Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs); Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs); Biological: UC-MSC+DMARDS

• Registration Number: NCT01547091
• Lead Sponsor: Alliancells Bioscience Corporation Limited

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)

Study Timeline

• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-03-03
• Study First Posted: 2012-03-07
• Status Verified: 2013-03
• Study Start: 2013-04
• Last Update Submitted: 2013-06-26
• Last Update Posted: 2013-06-27
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UC-MSCs Treatment	Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)	Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
DMARDS	Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)	Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
UC-MSC+DMARDS	UC-MSC+DMARDS	Patients will be treated in combination with UC-MSC and DMARDS.

Primary Outcome Measures

Name	Time	Method
Safety of MSC treatment.	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 Outcome Measures

Name	Time	Method
Patient's assessment of pain.	1, 3 and 6 months
RA Serology	1, 3 and 6 months	Rheumatoid Factor, C-reactive protein
Disease Activity Score (DAS 28) Index Mean Change From Baseline	1, 3 and 6 months

Trial Locations

Locations (1)

The 323 Hospital of Chinese People's Liberation Army; 🇨🇳 Xi'an, Shaanxi, China