NCT00698191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

4.8 years

First QC Date

June 13, 2008

Last Update Submit

June 16, 2008

Conditions

Refractory Systemic Lupus Erythematosus

Keywords

Lupus Erythematosus,SystemicLupus NephritisMesenchymal Stem CellsTransplantation

Outcome Measures

Primary Outcomes (3)

  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

    Monthly

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

    Monthly

  • Renal function (GFR, BUN, urinalysis)

    Monthly

Secondary Outcomes (1)

  • Percentage of systemic T regulatory population

    Every 3 months

Study Arms (1)

1

EXPERIMENTAL
Biological: Allogeneic MSC (AlloMSC)

Interventions

Allogeneic MSC (AlloMSC)BIOLOGICAL

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

1

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18389442BACKGROUND

  • 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.

    PMID: 18061155BACKGROUND

  • 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.

    PMID: 17402368BACKGROUND

  • 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.

    PMID: 30428931DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicLupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Lingyun Sun, M.D.

    Nanjing University Medical College Affiliated Drum Tower Hospital

    STUDY DIRECTOR

Central Study Contacts

Sun Lingyun, MD

CONTACT

+86 25 83105219lingyunsun2001@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 17, 2008

Study Start

March 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

CN(1)