Mesenchymal Stromal Cells (MSC´s) in Renal Lupus

Achievement of Complete Renal Response (CR) at Study Endpoint

Proportion of Patients that achieve CR criteria including: 1) Urinary Protein:Creatinine (UPC) ratio \< 0.5; 2) estimated Glomerular Filtration Rate (GFR) ≥ 120 ml/min/m2, or at least 80% of baseline; 3) urinalysis \< 10 red blood cells (RBC) and no RBC casts per high power field; 4) Prednisone dose ≤10 mg/day.

Time frame: 12 months

Achievement of Partial Renal Response (PR) at Study Endpoint

Proportion of Patients that achieve PR criteria including: 1) reduction of UPC ratio to at least 50% of baseline; 2) estimated GFR ≥120 ml/min/m2, or at least 80% of baseline; 3) Prednisone dose ≤10 mg/day.

Time frame: 12 months

Treatment Failure

Proportion of Patients that fulfill any of the following criteria for Treatment Failure including: 1) Daily Prednisone dose cannot be reduced ≤ 10 mg at week 24; 2) Daily Prednisone is increased above 10 mg after week 24; 3) Introduction of a new immunosuppressive regimen, not included in the trial; 4) Use of Rituximab prior to month 12.

Time frame: 24 weeks and 12 months

Response of SLE Responder Index (SRI).

Proportion of Patients that achieve SRI response, defined as a \>4-point reduction in the SELENA-SLEDAI score, no new British Isles Lupus Assessment Group \[BILAG\] A organ domain score and no more than 1 new BILAG B score, with no worsening in physician's global assessment score versus baseline). The Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the SLE Disease Activity Index (SLEDAI) is employed for this calculation.(SELENA-SLEDAI score). The SELENA-SLEDAI score addresses 24 descriptors in 9 organ-systems. Disease worsening increases the score that ranges from 0-105. The BILAG addresses 97 items in organ-system domains, in an ordinal (A-E) scale, converted to a numerical (0-96) scale for usual calculations.