Study: NCT06737380

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Clinical laboratory evaluations - Serology
Description: Serological assessment for history of HIV, active hepatitis B and C infection and TB will be performed at the Screening visit only (2ml). CMV screen will also be performed but CMV positive subjects will not be excluded. Participants that are CMV IgG antibody positive but not actively infected will receive cells from a CMV antibody + positive donor while CMV antibody negative participants will receive cells from a CMV antibody negative donor.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Clinical laboratory evaluations - Biochemistry
Description: The panel will include analysis of albumin, blood urea nitrogen (BUN), creatinine, glucose, uric acid, calcium, phosphorus, potassium, sodium, lactate dehydrogenase (LDH), total protein, magnesium, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and hs-CRP. For biochemistry, 3 mL blood will be collected at each study visit. Results relating to inclusion criteria must be confirmed within 7 days prior to Day 1.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Clinical laboratory evaluations - Hematology
Description: The complete blood count (CBC) will include: hemoglobin, hematocrit, white blood cells (WBCs) with complete manual or automated differential (total neutrophils, lymphocytes, monocytes, eosinophils, basophils; absolute or percentage will be acceptable), red blood cells (RBCs), platelet count. For CBC, 1mL blood will be collected at each study visit.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pregnancy Test
Description: A STAT serum b-hCG will be performed in women of child- bearing age, within 7 days prior to study treatment. A negative result must be available prior to study treatment administration. Urine pregnancy tests will also be performed in women of child-bearing age at each study visit. Pregnancy tests are not required for women unable to become pregnant for one of the following reasons: Menopause confirmed by healthcare provider, verbally reported by a participant that she has had her uterus or both ovaries or both fallopian tubes removed.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Urinalysis
Description: General urinalysis will include analysis of pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, leukocytes, erythrocytes. In addition samples will be assessed for presence of urinary casts. Spot urine protein/creatinine measure will be done at each visit. If no casts are observed at Screening, then machine assessment of further urinary samples is allowed. For urinalysis, 10mL urine will be collected at each study visit.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: SLE activity evaluation
Description: SLE status will be assessed using the Safety of Estrogens in Lupus Erythematosus National Assessment- SLE Disease Activity Index (SLEDAI 2K scale).SLE activity will also be assessed using British Isles Lupus Assessment Group (BILAG), physician global and participant global assessment allowing use of the Systemic Lupus Responder Index (SRI 4) and the BILAG-based Composite Lupus Assessment (BICLA) instruments to assess clinical response.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: SLE biomarker profiling
Description: SLE biomarkers will be profiled at the study visit (Day 1) and at every subsequent follow up visit. For this purpose, urine and 10 ml blood will be collected.~Anti-ENA, Anti-dsDNA antibodies, total serum IgG levels, CBC, C3, C4, anti-nucleosome antibodies, erythrocyte sedimentation rate, CRP, protein/creatinine ratio in spot urine, 24-hour urine protein - Day 1 - Baseline and at end of study visit only; Mononuclear cell changes. This analysis includes lymphocyte subsets and innate immune cell subsets

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Cytokines and chemokine profiling
Description: Serum cytokines and chemokines will be profiled at the study visit (Day 1) and at every subsequent follow-up visit. Cytokines (Type 1 IFN: IFN-α, IFN-β, IFN- γ, IFN-ω, IFN-κ, IL 2, 4, 12, 18, 23, 10).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: single dose of UC-MSCs
Description: participants will be treated on Baseline Day 1 with a UC-MSCs product administered subcutaneously. Participants will be observed for 2 to 3 hours after end of study treatment and then followed up for safety assessments over the subsequent 6-month period.