Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
Overview
- Phase
- Phase 1
- Intervention
- Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Alliancells Bioscience Corporation Limited
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Safety of MSC treatment.
- Last Updated
- 12 years ago
Overview
Brief Summary
Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.
Detailed Description
This study was supported by the National Natural Science Foundation of China (30872618)，The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
- •Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
- •Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.
Exclusion Criteria
- •Any history of ongoing, significant or recurring infections.
- •Any active inflammatory diseases other than RA.
- •Significant cardiac or pulmonary disease.
- •End-stage renal failure.
- •Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Arms & Interventions
UC-MSCs Treatment
Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
Intervention: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
DMARDS
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
Intervention: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
UC-MSC+DMARDS
Patients will be treated in combination with UC-MSC and DMARDS.
Intervention: UC-MSC+DMARDS
Outcomes
Primary Outcomes
Safety of MSC treatment.
Time Frame: six months
Adverse Events will be recorded in a patient or clinical investigation subject who administers MSC and will be evaluated a causal relationship with the treatment.
Secondary Outcomes
- Patient's assessment of pain.(1, 3 and 6 months)
- RA Serology(1, 3 and 6 months)
- Disease Activity Score (DAS 28) Index Mean Change From Baseline(1, 3 and 6 months)