Rheumatoid ArthritisPhase 1NCT02643823
Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
A Phase 1 study testing hUC-MSC + DMARDs and DMARDs in people with Rheumatoid Arthritis, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- hUC-MSC + DMARDs and DMARDs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 Rheumatoid Arthritis patient;
- Patients must consent in writing to participate in the study by signing and dating an informed consent document;
- Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
- Stage I and II according to X-ray.
Who cannot join
- History of neurological disease, head injury or psychiatric disorder;
- Pregnant women;
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
- Progressive apoplexy;
- With malignant tumors;
- Patients who had participated in other clinical trials within three months prior to this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth People's Hospital of Shenzhen
Shenzhen, Guangdong, 518000
Hao J, Professor, 0755-83981333, HaoJ@hotmail.com
About this study
Official title: Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.
Read the detailed description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.
- Conditions
- Rheumatoid Arthritis
- Being tested
- hUC-MSC + DMARDs, DMARDs
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUC-MSC + DMARDsBiological
Also called Human Umbilical Cord-Mesenchymal Stem Cells
Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
DMARDsDrug
Also called NSAIDs, Methotrexate
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSC + DMARDs | Experimental | Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up. Receives: Biological: hUC-MSC + DMARDs |
| DMARDs | Active comparator | Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up. Receives: Drug: DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Measured: 12 months
Secondary outcomes (2)
RA Serology
Rheumatoid Factor, C-reactive protein
Measured: 1, 3 ,6 and 12 months
Disease Activity Score (DAS 28) Index
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Futian People's Hospital
- Responsible party
- Sponsor
- Investigators
- Zhong Z Ye, Professor, Principal investigator, Futian People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643823
- Sponsor's protocol ID
- HYK-Rheumatoid Arthritis
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2015
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02643823
- Acronym / sponsor ID
- HYK-Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Keywords
- Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Collaborators
- Futian People's Hospital
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 31 Dec 2015 (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.
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.
Detailed description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hUC-MSC + DMARDs | Experimental | Biological: hUC-MSC + DMARDsPatients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up. |
| DMARDs | Active comparator | Drug: DMARDsPatients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-80 Rheumatoid Arthritis patient;
- Patients must consent in writing to participate in the study by signing and dating an informed consent document;
- Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
- Stage I and II according to X-ray.
Key exclusion criteria (6 listed)
- History of neurological disease, head injury or psychiatric disorder;
- Pregnant women;
- Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
- Progressive apoplexy;
- With malignant tumors;
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 |
|---|---|---|
| hUC-MSC + DMARDsAlso: Human Umbilical Cord-Mesenchymal Stem CellsPatients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. | Biological | hUC-MSC + DMARDs |
| DMARDsAlso: NSAIDs, MethotrexatePatients will be treated by conventional drugs (DMARDs) for alleviating disease. | Drug | DMARDs |
Primary outcome
Severity of adverse events
Time frame: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
2 secondary outcomes
RA Serology
Time frame: 1, 3 ,6 and 12 months
Disease Activity Score (DAS 28) Index
Time frame: 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Zhong Z Ye, Professor principal investigator
Futian People's Hospital
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 hUC-MSC + DMARDs and DMARDs in people with Rheumatoid Arthritis, run by Shenzhen Hornetcorn Bio-technology Company, LTD 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 4 inclusion and 6 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 24 May 2016. 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 Wei J Zhong (+86 0755-83980805, ZhongJW@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of adverse events (time frame: 12 months). 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 24 May 2016.