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Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells (MSV_LE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03673748
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : March 12, 2020
Hospital del Río Hortega
Hospital Clínico Universitario de Valladolid
University of Valladolid
Information provided by (Responsible Party):
Red de Terapia Celular

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

Condition or disease Intervention/treatment Phase
Lupus Nephritis Lupus Erythematosus Drug: Mesenchymal stromal cells (MSC) Drug: Placebo Phase 2

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 (1.5 million cells/Kg) or placebo by intravenous injection. The administration of cells will be done only once. Eligible patients should have been receiving induction treatment for at least three months but no more than six.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control arm (placebo) and experimental arm (mesenchymal stromal cells)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Both experimental and Control will receive a similar endovenous injection with either cells or placebo. Blind to participant, investigator ans care providers,
Primary Purpose: Treatment
Official Title: A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Lupus Nephritis
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mesenchymal stromal cells (MSC)
Participants will receive a single Intravenous infusion of Mesenchymal Stem Cells (MSV) 1.5 million cells per kg wt suspended in isotonic medium (Physiological saline solution + 1% Human Albumin + 5 mM Glucose). 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
Drug: Mesenchymal stromal cells (MSC)
Endovenous injection of MSV in saline
Other Name: MSV, GMP-compliant MSC manufactured by IBGM in Valladolid

Placebo Comparator: Placebo
Participants will receive a placebo infusion that does not contain any mesenchymal stem cells. The placebo infusion will consist of physiological saline solution + 1% Human Albumin + 5 mM Glucose, which is the same vehicle used to deliver the MSCs in the experimental groups.
Drug: Placebo
Endovenous injection of saline without cells
Other Name: Saline

Primary Outcome Measures :
  1. Frequency of severe adverse events [ Time Frame: 0-52 weeks ]
    Frequency of grade 3 or higher adverse events (SAEs) at or prior to Week 52

  2. Evolution of Complete Renal Response defined as decrease of urine protein:creatinine ratio (UPCR; Normal value<50mg/mmol) [ Time Frame: 0-52 weeks ]
    Evaluates the efficacy of mesenchymal stem cells (MSCs) in achieving full or partial response of proliferative Lupus. The UPCR normal value is <50mg/mmol (roughly equivalent to proteinuria <0.5g/24h). Partial renal response, defined as ≥50% reduction in proteinuria should be achieved preferably by 6 months and no later than 12 months following treatment initiation.

Secondary Outcome Measures :
  1. Change in disease activity measured by change of Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) [ Time Frame: 0-52 wk ]
    SLEDAI measures activity by computing the score of 24 parameters. Range: 0 to 105.

  2. Change in prednisone dose measured as percent of the baseline value [ Time Frame: 0-52 wk ]
    Decrease of activity permits to decrease medication. Units are percent value of baseline.

  3. Cellular markers of inflammation and autoimmunity [ Time Frame: 0-52 wk ]
    Lymphocyte profiles, CD3, CD19, CD16+CD56,CD4/CD8, Tregs

  4. Serum markers of inflammation and autoimmunity [ Time Frame: 0-52 wk ]
    Anti-DNA antibodies, complement

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03673748

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Contact: Julia Barbado, MD, PhD +34 983 420400
Contact: Javier Garcia-Sancho, MD, PhD +34 983 184827

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University Hospital Río Hortega
Valladolid, Spain, 47012
Contact: Julia Barbado, MD, PhD         
Sponsors and Collaborators
Red de Terapia Celular
Hospital del Río Hortega
Hospital Clínico Universitario de Valladolid
University of Valladolid
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Study Chair: Julia Barbado, MD, PhD University Hospital Río Hortega, Valladolid, Spain,
Additional Information:
SLE  This link exits the site
Lupus  This link exits the site

Publications of Results:
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Responsible Party: Red de Terapia Celular Identifier: NCT03673748    
Other Study ID Numbers: TerCel_006
2017-000391-28 ( EudraCT Number )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Red de Terapia Celular:
Lupus Erythematosus
Lupus Nephritis
Stem Cell
Mesenchymal Stem Cells
Autoimmune diseases
Systemic Lupus Erythematosus
Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases