Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis
NCT ID: NCT03458156
Last Updated: 2018-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-01-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLE group
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
SLE group
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
LN group
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
LN group
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
the control group
The patients will be assigned to the control group.
the control group
The patients will be assigned to the control group.
Interventions
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SLE group
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
LN group
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
the control group
The patients will be assigned to the control group.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
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Liu Jing
Chief Physician
Principal Investigators
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Liu Jing, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Other Identifiers
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DalianMU_JL_002
Identifier Type: -
Identifier Source: org_study_id
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