Back to results

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

Primary Purpose

Refractory Systemic Lupus Erythematosus

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Allogeneic MSC (AlloMSC)

About this trial

This is an interventional treatment trial for Refractory Systemic Lupus Erythematosus focused on measuring Lupus Erythematosus,Systemic, Lupus Nephritis, Mesenchymal Stem Cells, Transplantation

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Rheumatology and Immunology, Nanjing University Medical College Affiliated Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

Lupus serology (ANA, dsDNA, C3, C4)

Renal function (GFR, BUN, urinalysis)

Secondary Outcome Measures

Percentage of systemic T regulatory population

Full Information

NCT ID

NCT00698191

First Posted

June 13, 2008

Last Updated

June 16, 2008

Sponsor

Nanjing Medical University

Collaborators

National Natural Science Foundation of China

1. Study Identification

Unique Protocol Identification Number

NCT00698191

Brief Title

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

Official Title

Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing Medical University

Collaborators

National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Systemic Lupus Erythematosus

Keywords

Lupus Erythematosus,Systemic, Lupus Nephritis, Mesenchymal Stem Cells, Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Allogeneic MSC (AlloMSC)

Intervention Description

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

Primary Outcome Measure Information:

Title

Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

Time Frame

Monthly

Title

Lupus serology (ANA, dsDNA, C3, C4)

Time Frame

Monthly

Title

Renal function (GFR, BUN, urinalysis)

Time Frame

Monthly

Secondary Outcome Measure Information:

Title

Percentage of systemic T regulatory population

Time Frame

Every 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sun Lingyun, MD

Phone

+86 25 83105219

lingyunsun2001@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lingyun Sun, M.D.

Organizational Affiliation

Nanjing University Medical College Affiliated Drum Tower Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Department of Rheumatology and Immunology, Nanjing University Medical College Affiliated Drum Tower Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sun Lingyun, MD

Phone

+86 25 83105219

lingyunsun2001@yahoo.com.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

18389442

Citation

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. doi: 10.1080/08820130801973328.

Results Reference

background

PubMed Identifier

18061155

Citation

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. doi: 10.1016/j.cellimm.2007.10.004. Epub 2007 Dec 3.

Results Reference

background

PubMed Identifier

17402368

Citation

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. doi: 10.1177/0961203306075793.

Results Reference

background

PubMed Identifier

30428931

Citation

Liang J, Zhang H, Kong W, Deng W, Wang D, Feng X, Zhao C, Hua B, Wang H, Sun L. Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study. Stem Cell Res Ther. 2018 Nov 14;9(1):312. doi: 10.1186/s13287-018-1053-4.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs