An interventional study of SLE group and LN group in Lupus Nephritis, sponsored by The First Affiliated Hospital of Dalian Medical University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Not applicable, Interventional, and Treatment
To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).
Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. Lupus nephritis (LN) is one of the most serious complications of SLE. The current clinical treatments of LN mainly include steroids and immunosuppressive drugs, but drug side effects are obvious.
Exclusion Criteria:
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
Biological: SLE group
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
Biological: LN group
The patients will be assigned to the control group.
Other: the control group
The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
The patients will be assigned to the control group.
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.
Time frame: changes of month 3, month 6, month 9 and month 12 after treatment
BILAG-2004 score
The BILAG-2004 is a comprehensive composite clinical index that has been recently validated for the assessment of systemic lupus erythematosus (SLE) disease activity. This index is based on the Classic BILAG index and has many similarities with its predecessor: it is based on the principle of the physician's intention to treat, has transitional property that captures changing severity of clinical manifestations and has a similar ordinal scale scoring system. However, it has nine systems and many of the changes (from the Classic BILAG index) are in the items, glossary and scoring scheme. As with the Classic BILAG index, the individual system scores were not intended to be summated into a global score.
Time frame: changes of month 3, month 6, month 9 and month 12 after treatment
Health Assessment Questionnaire (HAQ) score
The Health Assessment Questionnaire (HAQ) has played an influential role in establishing health outcome assessment as a quantifiable set of reliable, valid and responsive hard data points. The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality. It has been validated by mail, in the office, by telephone, and by comparison with paraprofessional and physician judgments as a reliable instrument, and has been significantly correlated with other PRO instruments. Typically, one of two HAQ versions is used: the Full HAQ, which assesses all five dimensions, and the Short or 2-page HAQ, which contains only the HAQ disability index (HAQ-DI) and the HAQ's patient global and pain visual analog scales (VAS).
Time frame: changes of month 3, month 6, month 9 and month 12 after treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Dalian Medical University