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

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ClinicalTrials.gov Identifier: NCT03673748
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Hospital del Río Hortega
Hospital Clínico Universitario de Valladolid
University of Valladolid
Information provided by (Responsible Party):
Red de Terapia Celular

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date September 17, 2018
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
  • 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.
  • 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.
  • Cellular markers of inflammation and autoimmunity [ Time Frame: 0-52 wk ]
    Lymphocyte profiles, CD3, CD19, CD16+CD56,CD4/CD8, Tregs
  • Serum markers of inflammation and autoimmunity [ Time Frame: 0-52 wk ]
    Anti-DNA antibodies, complement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells
Official Title  ICMJE A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Lupus Nephritis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Lupus Nephritis
  • Lupus Erythematosus
Intervention  ICMJE
  • Drug: Mesenchymal stromal cells (MSC)
    Endovenous injection of MSV in saline
    Other Name: MSV, GMP-compliant MSC manufactured by IBGM in Valladolid
  • Drug: Placebo
    Endovenous injection of saline without cells
    Other Name: Saline
Study Arms  ICMJE
  • 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
    Intervention: Drug: Mesenchymal stromal cells (MSC)
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julia Barbado, MD, PhD +34 983 420400 jbarbadoa@saludcastillayleon.es
Contact: Javier Garcia-Sancho, MD, PhD +34 983 184827 jgsancho@ibgm.uva.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03673748
Other Study ID Numbers  ICMJE TerCel_006
2017-000391-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Red de Terapia Celular
Study Sponsor  ICMJE Red de Terapia Celular
Collaborators  ICMJE
  • Hospital del Río Hortega
  • Hospital Clínico Universitario de Valladolid
  • University of Valladolid
Investigators  ICMJE
Study Chair: Julia Barbado, MD, PhD University Hospital Río Hortega, Valladolid, Spain,
PRS Account Red de Terapia Celular
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP