Clinical trial NCT01547091: Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Official title: Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Mesenchymal Stem Cells
Rheumatoid Arthritis
Lead sponsor: Alliancells Bioscience Corporation Limited
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Safety of MSC treatment.
timeFrame: six months
Secondary outcomes:
measure: RA Serology
timeFrame: 1, 3 and 6 months
measure: Disease Activity Score (DAS 28) Index Mean Change From Baseline
timeFrame: 1, 3 and 6 months
measure: Patient's assessment of pain.
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The 323 Hospital of Chinese People's Liberation Army
state: Shaanxi
Study officials:
affiliation: Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd
name: Mingyuan Wu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alliancells Biosciences Co., Ltd
name: Yongjun Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The 323 Hospital of Chinese People's Liberation Army
name: Liming Wang, MD
role: STUDY_DIRECTOR
affiliation: Alliancells Biosciences Co., Ltd.
name: Haijie Ji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang H, Wu M, Liu Y. Are mesenchymal stem cells major sources of safe signals in immune system? Cell Immunol. 2012;272(2):112-6. doi: 10.1016/j.cellimm.2011.10.010. Epub 2011 Oct 29.
citation: Wang L, Ji H, Zhou J, Xie J, Zhong Z, Li M, Bai W, Li N, Zhang Z, Wang X, Zhu D, Liu Y, Wu M. Therapeutic potential of umbilical cord mesenchymal stromal cells transplantation for cerebral palsy: a case report. Case Rep Transplant. 2013;2013:146347. doi: 10.1155/2013/146347. Epub 2013 Mar 3.