NCT00659217

Brief Summary

Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Manifestations of systemic lupus eryhematosus(SLE) may in most patients be ameliorated with medications that suppress the immune system. Nevertheless, there remains a subset of SLE patients for whom current strategies are insufficient to control disease. The investigators will infuse expanded autologous MSC into patients with lupus Nephritis. The purpose of this trial is to evaluate whether this new therapeutical approach will result in improvement in the lupus disease.

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 May 2008

Typical duration 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

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 16, 2008

Status Verified

April 1, 2008

Enrollment Period

2 years

First QC Date

April 14, 2008

Last Update Submit

April 14, 2008

Conditions

Lupus Nephritis

Keywords

Mesenchymal Stem Cellslupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • the proportion of participants who achieve and maintain remission

    5

Secondary Outcomes (5)

  • Patient survival

    5

  • Creatinine and proteinuria.

    5

  • SLE disease activity index

    5

  • Serology (ANA, dsDNA)

    5

  • ComplementC3 and C4

    5

Study Arms (1)

2

EXPERIMENTAL

mesenchymal stem cell Autologous MSC transplantation

Biological: mesenchymal stem cell

Interventions

mesenchymal stem cellBIOLOGICAL

Autologous MSC transplantation

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18 to 50 years old.
  • Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteria for SLE.
  • Able to give informed consent.
  • For treatment -refractory lupus nephritis, participants must fail pulse cyclophosphamide, a renal biopsy must be obtained and document either class III or IV glomerulonephritis.

You may not qualify if:

  • Pregnant women.
  • Previous history of malignancy
  • Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
  • Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
  • Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
  • Transaminases greater than 2 times normal unless due to active lupus.
  • Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jianming Tan, Professor JM Tan, doctor

CONTACT

008613375918000doctortjm@YAHOO.COM

Study Design

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

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 16, 2008

Record last verified: 2008-04

Locations

CN(1)