NCT03458156

Brief Summary

To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

February 7, 2018

Last Update Submit

March 8, 2018

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • SLEDAI-2000 score

    The SLEDAI 2000 is a novel index that measures ≥ 50% in each of the 24 descriptors of SLEDAI-2K and generates a total score reflecting disease activity overall.

    changes of month 3, month 6, month 9 and month 12 after treatment

Secondary Outcomes (2)

  • BILAG-2004 score

    changes of month 3, month 6, month 9 and month 12 after treatment

  • Health Assessment Questionnaire (HAQ) score

    changes of month 3, month 6, month 9 and month 12 after treatment

Study Arms (3)

SLE group

EXPERIMENTAL

The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.

Biological: SLE group

LN group

EXPERIMENTAL

The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.

Biological: LN group

the control group

EXPERIMENTAL

The patients will be assigned to the control group.

Other: the control group

Interventions

SLE groupBIOLOGICAL

The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.

SLE group
LN groupBIOLOGICAL

The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.

LN group
the control groupOTHER

The patients will be assigned to the control group.

the control group

Eligibility Criteria

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

You may qualify if:

  • Meeting the 1997 American College of Rheumatology (ACR) classification criteria of SLE.
  • age 18-60 years.
  • of either sex and of any ethnicity.
  • Lupus nephritis (LN) group: (1) Receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dL; (2) renal biopsy: class III, IV or V LN included, and class VI excluded.
  • After conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, SLEDAI scores ≥ 10.
  • Receiving 12 months of treatment while using birth control.
  • Provision of informed consent.

You may not qualify if:

  • Poor blood pressure control by drug treatment (≥ 160/100 mmHg)
  • Abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver).
  • Renal failure (glomerular filtration rate \< 15 mL/min/1.73 m2).
  • Severe heart and lung failure, or injury to other important organs
  • Uncontrollable infection.
  • Having not taken biological agents for 6 months.
  • Pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Officials

  • Liu Jing, Ph.D

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 8, 2018

Study Start

January 1, 2017

Primary Completion

September 1, 2019

Study Completion

January 1, 2020

Last Updated

March 12, 2018

Record last verified: 2018-03