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Lupus NephritisPhase 2MSV_LENCT03673748

Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

A Phase 2 study testing Mesenchymal stem cells (MSC) in people with Lupus Nephritis and Lupus Erythematosus, run by Red de Terapia Celular at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Nephritis, Lupus Erythematosus
What is being tested?
Mesenchymal stem cells (MSC)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteSpain
Study dates
27 Dec 2022to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.
  • Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease.
  • Antecedents or plans for an organ transplant.
  • Clinically significant active viral, bacterial or fungal infection, or having suffered a major episode of infection that required hospitalization or parenteral treatment in the 4 weeks prior to the selection visit, during the selection visit, or having finished anti-infective treatment within 2 weeks prior to or during selection, or a history of recurrent infections (three or more cases of the same type of infection in a consecutive 12-month period). Controlled vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus would not be reasons for exclusion.
  • History of or positive human immunodeficiency virus (HIV) test result, hepatitis C antibodies and/or detection by polymerase chain reaction, hepatitis B surface antigen (HBsAg+), and/or IgM or total antibodies against hepatitis B nuclear antigen at selection.
  • Diagnosis of active or latent tuberculosis (TB) using a purified protein derivative TB skin test (induration ≥ 5 mm) or a positive Quantiferon test result, at selection or within 3 months prior to the selection visit. Patients who have completed previous adequate treatment or who are receiving treatment will not repeat the test. Patients who are receiving adequate TB treatment for at least 4 continuous weeks prior to the selection visit and who are expected to complete the treatment regimen will not be excluded.
  • Presence of class 3 or 4 uncontrolled congestive heart failure according to the New York Heart Association.
  • Active cancer.
  • Major surgical intervention within 6 weeks prior to selection visit or planned during the trial period, including follow-up.
  • Pregnant or lactating women.
  • C - Laboratory abnormalities:
  • Clinically significant laboratory test abnormalities not attributed to active SLE.
  • Chest X-ray with significant changes indicating active TB. The chest X-ray must have been performed within 3 months prior to the selection visit or during the selection period.
  • D - Others:
  • Legal incapacity.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julia Barbado, MD, PhD contact

+34 983 420400

jbarbadoa@saludcastillayleon.es

Margarita González-Vallinas, PhD contact

+34 983 184688

mgvallinas@ibgm.uva.es

Spain1 site, 1 recruiting

  • University Hospital Río Hortega

    Valladolid, Valladolid, 47012

    Julia Barbado, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Phase II, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate Safety and Efficacy of Mesenchymal Stem Cells (MSV-allo) in the Treatment of Lupus Nephritis

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.

Read the detailed description

A Phase 2b, double-blind (neither the participant nor the investigator will know if active drug or placebo is assigned), placebo-controlled, randomized (assigned by chance), in which subjects with Lupus Nephritis (LN), who do not respond -or respond partially- to induction treatment, shall receive either MSCs (2 million cells/Kg) or placebo by intravenous injection. The administration of cells will be done only once.

Being tested
Mesenchymal stem cells (MSC), Placebo
Keywords
Lupus Erythematosus, Lupus Nephritis, Stem Cell, Mesenchymal Stem Cells, Autoimmune diseases, Systemic Lupus Erythematosus
Medical subject headings
Lupus Nephritis, Autoimmune Diseases, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal stem cells (MSC)Drug

    Also called MSV, GMP-compliant MSC manufactured by IBGM in Valladolid

    Endovenous injection of MSV in saline solution

  • PlaceboDrug

    Also called Saline solution

    Endovenous injection of saline solution without cells

Study groups in NCT03673748
Study groupRoleWhat they receive
Mesenchymal stem cells (MSC)ExperimentalParticipants 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.
Receives: Drug: Mesenchymal stem cells (MSC)
PlaceboPlacebo comparatorParticipants will receive a placebo infusion (100 ml of physiological saline solution) that does not contain any mesenchymal stem cells.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 0-24 weeks

Secondary outcomes (9)

  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.

    Measured: 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.

    Measured: 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%.

    Measured: 0-24 weeks

  4. Cumulative dose of corticosteroids

    Cumulative dose of corticosteroids equivalent to prednisone up to week 24

    Measured: 0-24 weeks

  5. Proportion of patients who have reduced the dose of immunosuppressants

    Proportion of patients who, up to week 24, have reduced the dose of immunosuppressants without presenting any BILAG A or 2B exacerbation.

    Measured: 0-24 weeks

  6. Change from baseline in SF-36 score

    Quality of life questionnaire (SF-36)

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

  7. Change from baseline in LupusQoL score

    Quality of life questionnaire specific for LES (LupusQoL)

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

  8. Change in proteinuria levels

    Change from baseline in the levels of proteinuria, a sign of disease activity

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

  9. Change in disease activity (SLEDAI-2K index)

    Change in disease activity measured by change from baseline of Systemic Lupus Erythematosus Disease Activity (SLEDAI-2K) index, which computes the score of different parameters.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start27 Dec 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control arm (placebo) and experimental arm (mesenchymal stem cells)
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673748
Sponsor's protocol ID
TerCel_006
Other IDs
2022-000243-80
Acronym
MSV_LE
Status last verified
Aug 2026
First submitted
12 Sep 2018
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25822648

  • 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.

    PubMed 27661661

  • 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.

    PubMed 30290717

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal stem cells (MSC) in people with Lupus Nephritis and Lupus Erythematosus, run by Red de Terapia Celular at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julia Barbado, MD, PhD (+34 983 420400, jbarbadoa@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who have achieved complete response (time frame: 0-24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03673748, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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