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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
UC-MSC+DMARDS
Sponsored by
Alliancells Bioscience Corporation Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Mesenchymal Stem Cells, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The 323 Hospital of Chinese People's Liberation ArmyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

UC-MSCs Treatment

DMARDS

UC-MSC+DMARDS

Arm Description

Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.

Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).

Patients will be treated in combination with UC-MSC and DMARDS.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

RA Serology
Rheumatoid Factor, C-reactive protein
Disease Activity Score (DAS 28) Index Mean Change From Baseline
Patient's assessment of pain.

Full Information

First Posted
February 22, 2012
Last Updated
June 26, 2013
Sponsor
Alliancells Bioscience Corporation Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01547091
Brief Title
Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Acronym
RA
Official Title
Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliancells Bioscience Corporation Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Mesenchymal Stem Cells, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs Treatment
Arm Type
Experimental
Arm Description
Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only.
Arm Title
DMARDS
Arm Type
Active Comparator
Arm Description
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs).
Arm Title
UC-MSC+DMARDS
Arm Type
Active Comparator
Arm Description
Patients will be treated in combination with UC-MSC and DMARDS.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
Intervention Description
-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.
Intervention Type
Drug
Intervention Name(s)
Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
Intervention Description
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
Intervention Type
Biological
Intervention Name(s)
UC-MSC+DMARDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of MSC treatment.
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
RA Serology
Description
Rheumatoid Factor, C-reactive protein
Time Frame
1, 3 and 6 months
Title
Disease Activity Score (DAS 28) Index Mean Change From Baseline
Time Frame
1, 3 and 6 months
Title
Patient's assessment of pain.
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyuan Wu, MD,PhD
Phone
86-10-63188123
Email
mingyuan-wu@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Haijie Ji, MD
Phone
86-10-63188853
Email
jihaijie82@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingyuan Wu, MD,PhD
Organizational Affiliation
Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongjun Liu, MD,PhD
Organizational Affiliation
Alliancells Biosciences Co., Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liming Wang, MD
Organizational Affiliation
The 323 Hospital of Chinese People's Liberation Army
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haijie Ji, MD
Organizational Affiliation
Alliancells Biosciences Co., Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 323 Hospital of Chinese People's Liberation Army
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Wang, MD
Phone
86-29-84756502
Email
wanglm@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Liming Wang, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22138499
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.
Results Reference
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PubMed Identifier
23533920
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.
Results Reference
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Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis

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