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Effect of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cell Transplantation on SLE

Phase 1
Conditions
Severe and Refractory Lupus Nephritis.
Systemic lupus erythematosus with organ or system involvement
Registration Number
IRCT2016090729747N1
Lead Sponsor
Council for Stem Cell Sciences and Technologies
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Criteria for entrance to the study: Criteria for entrance to the study include increase in proteinuria (defined as more than 1.0 g of protein excretion in a 24-h urine specimen), Systemic lupus erythematosus disease activity index of more than 8 (All patients were resistant to at least 3 months of therapy with conventional treatment standard).
Exclusion criteria:
uncontrolled infection, failure of kidney or other vital organs, pregnancy or lactating.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proteinuria. Timepoint: 1 week, 1, 3, 6, 9 and 12 months. Method of measurement: clinical tests.;Glomerular filtration rate. Timepoint: 1 week, 1, 3, 6, 9 and 12 months. Method of measurement: clinical tests.
Secondary Outcome Measures
NameTimeMethod
Systemic lupus erythematosus disease activity index score. Timepoint: 1 week, 1, 3, 6, 12 and 18 months. Method of measurement: clinical tests.
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