Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

NCT03673748 | Recruiting Phase 2 DMC

• 2 other identifiers: TerCel_0062022-000243-80
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 or partial response in the treatment of Lupus Nephritis (LN) during its induction period.

Conditions

Lupus Nephritis; Lupus Erythematosus

Keywords

Lupus Erythematosus; Lupus Nephritis; Stem Cell; Mesenchymal Stem Cells; Autoimmune diseases; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who have achieved complete response

  Complete renal response criteria: glomerular filtration rate ≥ 60ml/min/1.73m², or decrease to initial values or ± 15% of the baseline value in those with glomerular filtration rate \< 60ml/min/1.73m²; proteinuria ≤ 0.5 g/24h; inactive sediment: ≤ 5 red blood cells, ≤ 5 leukocytes, absence of red blood cell casts; and serum albumin \> 3 g/dl.

  0-24 weeks

• Proportion of patients who have achieved partial response

  Partial renal response criteria: if baseline proteinuria ≥ 3.5 g/24h, decrease in proteinuria \< 3.5 g/24h; if baseline proteinuria \< 3.5 g/24h, proteinuria reduced by \> 50% compared to baseline; in both situations stabilization (±25%) or improvement in glomerular filtration compared to baseline values.

  0-24 weeks

Secondary Outcomes (9)

• Proportion of patients at week 24 whose prednisone-equivalent corticosteroid dose has been reduced

  0-24 weeks

• Proportion of patients at each visit whose prednisone-equivalent corticosteroid dose has been reduced

  Throughout the study until its completion, an average of 1.5 years

• Proportion of patients at week 24 with a specific reduction relative to the selection visit in the daily dose of prednisone-equivalent corticosteroids.

  0-24 weeks

• Cumulative dose of corticosteroids

  0-24 weeks

• Proportion of patients who have reduced the dose of immunosuppressants

  0-24 weeks

Study Arms (2)

Mesenchymal stem cells (MSC)

EXPERIMENTAL

Participants will receive a single Intravenous infusion of Mesenchymal Stem Cells (MSV) 2 million cells per kg wt suspended in 100 ml of physiological saline solution. All participants will receive the infusion at the Baseline (Day 0) visit. All participants will continue on their standard-of-care therapy during the trial. GMP-compliant MSV will be prepared by IBGM-University of Valladolid-Citospin.

Drug: Mesenchymal stem cells (MSC)

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo infusion (100 ml of physiological saline solution) that does not contain any mesenchymal stem cells.

Drug: Placebo

Interventions

Mesenchymal stem cells (MSC) DRUG

Endovenous injection of MSV in saline solution

Also known as: MSV, GMP-compliant MSC manufactured by IBGM in Valladolid

Mesenchymal stem cells (MSC)

Placebo DRUG

Endovenous injection of saline solution without cells

Also known as: Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or males ≥18 years old who provide written informed consent at the selection visit.
• Diagnosis of systemic lupus erythematosus (SLE) by meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) classification and/or the Systemic Lupus International Collaborating Clinics (SLICC) criteria, at the selection visit.
• Diagnosis of lupus nephritis (LN) using the 2003 classification of the International Society of Nephrology and the Society of Renal Pathology, by biopsy performed no more than 6 months before the selection visit if they enter from the induction period, and no more than one year if they enter with a moderate/severe recurrence.
• No response or partial response to standard treatment, or moderate/severe recurrence of lupus nephritis.
• SLEDAI-2K ≥ 10 during the selection period.
• Women of childbearing potential should use effective methods of contraception to prevent pregnancy.
• Have been vaccinated against pneumococcus and influenza at the time the vaccination campaign is carried out.

You may not qualify if:

• A - Related to previous treatments:
• Use of corticosteroids or mycophenolate above the doses allowed for induction, according to the Consensus Document of the Systemic Autoimmune Diseases Group of the Spanish Society of Internal Medicine and the Spanish Society of Nephrology.
• Use of rituximab, belimumab, ocrelizumab or other biologic therapies against B cells in the 6 months prior to selection.
• Use of cyclophosphamide in the 6 months prior to selection.
• Use of any tumor necrosis factor inhibitor treatment in the 6 months prior to selection.
• Use of immunoglobulins in the 6 months prior to selection.
• Change in doses of an angiotensin converting enzyme inhibitor or an angiotensin receptor inhibitor in the two months prior to selection.
• Treatment with another investigational medicinal product within three months prior to selection or 5 times the half-life of the agent.
• B - Related to medical problems:
• Any pathology, including an uncontrolled disease other than SLE, which, in the opinion of the investigator, the sponsor or the person they designate, constitutes an inappropriate risk or a contraindication for participation in the trial or that could interfere with the objectives of the trial, its performance or evaluation.
• Cardiac, peripheral, or cerebrovascular cardiovascular events in the 6 months prior to the selection visit.
• Active cardiac arrhythmia or clinically significant electrocardiogram abnormalities at selection visit or on the day of randomization that, in the opinion of the investigator, sponsor, or designee, constitute an inappropriate risk or contraindication to participation in the study.
• Thromboembolic events in the 12 months prior to or during selection, whether or not associated with associated antiphospholipid syndrome, or inadequate anticoagulation tests 6 weeks immediately prior to or during selection visit.
• Active central nervous system SLE that is considered severe or progressive (recent uncontrolled seizures, changes in anticonvulsant treatment within 3 months prior to selection visit, or resulting in significant cognitive impairment).
• History or current diagnosis of a demyelinating disease such as multiple sclerosis or optic neuritis.

Sponsors & Collaborators

• Red de Terapia Celular: lead
• Hospital del Rio Hortega: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator
• University of Valladolid: collaborator
• Citospin: collaborator

Study Sites (1)

University Hospital Río Hortega

Valladolid, Valladolid, 47012, Spain

RECRUITING

Related Publications (3)

• Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.

  PMID: 25822648 BACKGROUND

• Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Sanchez A, Garcia-Sancho J. Intervertebral Disc Repair by Allogeneic Mesenchymal Bone Marrow Cells: A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1945-1951. doi: 10.1097/TP.0000000000001484.

  PMID: 27661661 BACKGROUND

• Barbado J, Tabera S, Sanchez A, Garcia-Sancho J. Therapeutic potential of allogeneic mesenchymal stromal cells transplantation for lupus nephritis. Lupus. 2018 Nov;27(13):2161-2165. doi: 10.1177/0961203318804922. Epub 2018 Oct 5.

  PMID: 30290717 BACKGROUND

Related Links

• SLE
• Lupus

MeSH Terms

Conditions

Lupus Nephritis; Autoimmune Diseases; Lupus Erythematosus, Systemic

Interventions

Genes, mos; Saline Solution

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogenes; Oncogenes; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Julia Barbado, MD, PhD

  University Hospital Río Hortega, Valladolid, Spain

  STUDY CHAIR

• Rosa Conde, PhD

  University Hospital Río Hortega, Valladolid, Spain

  STUDY DIRECTOR

• Margarita González-Vallinas, PhD

  University of Valladolid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Barbado, MD, PhD

CONTACT

+34 983 420400; jbarbadoa@saludcastillayleon.es

Margarita González-Vallinas, PhD

CONTACT

+34 983 184688; mgvallinas@ibgm.uva.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both Experimental and Control arms will receive a similar endovenous injection with either cells or placebo. Blind to participant, investigator and care providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Control arm (placebo) and experimental arm (mesenchymal stem cells)

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: December 27, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

ES (1)