Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE) - Full Text View

Sponsors and Collaborators:	Nanjing Medical University National Natural Science Foundation of China
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00698191

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 I Phase II

MedlinePlus related topics: Lupus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus

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
1: Experimental	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:

Jiang B, Sun L, Hao S, Li X, Xu Y, Hou Y. Estrogen modulates bone marrow-derived DCs in SLE murine model-(NZB x NZW) F1 female mice. Immunol Invest. 2008;37(3):227-43.

Jiang B, Sun L, Hao S, Li X, Hou Y. Estrogen distinctively modulates spleen DC from (NZB x NZW) F1 female mice in various disease development stages. Cell Immunol. 2007 Aug;248(2):95-102. Epub 2007 Dec 3.

Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8.

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

Keywords provided by Nanjing Medical University:

Lupus Erythematosus,Systemic
Lupus Nephritis
Mesenchymal Stem Cells
Transplantation

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Lupus Nephritis
Lupus

Nephritis
Connective Tissue Diseases
Cyclophosphamide

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009