Rheumatoid Arthritis
Conditions
Keywords
Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Rheumatoid Arthritis
Brief 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.
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.
Interventions
BIOLOGICALhUC-MSC + DMARDs
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.
DRUGDMARDs
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
Sponsors
Futian People's Hospital
Shenzhen Hornetcorn Bio-technology Company, LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of adverse events | 12 months | According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RA Serology | 1, 3 ,6 and 12 months | Rheumatoid Factor, C-reactive protein |
| Disease Activity Score (DAS 28) Index | 1, 3, 6 and 12 months | — |
Countries
China
Contacts
Primary ContactWei J Zhong
Outcome results
None listed