A PHASE II, DOUBLE-BLIND, CONTROLLED, PARALLEL-ARM TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A SINGLE INFUSION OF ALLOGENIC MESENCHYMAL STEM CELLS IN LUPUS NEPHRITIS (LN)

Phase 1

• Conditions: PUS NEPHRITIS; MedDRA version: 20.0Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-000391-28-ES
• Lead Sponsor: INSTITUTO DE ESTUDIOS DE CIENCIAS DE LA SALUD DE CASTILLA Y LEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-29
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female = 18 yrs with written informed consent.
2.SLE diagnosis fulfiilling at least 4 out of the 11 ACR criteria during the course of their illness.
3.Diagnosis of LN class (2003 classification by International Society of Nephrology/Renal Pathology Society) by biopsy less than 6 months prior.
4.No response or partial response to induction therapy after at least three months with cyclophosphamide (750 mg/m² body surface/mo) or mycophenolat mofetil (2-2.5 gr/day) or mycophenolate sodium (1.040-1.800 mg/day) plus corticoids = 40 mg per day. Complete response criteria is: glomerular filtration rate = 60 ml/min/1,73m², or decline to baseline or ± 15% of baseline in those with glomerular filtration rate < 60 ml/min/1,73m², proteinuria = 0.5 g in 24 h, inactive sediment (= 5 erythrocytes, = 5 lymphocytes or cell casts) and serum albumin > 3gr/d. Partial response means patients with basal proteinuria = 3.5 g in 24 h that declines < 3.5 grams in 24 h; patients with basal proteinuria < 3.5 g in 24 h that declines > 50%; stabilization or improvement of glomerular filtration rate in both situations. SLEDAI-2K score = 6 at selection period.
5.Women subjects of childbearing potential must use a highly effective method of contraception to prevent pregnancy. 6. History of vaccinations against S. pneumococcus, H. influenza and seasonal vaccinations, as required.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Use of corticoids, mycophelolate, cyclophosphamide above doses permitted for induction, according to the Consensus Document of the Group of Systemic Autoimmune Diseases of the Spanish Society of Internal Medicine and the Spanish Society of Nephrology.
2.Use of rituximab, belimumab or ocrelizumab, or other B cell-directed biologic therapies within 1 yr before treatment.
3.Use of abatacept within 1 yr before treatment.
4.Use of any tumor necrosis factor (TNF) inhibitor therapy within 1 yr before selection.
5.Use of immunoglobulin treatment within 1 yr before treatment.
6.Change in dosage of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) within 2 months before treatment.
7.Treatment with other investigational agents within the last 3 months or 5 half-lives prior to treatment.
8.Exclusion criteria related to medical conditions:
a.Any condition that in the investigator´s opinion constitutes an unnecessary risk or a counterindication for participation.
b.History of or planned renal or other organ transplant.
c.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.
d.Diagnosis of active tuberculosis, or latent tuberculosis infection.
e.History of cancer.
f.History of major surgery within 6 months prior to treatment.
g.Lactating women.
h.Legal incapacity or limited legal capacity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified