Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis

Phase 1

Completed

• Conditions: Lupus Nephritis; Mesenchymal Stem Cells
• Interventions: Drug: human amniotic mesenchymal stem cell

• Registration Number: NCT04318600
• Lead Sponsor: Yan'an Affiliated Hospital of Kunming Medical University

Brief Summary

This study would further evaluate the safety and efficacy of human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis (LN).

Detailed Description

Eleven patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times). At the same time, five patients with LN who were not given hA-MSC as the blank control group. All patients did not received intravenous corticosteroids pulse therapy, but the use of oral corticosteroids and intravenous cyclophosphamide, or oral mycophenolate mofetil, tacrolimus , leflunomide were allowed.

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01-01
• Primary Completion: 2017-03-01
• Study Completion: 2019-01-01
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-20
• Last Update Submitted: 2020-03-20
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
human amniotic mesenchymal stem cell treatment group	human amniotic mesenchymal stem cell	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	60 weeks	The patient's discomfort and clinical symptoms during the study were recorded, as well as the related laboratory test indicators and physical examination abnormalities of the subjects during the study. Describe the association with Amniotic mesenchymal stem cell therapy and calculate the incidence of treatment-related acute and chronic adverse events.

Secondary Outcome Measures

Name	Time	Method
Changes in 24h urine protein quantification before and after treatment；	60 weeks	24-hour urinary protein quantification from baseline to 60 weeks of treatment.
Changes in eGFR before and after treatment;	60 weeks	changes in estimated glomerular filtration rate (eGFR) from baseline to 60 weeks of treatment.
Changes in SLEDAI score before and after treatment；	60 weeks	changes in SLEDAI score from baseline to 60 weeks of treatment. SLEDAI score: 0\~4 points basically no activity;5-9 minutes light activity;10-14 minutes of moderate activity;≥15 minutes of severe activity.