Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis

NCT ID: NCT04318600

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2019-01-01

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.

Conditions

Lupus Nephritis; Mesenchymal Stem Cells

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

human amniotic mesenchymal stem cell treatment group

Group Type: EXPERIMENTAL

human amniotic mesenchymal stem cell

Intervention Type: DRUG

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).

blank control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Yunnan

OTHER

Sponsor Role: collaborator

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 35412950 (View on PubMed)

Other Identifiers

2014001

Identifier Type: -

Identifier Source: org_study_id