Clinical Trial: Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis

Brief Summary: 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.

Detailed Summary:

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, Pati
Sponsor: Organ Transplant Institute, China

Current Primary Outcome: the proportion of participants who achieve and maintain remission [ Time Frame: 5 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Organ Transplant Institute, China

Dates:
Date Received: April 14, 2008
Date Started: May 2008
Date Completion: May 2010
Last Updated: April 14, 2008
Last Verified: April 2008