Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
RA
Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Apr 2013
Typical duration for phase_1 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 27, 2013
March 1, 2013
1.5 years
February 22, 2012
June 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of MSC treatment.
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.
six months
Secondary Outcomes (3)
RA Serology
1, 3 and 6 months
Disease Activity Score (DAS 28) Index Mean Change From Baseline
1, 3 and 6 months
Patient's assessment of pain.
1, 3 and 6 months
Study Arms (3)
UC-MSCs Treatment
EXPERIMENTALPatients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
DMARDS
ACTIVE COMPARATORPatients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
UC-MSC+DMARDS
ACTIVE COMPARATORPatients will be treated in combination with UC-MSC and DMARDS.
Interventions
-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.
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The 323 Hospital of Chinese People's Liberation Army
Xi'an, Shaanxi, 710054, China
Related Publications (2)
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.
PMID: 22138499BACKGROUNDWang 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.
PMID: 23533920BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingyuan Wu, MD,PhD
Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd
- PRINCIPAL INVESTIGATOR
Yongjun Liu, MD,PhD
Alliancells Biosciences Co., Ltd
- STUDY DIRECTOR
Liming Wang, MD
The 323 Hospital of Chinese People's Liberation Army
- PRINCIPAL INVESTIGATOR
Haijie Ji, MD
Alliancells Biosciences Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
March 7, 2012
Study Start
April 1, 2013
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
June 27, 2013
Record last verified: 2013-03