Clinical trial NCT04318600: Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis
Official title: Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Nephritis
Mesenchymal Stem Cells
Keywords: Lupus Nephritis
Human Amniotic Mesenchymal Stem Cell
cell therapy
clinical trail
Lead sponsor: Yan'an Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Yunnan
First posted: 2020-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 60 weeks
Secondary outcomes:
measure: Changes in 24h urine protein quantification before and after treatment；
timeFrame: 60 weeks
measure: Changes in eGFR before and after treatment;
timeFrame: 60 weeks
measure: Changes in SLEDAI score before and after treatment；
timeFrame: 60 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Naeem A, Gupta N, Naeem U, Khan MJ, Elrayess MA, Cui W, Albanese C. A comparison of isolation and culture protocols for human amniotic mesenchymal stem cells. Cell Cycle. 2022 Aug;21(15):1543-1556. doi: 10.1080/15384101.2022.2060641. Epub 2022 Apr 12.