Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Recruitment status was Not yet recruiting
Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Manifestations of systemic lupus eryhematosus(SLE) may in most patients be ameliorated with medications that suppress the immune system. Nevertheless, there remains a subset of SLE patients for whom current strategies are insufficient to control disease. The investigators will infuse expanded autologous MSC into patients with lupus Nephritis. The purpose of this trial is to evaluate whether this new therapeutical approach will result in improvement in the lupus disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis|
- the proportion of participants who achieve and maintain remission [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
- Patient survival [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
- Creatinine and proteinuria. [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
- SLE disease activity index [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
- Serology (ANA, dsDNA) [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
- ComplementC3 and C4 [ Time Frame: 5 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
mesenchymal stem cell Autologous MSC transplantation
Biological: mesenchymal stem cell
Autologous MSC transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659217
|Contact: Jianming Tan, Professor JM Tan, doctor||008613375918000||doctortjm@YAHOO.COM|
|Fuzhou General Hospital||Not yet recruiting|
|Fuzhou, Fujian, China, 350025|
|Contact: Jianming Tan, professor 008613375918000 doctortjm@YAHOO.COM|