Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis (RA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01547091 |
Recruitment Status : Unknown
Verified March 2013 by Alliancells Bioscience Corporation Limited.
Recruitment status was: Recruiting
First Posted : March 7, 2012
Last Update Posted : June 27, 2013
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) Biological: UC-MSC+DMARDS | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | October 2014 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: UC-MSCs Treatment
Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
|
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. |
Active Comparator: DMARDS
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
|
Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease. |
Active Comparator: UC-MSC+DMARDS
Patients will be treated in combination with UC-MSC and DMARDS.
|
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. |
- Safety of MSC treatment. [ Time Frame: 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.
- RA Serology [ Time Frame: 1, 3 and 6 months ]Rheumatoid Factor, C-reactive protein
- Disease Activity Score (DAS 28) Index Mean Change From Baseline [ Time Frame: 1, 3 and 6 months ]
- Patient's assessment of pain. [ Time Frame: 1, 3 and 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547091
Contact: Mingyuan Wu, MD,PhD | 86-10-63188123 | mingyuan-wu@ouhsc.edu | |
Contact: Haijie Ji, MD | 86-10-63188853 | jihaijie82@sohu.com |
China, Shaanxi | |
The 323 Hospital of Chinese People's Liberation Army | Recruiting |
Xi'an, Shaanxi, China, 710054 | |
Contact: Liming Wang, MD 86-29-84756502 wanglm@fmmu.edu.cn | |
Principal Investigator: Liming Wang, MD |
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. |
Responsible Party: | Alliancells Bioscience Corporation Limited |
ClinicalTrials.gov Identifier: | NCT01547091 |
Other Study ID Numbers: |
Alliancells-1 |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | June 27, 2013 |
Last Verified: | March 2013 |
Mesenchymal Stem Cells Rheumatoid Arthritis |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Antirheumatic Agents |