Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Overview
- Phase
- Phase 1
- Intervention
- hUC-MSC + DMARDs
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Severity of adverse events
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
hUC-MSC + DMARDs
Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
Intervention: hUC-MSC + DMARDs
DMARDs
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
Intervention: DMARDs
Outcomes
Primary Outcomes
Severity of adverse events
Time Frame: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Secondary Outcomes
- Disease Activity Score (DAS 28) Index(1, 3, 6 and 12 months)
- RA Serology(1, 3 ,6 and 12 months)