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Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

ConditionsLupus NephritisLupus Erythematosus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRed de Terapia Celular

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesenchymal stem cells (MSC)

    Drug

    Endovenous injection of MSV in saline solution

  • Placebo

    Drug

    Endovenous injection of saline solution without cells

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Mesenchymal stem cells (MSC)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
0-24 weeks
2

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.

Time frame
0-24 weeks

Secondary outcomes

1

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

The corticosteroid reduction is defined as reduction by ≥ 25% in comparison with the selection visit and to a dose ≤ 7.5 mg/day and who have no exacerbation BILAG A or 2B. A BILAG A or 2B exacerbation is defined as at least one new BILAG A organic domain score or at least 2 new BILAG B organic domain scores compared to the selection visit.

Time frame
0-24 weeks
2

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

The corticosteroid reduction is defined as reduction by ≥ 25% in comparison with the selection visit and at a dose ≤ 7.5 mg/day, and who do not have any BILAG A or 2B exacerbations of disease activity.

Time frame
Throughout the study until its completion, an average of 1.5 years
3

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

Different levels of corticosteroid dose reduction: 0-\<25%, 25%-50%, \>50%.

Time frame
0-24 weeks
4

Cumulative dose of corticosteroids

Cumulative dose of corticosteroids equivalent to prednisone up to week 24

Time frame
0-24 weeks

Other outcomes

Sponsors and contacts

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Red de Terapia Celular

Lead sponsor

Hospital del Rio Hortega

Collaborator

Hospital Clínico Universitario de Valladolid

Collaborator

University of Valladolid

Collaborator

Citospin

Collaborator

Source ClinicalTrials.gov
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