Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT00659217|
Recruitment Status : Unknown
Verified April 2008 by Organ Transplant Institute, China.
Recruitment status was: Not yet recruiting
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Biological: mesenchymal stem cell||Phase 1 Phase 2|
Mesenchymal stem cells (MSC), or marrow stromal cells, are multipotential cells that reside within the bone marrow and can be induced to differentiate into various components of the marrow microenvironment, such as bone, adipose and stromal tissues under proper conditions. It has been reported that MSCs can suppress maturation, activation and proliferation of T, B, NK and DC cell in vitro and downregulate immune response in vivo. MSCs are presently being cotransplantated with hematopoietic stem cell, which can facilitates engraftment of hematopoietic stem cells and prevent GVHD. Systemic lupus erythematosus (SLE) is an autoimmune disorder that affects many organ systems. Autoimmune diseases are illnesses that occur when the body's tissues are attacked by its own immune system. Patients with lupus produce abnormal antibodies in their blood that target tissues within their own body. Because the antibodies and accompanying cells of inflammation can involve tissues anywhere in the body, lupus has the potential to affect a variety of areas of the body. The origin of autoantibody production in SLE is unclear but a role has been suggested for an antigen driven process, spontaneous B-cell hyper-responsiveness, or impaired immune regulation.
The BXSB mouse strain spontaneously develops a progressive and lethal autoimmune disease, similar to human SLE. In our previous work we found that transplantation of MSCs could alleviate the symptoms of BXSB mouse.
This study will evaluate the safety and effectiveness of expanded autologous MSC infusions in patients with primary and treatment -refractory SLE. This study will last 2 years. Participants will be assigned to receive either the prednisone (Group 1) or MSC infusions alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, Patients will be clinically assessed and evaluated for MSC and disease response, and participants will undergo kidney biopsies at 12 Months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||May 2010|
mesenchymal stem cell Autologous MSC transplantation
Biological: mesenchymal stem cell
Autologous MSC transplantation
- the proportion of participants who achieve and maintain remission [ Time Frame: 5 ]
- Patient survival [ Time Frame: 5 ]
- Creatinine and proteinuria. [ Time Frame: 5 ]
- SLE disease activity index [ Time Frame: 5 ]
- Serology (ANA, dsDNA) [ Time Frame: 5 ]
- ComplementC3 and C4 [ Time Frame: 5 ]
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): NCT00659217
|Contact: Jianming Tan, Professor JM Tan, doctor||008613375918000||doctortjm@YAHOO.COM|
|Fuzhou General Hospital|
|Fuzhou, Fujian, China, 350025|
|Contact: Jianming Tan, professor 008613375918000 doctortjm@YAHOO.COM|