Effect of Mesenchymal Stem Cell Transplantation for Lupus Nephritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Organ Transplant Institute, China.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Organ Transplant Institute, China
ClinicalTrials.gov Identifier:
NCT00659217
First received: April 14, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lupus Nephritis
Biological: mesenchymal stem cell
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Organ Transplant Institute, China:

Primary Outcome Measures:
  • the proportion of participants who achieve and maintain remission [ Time Frame: 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: 2
mesenchymal stem cell Autologous MSC transplantation
Biological: mesenchymal stem cell
Autologous MSC transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659217

Contacts
Contact: Jianming Tan, Professor JM Tan, doctor 008613375918000 doctortjm@YAHOO.COM

Locations
China, Fujian
Fuzhou General Hospital Not yet recruiting
Fuzhou, Fujian, China, 350025
Contact: Jianming Tan, professor    008613375918000    doctortjm@YAHOO.COM   
Sponsors and Collaborators
Organ Transplant Institute, China
  More Information

No publications provided

Responsible Party: FUZHOU GENERAL HOSPITAL
ClinicalTrials.gov Identifier: NCT00659217     History of Changes
Other Study ID Numbers: fuzhough0713
Study First Received: April 14, 2008
Last Updated: April 14, 2008
Health Authority: China: Food and Drug Administration
United States: Federal Government

Keywords provided by Organ Transplant Institute, China:
Mesenchymal Stem Cells
lupus Nephritis

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Autoimmune Diseases
Connective Tissue Diseases
Glomerulonephritis
Immune System Diseases
Kidney Diseases
Lupus Erythematosus, Systemic
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014