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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- Percentage of systemic T regulatory population [ Time Frame: Every 3 months ]
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
|Contact: Sun Lingyun, MD||+86 25 email@example.com|
|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 firstname.lastname@example.org|
|Study Director:||Lingyun Sun, M.D.||Nanjing University Medical College Affiliated Drum Tower Hospital|