disability Score
Time frame: 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
3 secondary outcomes
HTLV-1 antibody titer in serum
Time frame: 1 year
HTLV-1 antibody titer in cerebrospinal fluid
Time frame: 1 year
HTLV-1 proviral load in blood
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for HAM
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HTLV-I Infection, Tropical Spastic Paraparesis
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Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
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RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
HTLV-1 Infection, HTLV I Associated Myelopathies
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Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongzhi Gao, Dr. principal investigator
The Second Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK cells and amniotic epithelial cells in people with HAM, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimin Zeng, Dr. (0595-22766122, zeng_yi_ming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Osame's Motor Disability Score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.