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Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

human umbilical cord derived MSC transplantation for SLE

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

15 Years - 60 Years (Child, 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 60 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 mycophenolate mofetil 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 months 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;
Uncontrolled infections
Pregnant or breast feeding women, male or female who intended to recent pregnancy

Sites / Locations

The Affiliated Drum Tower Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

human umbilical cord derived MSC

Arm Description

human umbilical cord derived MSC transplantation for SLE

Outcomes

Primary Outcome Measures

British Isles Lupus Assessment Group score (BILAG)

Secondary Outcome Measures

Lupus serology (Alb, ANA, dsDNA, C3, C4)

Renal function (GFR, Blood Urea Nitrogen, urinalysis)

Full Information

NCT ID

NCT01741857

First Posted

November 26, 2012

Last Updated

November 1, 2013

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

1. Study Identification

Unique Protocol Identification Number

NCT01741857

Brief Title

Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus

Official Title

Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments. The underlying hypothesis is that the active SLE condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Detailed Description

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 mycophenolate mofetil 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 months following treatment

6. Conditions and Keywords

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

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

human umbilical cord derived MSC

Arm Type

Experimental

Arm Description

human umbilical cord derived MSC transplantation for SLE

Intervention Type

Biological

Intervention Name(s)

human umbilical cord derived MSC transplantation for SLE

Other Intervention Name(s)

Allogenic MSC derived from umbilical cord

Primary Outcome Measure Information:

Title

British Isles Lupus Assessment Group score (BILAG)

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Lupus serology (Alb, ANA, dsDNA, C3, C4)

Time Frame

pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation

Title

Renal function (GFR, Blood Urea Nitrogen, urinalysis)

Time Frame

pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation (for GFR assessed at baseline and 12 months after MSCT)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

60 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 60 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 mycophenolate mofetil 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 months 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; Uncontrolled infections Pregnant or breast feeding women, male or female who intended to recent pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lingyun Sun, MD, PhD

Organizational Affiliation

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Affiliated Drum Tower Hospital of Nanjing University Medical School

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

Phone

+86-25-83105209

12. IPD Sharing Statement

Citations:

PubMed Identifier

19489103

Citation

Sun L, Akiyama K, Zhang H, Yamaza T, Hou Y, Zhao S, Xu T, Le A, Shi S. Mesenchymal stem cell transplantation reverses multiorgan dysfunction in systemic lupus erythematosus mice and humans. Stem Cells. 2009 Jun;27(6):1421-32. doi: 10.1002/stem.68.

Results Reference

background

PubMed Identifier

20506343

Citation

Sun L, Wang D, Liang J, Zhang H, Feng X, Wang H, Hua B, Liu B, Ye S, Hu X, Xu W, Zeng X, Hou Y, Gilkeson GS, Silver RM, Lu L, Shi S. Umbilical cord mesenchymal stem cell transplantation in severe and refractory systemic lupus erythematosus. Arthritis Rheum. 2010 Aug;62(8):2467-75. doi: 10.1002/art.27548.

Results Reference

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PubMed Identifier

20517294

Citation

Liang J, Gu F, Wang H, Hua B, Hou Y, Shi S, Lu L, Sun L. Mesenchymal stem cell transplantation for diffuse alveolar hemorrhage in SLE. Nat Rev Rheumatol. 2010 Aug;6(8):486-9. doi: 10.1038/nrrheum.2010.80. Epub 2010 Jun 1.

Results Reference

background

PubMed Identifier

20650877

Citation

Liang J, Zhang H, Hua B, Wang H, Lu L, Shi S, Hou Y, Zeng X, Gilkeson GS, Sun L. Allogenic mesenchymal stem cells transplantation in refractory systemic lupus erythematosus: a pilot clinical study. Ann Rheum Dis. 2010 Aug;69(8):1423-9. doi: 10.1136/ard.2009.123463. Erratum In: Ann Rheum Dis. 2011 Jan;70(1):237.

Results Reference

background

PubMed Identifier

20345339

Citation

Zhang H, Zeng X, Sun L. Allogenic bone-marrow-derived mesenchymal stem cells transplantation as a novel therapy for systemic lupus erythematosus. Expert Opin Biol Ther. 2010 May;10(5):701-9. doi: 10.1517/14712591003769816.

Results Reference

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PubMed Identifier

22302582

Citation

Shi D, Wang D, Li X, Zhang H, Che N, Lu Z, Sun L. Allogeneic transplantation of umbilical cord-derived mesenchymal stem cells for diffuse alveolar hemorrhage in systemic lupus erythematosus. Clin Rheumatol. 2012 May;31(5):841-6. doi: 10.1007/s10067-012-1943-2.

Results Reference

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PubMed Identifier

22414555

Citation

Che N, Li X, Zhou S, Liu R, Shi D, Lu L, Sun L. Umbilical cord mesenchymal stem cells suppress B-cell proliferation and differentiation. Cell Immunol. 2012;274(1-2):46-53. doi: 10.1016/j.cellimm.2012.02.004. Epub 2012 Feb 23.

Results Reference

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PubMed Identifier

22829849

Citation

Wang D, Akiyama K, Zhang H, Yamaza T, Li X, Feng X, Wang H, Hua B, Liu B, Xu H, Chen W, Shi S, Sun L. Double allogenic mesenchymal stem cells transplantations could not enhance therapeutic effect compared with single transplantation in systemic lupus erythematosus. Clin Dev Immunol. 2012;2012:273291. doi: 10.1155/2012/273291. Epub 2012 Jul 9.

Results Reference

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PubMed Identifier

24756936

Citation

Wang D, Feng X, Lu L, Konkel JE, Zhang H, Chen Z, Li X, Gao X, Lu L, Shi S, Chen W, Sun L. A CD8 T cell/indoleamine 2,3-dioxygenase axis is required for mesenchymal stem cell suppression of human systemic lupus erythematosus. Arthritis Rheumatol. 2014 Aug;66(8):2234-45. doi: 10.1002/art.38674.

Results Reference

derived

PubMed Identifier

24661633

Citation

Wang D, Li J, Zhang Y, Zhang M, Chen J, Li X, Hu X, Jiang S, Shi S, Sun L. Umbilical cord mesenchymal stem cell transplantation in active and refractory systemic lupus erythematosus: a multicenter clinical study. Arthritis Res Ther. 2014 Mar 25;16(2):R79. doi: 10.1186/ar4520.

Results Reference

derived

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Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus

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