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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
Sponsor:
Information provided by:
Organ Transplant Institute, China

Tracking Information
First Submitted Date  ICMJE April 14, 2008
First Posted Date  ICMJE April 16, 2008
Last Update Posted Date April 16, 2008
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
the proportion of participants who achieve and maintain remission [ Time Frame: 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2008)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis
Official Title  ICMJE 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 Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE Biological: mesenchymal stem cell
Autologous MSC transplantation
Study Arms  ICMJE Experimental: 2
mesenchymal stem cell Autologous MSC transplantation
Intervention: Biological: mesenchymal stem cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2010
Estimated Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ages 18 to 50 years old.
  2. Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteria for SLE.
  3. Able to give informed consent.
  4. For treatment -refractory lupus nephritis, participants must fail pulse cyclophosphamide, a renal biopsy must be obtained and document either class III or IV glomerulonephritis.

Exclusion Criteria:

  1. Pregnant women.
  2. Previous history of malignancy
  3. Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
  4. Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
  5. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
  6. Transaminases greater than 2 times normal unless due to active lupus.
  7. Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00659217
Other Study ID Numbers  ICMJE fuzhough0713
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FUZHOU GENERAL HOSPITAL
Study Sponsor  ICMJE Organ Transplant Institute, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Organ Transplant Institute, China
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP