Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318600
• Other study ID #: 2014001
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2014
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2014
• Source: Yan'an Affiliated Hospital of Kunming Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 1, 2019
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

Enrollment criteria:

• Adult patients (age 14-60 years) who were diagnosed as lupus nephritis, regardless of gender, uncontrolled disease course;

• Pathological examination of puncture biopsy resulting in diagnosis of type II, III, or IV lupus nephritis;

• SLEDAI score >8;

• proteinuria greater than 1 g/day and active urinary sediments;

• Lupus nephritis treatment according to guidelines and norms before human amniotic mesenchymal stem cells therapy;

• If there is a possibility of pregnancy in female, must be negative pregnancy test, not in lactation, and confirm that is receiving the method of contraception recognized by the researchers, and agree to maintain the method of contraception throughout the study. Sexually active male patients must agree to the use of an appropriate contraceptive method for birth control from the first administration of the study treatment until 24 weeks after the last administration.

• The subjects should be fully informed, voluntarily sign the informed consent, and agree to participate in all visits, examinations, and treatments as required by the experimental protocol.

Exclusion criteria:

• Patients with kidney biopsy diagnosis of type I, VI lupus nephritis or a diagnosis of another glomerular disease;

• Patients with abnormal renal function (serum creatinine = the upper limit of normal);

• Patients with active liver disease or abnormal liver function test results (ALT or AST =2 times the upper limit of normal);

• Patients with blood leukocyte count <2.5 × 109/L, hemoglobin <90 g/L, platelet count <100 × 109/L, or those who have other hematologic diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, coagulation dysfunction, etc.);

• Patients with serious and unstable cardiovascular or cerebrovascular diseases (unstable angina pectoris, coronary artery disease, cerebrovascular disease, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control the disease, after treatment has not been effectively controlled severe hypertension (blood pressure >160/100 mm Hg), or organ transplantation;

• Patients with uncontrolled infection;

• Patients with tumors or abnormal tumor marker levels; 8. Patients with blood-borne diseases (i.e., HIV, syphilis, hepatitis B, and hepatitis C);

• Pregnancy, the potential for pregnancy, or lactation;

• Patients with a history of allergy, especially patients allergic to human blood albumin;

• Patients with mental illness affecting their voluntarism, ability to make decisions, and ability to communicate;

• A history of alcoholism or known drug addiction in the last 2 years;

• Participation in another clinical trial within the last 3 months;

• Patients judged inappropriate for this study by the physicians.

Related Conditions & MeSH terms

• Lupus Nephritis
• Mesenchymal Stem Cells
• Nephritis

Intervention

Drug:
• human amniotic mesenchymal stem cell
human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yan'an Affiliated Hospital of Kunming Medical University	The First People's Hospital of Yunnan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	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.	60 weeks
Secondary	Changes in 24h urine protein quantification before and after treatment;	24-hour urinary protein quantification from baseline to 60 weeks of treatment.	60 weeks
Secondary	Changes in eGFR before and after treatment;	changes in estimated glomerular filtration rate (eGFR) from baseline to 60 weeks of treatment.	60 weeks
Secondary	Changes in SLEDAI score before and after treatment;	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.	60 weeks