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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Refractory Systemic Lupus Erythematosus Biological: Allogeneic MSC (AlloMSC) Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus
Study Start Date : March 2007
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Biological: Allogeneic MSC (AlloMSC)

Intervention:

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



Outcome Measures

Primary Outcome Measures :
  1. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: Monthly ]
  2. Lupus serology (ANA, dsDNA, C3, C4) [ Time Frame: Monthly ]
  3. Renal function (GFR, BUN, urinalysis) [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. Percentage of systemic T regulatory population [ Time Frame: Every 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00698191


Contacts
Contact: Sun Lingyun, MD +86 25 83105219 lingyunsun2001@yahoo.com.cn

Locations
China, Jiangsu
Department of Rheumatology and Immunology, Nanjing University Medical College Affiliated Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Sun Lingyun, MD    +86 25 83105219    lingyunsun2001@yahoo.com.cn   
Sponsors and Collaborators
Nanjing Medical University
National Natural Science Foundation of China
Investigators
Study Director: Lingyun Sun, M.D. Nanjing University Medical College Affiliated Drum Tower Hospital
More Information

Publications:
Responsible Party: Sun, Lingyun/ Prof., Nanjing University Medical College Affiliated Drum Tower Hospital
ClinicalTrials.gov Identifier: NCT00698191     History of Changes
Other Study ID Numbers: NSFC30772014
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Nanjing Medical University:
Lupus Erythematosus,Systemic
Lupus Nephritis
Mesenchymal Stem Cells
Transplantation

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases