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

Rheumatoid Arthritis Clinical Trial

— RA  

Official title:

Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01547091
• Other study ID #: Alliancells-1
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: February 22, 2012
• Last updated: June 26, 2013
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2013
• Source: Alliancells Bioscience Corporation Limited
• Contact: Mingyuan Wu, MD,PhD
• Phone: 86-10-63188123
• Email: mingyuan-wu[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
China	The 323 Hospital of Chinese People's Liberation Army	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Alliancells Bioscience Corporation Limited

Country where clinical trial is conducted

China, 

References & 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	RA Serology	Rheumatoid Factor, C-reactive protein	1, 3 and 6 months
Secondary	Disease Activity Score (DAS 28) Index Mean Change From Baseline		1, 3 and 6 months
Secondary	Patient's assessment of pain.		1, 3 and 6 months