Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Nanjing Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00698191
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

This study will explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of cells with capability to restore a normal immune system that will no longer attack the body.

The stated hypothesis is that the SLE condition is caused by an abnormal immune system that can be restored by replenishing the body with a new population of progenitor cells.


Condition Intervention Phase
Refractory Systemic Lupus Erythematosus
Biological: Allogeneic MSC (AlloMSC)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Lupus serology (ANA, dsDNA, C3, C4) [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Renal function (GFR, BUN, urinalysis) [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of systemic T regulatory population [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Allogeneic MSC (AlloMSC)

Intervention:

Cyclophosphamide will be administered intravenously at at total dose of 0.8-1.8g 24 hours before transplantation.

Allogeneic bone marrow derived mesenchymal stem cells (matched family donors)will be infused intravenously at 106 cells/kg body weight


Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell (AlloMSC) transplantation in patients with refractory SLE. Patients with Lupus nephritis and refractory to corticosteroid or cyclophosphamide trials will be enrolled in this trial. The treatment intervention includes a 24 hour pretreatment with cyclophosphamide followed by AlloMSC transplantation. Patients will be admitted to the in-patient service for the 3-5 days for the transplant treatment and will be followed up in the outpatient clinic. All baseline lupus serology, renal function panels will be obtained at pre-treatment admission. Post-transplantation follow-up visits will be at monthly intervals for lupus serology and renal function tests, and every 3 months for analysis of T regulatory population. The transplanted patients will be evaluated by an integrated team of rheumatologists, hematologists and bone marrow transplant specialists every month for the entire duration of the trial (2 years) and every 6-12 months thereafter.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
  • Lupus nephritis with 24h urine protein≥1g;
  • Refractory disease as determined by failure of the following regimens:

    • Trial of corticosteroids (oral prednisone more than 20 mg/day);
    • Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as MMF 2 g / day, for three months;
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
  • Willing to use contraception throughout the study and for 12 mos following treatment.

Exclusion Criteria:

  • Abnormal liver function (ALT higher than 3 times the normal value);
  • End-stage renal failure;
  • Severe heart and pulmonary failure, or other important organs damage;
  • Undercontrolled infections
  • Pregnant or breast feeding women, male or female who intended to recent pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698191

Contacts
Contact: Sun Lingyun, MD +86 25 83105219 lingyunsun2001@yahoo.com.cn

Locations
China, Jiangsu
Department of Rheumatology and Immunology, Nanjing University Medical College Affiliated Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Sun Lingyun, MD    +86 25 83105219    lingyunsun2001@yahoo.com.cn   
Sponsors and Collaborators
Nanjing Medical University
National Natural Science Foundation of China
Investigators
Study Director: Lingyun Sun, M.D. Nanjing University Medical College Affiliated Drum Tower Hospital
  More Information

Publications:
Responsible Party: Sun, Lingyun/ Prof., Nanjing University Medical College Affiliated Drum Tower Hospital
ClinicalTrials.gov Identifier: NCT00698191     History of Changes
Other Study ID Numbers: NSFC30772014
Study First Received: June 13, 2008
Last Updated: June 16, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing Medical University:
Lupus Erythematosus,Systemic
Lupus Nephritis
Mesenchymal Stem Cells
Transplantation

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 20, 2014