Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis. The objective of this study is to evaluate the efficacy of mesenchymal stem cells (MSCs) in achieving a full response in the treatment of Lupus Nephritis (LN) during its induction period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Red de Terapia Celular
• Collaborators: Hospital Clínico Universitario de Valladolid; Hospital del Río Hortega; University of Valladolid

Criteria

Inclusion Criteria:

• Male or female ≥ 18 yrs with written informed consent.

• SLE diagnosis fulfilling at least 4 out of the 11 ACR criteria during the course of their illness.

• Diagnosis of LN class (2003 classification by International Society of Nephrology/Renal Pathology Society) by biopsy less than 6 months prior.

• No response or partial response to induction therapy, according the recommendations of EULAR/ERA-EDTA and ACR with corticoids plus or not cyclophosphamide (500-1.000 mg/m² body surface/m²) or mycophenolate mofetil (2-2.5 gr/day) or mycophenolate sodium (1.040-1.800 mg/day), after at least three months.

• SLEDAI-2K score ≥ 6 at selection period.

• Women subjects of childbearing potential must use a highly effective method of contraception to prevent pregnancy.

• History of vaccinations against S. pneumococcus, H. influenza and seasonal vaccinations, as required.

Exclusion Criteria:

• Use of corticoids, mycophenolate, cyclophosphamide above doses permitted for induction, according to the EULAR/ERA-EDTA and ACR.

• Use of rituximab, belimumab or ocrelizumab, or other B cell-directed biologic therapies within 1 yr before treatment.

• Use of abatacept within 1 yr before treatment.

• Use of any tumor necrosis factor (TNF) inhibitor therapy within 1 yr before selection.

• Use of immunoglobulin treatment within 1 yr before treatment.

• Change in dosage of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) within 2 months before treatment.

• Treatment with other investigational agents within the last 3 months or 5 half-lives prior to treatment.

• Any condition that in the investigator´s opinion constitutes an unnecessary risk or a counterindication for participation.

• History of or planned renal or other organ transplant.

• Positive human immunodeficiency virus or hepatitis C Ab and/or PCR, or hepatitis B surface antigen (+), or hepatitis B cIgG and/or IgM Ab(+) with (-) hepatitis B sAb.

• Diagnosis of active tuberculosis, or latent tuberculosis infection.

• History of cancer.

• History of major surgery within 6 months prior to treatment.

• Lactating women.

• Legal incapacity or limited legal capacity.