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Tracking Information | |||||
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First Received Date † | June 13, 2008 | ||||
Last Updated Date | June 16, 2008 | ||||
Start Date † | March 2007 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00698191 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Percentage of systemic T regulatory population [ Time Frame: Every 3 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE) | ||||
Official Title † | 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. |
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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. |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Refractory Systemic Lupus Erythematosus | ||||
Intervention † | Biological: Allogeneic MSC (AlloMSC) | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 20 | ||||
Estimated Completion Date | December 2012 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 15 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | China | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00698191 | ||||
Responsible Party | Sun, Lingyun/ Prof., Nanjing University Medical College Affiliated Drum Tower Hospital | ||||
Secondary IDs †† | |||||
Study Sponsor † | Nanjing Medical University | ||||
Collaborators †† | National Natural Science Foundation of China | ||||
Investigators † |
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Information Provided By | Nanjing Medical University | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |