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

NCT01547091 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-06-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)

-The UC-MSCs will be infused intravenously(single dose, 4x10\^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.

DRUG

Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)

-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.

BIOLOGICAL

UC-MSC+DMARDS

The UC-MSCs will be infused intravenously(single dose, 4x10\^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.Meanwhile,patients will be treated by conventionally drugs if the disease is still not alleviated.

Sponsors & Collaborators

  • Alliancells Bioscience Corporation Limited

    lead INDUSTRY

Principal Investigators

  • Mingyuan Wu, MD,PhD · Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd

  • Yongjun Liu, MD,PhD · Alliancells Biosciences Co., Ltd

  • Liming Wang, MD · The 323 Hospital of Chinese People's Liberation Army

  • Haijie Ji, MD · Alliancells Biosciences Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547091 on ClinicalTrials.gov