Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis

NCT04318600 | Completed Phase 1

• 1 other identifier: 2014001
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Lupus Nephritis; Mesenchymal Stem Cells

Keywords

Lupus Nephritis; Human Amniotic Mesenchymal Stem Cell; cell therapy; clinical trail

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in 24h urine protein quantification before and after treatment；

  60 weeks

• Changes in eGFR before and after treatment;

  60 weeks

• Changes in SLEDAI score before and after treatment；

  60 weeks

Study Arms (2)

human amniotic mesenchymal stem cell treatment group

EXPERIMENTAL

Drug: human amniotic mesenchymal stem cell

blank control group

NO INTERVENTION

Interventions

human amniotic mesenchymal stem cell 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).

human amniotic mesenchymal stem cell treatment group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead
• The First People's Hospital of Yunnan: collaborator

Related Publications (1)

• 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.

  PMID: 35412950 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 24, 2020
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: January 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2014-01