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Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)

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. Identifier: NCT00698191
Recruitment Status : Unknown
Verified June 2008 by Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
National Natural Science Foundation of China
Information provided by:
Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE June 13, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date June 17, 2008
Study Start Date  ICMJE March 2007
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: Monthly ]
  • Lupus serology (ANA, dsDNA, C3, C4) [ Time Frame: Monthly ]
  • Renal function (GFR, BUN, urinalysis) [ Time Frame: Monthly ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Percentage of systemic T regulatory population [ Time Frame: Every 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus
Brief Summary

This study will explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of cells with capability to restore a normal immune system that will no longer attack the body.

The stated hypothesis is that the SLE condition is caused by an abnormal immune system that can be restored by replenishing the body with a new population of progenitor cells.

Detailed Description The purpose of this study is to evaluate the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell (AlloMSC) transplantation in patients with refractory SLE. Patients with Lupus nephritis and refractory to corticosteroid or cyclophosphamide trials will be enrolled in this trial. The treatment intervention includes a 24 hour pretreatment with cyclophosphamide followed by AlloMSC transplantation. Patients will be admitted to the in-patient service for the 3-5 days for the transplant treatment and will be followed up in the outpatient clinic. All baseline lupus serology, renal function panels will be obtained at pre-treatment admission. Post-transplantation follow-up visits will be at monthly intervals for lupus serology and renal function tests, and every 3 months for analysis of T regulatory population. The transplanted patients will be evaluated by an integrated team of rheumatologists, hematologists and bone marrow transplant specialists every month for the entire duration of the trial (2 years) and every 6-12 months thereafter.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Systemic Lupus Erythematosus
Intervention  ICMJE Biological: Allogeneic MSC (AlloMSC)


Cyclophosphamide will be administered intravenously at at total dose of 0.8-1.8g 24 hours before transplantation.

Allogeneic bone marrow derived mesenchymal stem cells (matched family donors)will be infused intravenously at 106 cells/kg body weight

Study Arms  ICMJE Experimental: 1
Intervention: Biological: Allogeneic MSC (AlloMSC)
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
  • Lupus nephritis with 24h urine protein≥1g;
  • Refractory disease as determined by failure of the following regimens:

    • Trial of corticosteroids (oral prednisone more than 20 mg/day);
    • Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as MMF 2 g / day, for three months;
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
  • Willing to use contraception throughout the study and for 12 mos following treatment.

Exclusion Criteria:

  • Abnormal liver function (ALT higher than 3 times the normal value);
  • End-stage renal failure;
  • Severe heart and pulmonary failure, or other important organs damage;
  • Undercontrolled infections
  • Pregnant or breast feeding women, male or female who intended to recent pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00698191
Other Study ID Numbers  ICMJE NSFC30772014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun, Lingyun/ Prof., Nanjing University Medical College Affiliated Drum Tower Hospital
Study Sponsor  ICMJE Nanjing Medical University
Collaborators  ICMJE National Natural Science Foundation of China
Investigators  ICMJE
Study Director: Lingyun Sun, M.D. Nanjing University Medical College Affiliated Drum Tower Hospital
PRS Account Nanjing Medical University
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP