Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
NCT ID: NCT01547091
Last Updated: 2013-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2013-04-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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UC-MSCs Treatment
Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
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.
DMARDS
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
UC-MSC+DMARDS
Patients will be treated in combination with UC-MSC and DMARDS.
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.
Interventions
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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.
Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Alliancells Bioscience Corporation Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Mingyuan Wu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd
Yongjun Liu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Alliancells Biosciences Co., Ltd
Liming Wang, MD
Role: STUDY_DIRECTOR
The 323 Hospital of Chinese People's Liberation Army
Haijie Ji, MD
Role: PRINCIPAL_INVESTIGATOR
Alliancells Biosciences Co., Ltd.
Locations
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The 323 Hospital of Chinese People's Liberation Army
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Alliancells-1
Identifier Type: -
Identifier Source: org_study_id
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