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
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis Lupus Erythematosus||Drug: Mesenchymal stromal cells (MSC) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|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,|
|Official Title:||A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Lupus Nephritis|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
Endovenous injection of saline without cells
Other Name: Saline
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03673748
|Contact: Julia Barbado, MD, PhD||+34 983 firstname.lastname@example.org|
|Contact: Javier Garcia-Sancho, MD, PhD||+34 983 email@example.com|
|University Hospital Río Hortega||Not yet recruiting|
|Valladolid, Spain, 47012|
|Contact: Julia Barbado, MD, PhD|
|Study Chair:||Julia Barbado, MD, PhD||University Hospital Río Hortega, Valladolid, Spain,|