Dose-dependent Immunomodulatory Effect of Intravenous Allogeneic Umbilical Cord-Derived Mesenchymal Stromal Cells (Cytopeutics CLV-100) Infusion in Healthy Volunteers

Conclusion MethodologyUmbilical cord samples were collected after delivery of full-term, healthy babies with written consent from both parents. All 3 generations (newborn, parents and grandparents) were screened for genetic mutations, infections, cancers and other inherited diseases. Samples were transferred to a certified Good Manufacturing Practice laboratory for processing. Subjects were infused with either low dose (LD, 65 million cells) or high dose (HD, 130 million cells) of CLV-100 followed up for 6 months. We measured cytokines level using ELISA including the acute phase reactant high-sensitivity C-reactive protein (hs-CRP), anti-inflammatory cytokines interleukin 1 receptor antigen (IL-1RA) and interleukin 10 (IL-10), and the pro-inflammatory cytokine Tumor Necrosis Factor-Alpha (TNF-α). The study was approved by the National Medical Research and Ethics Committee (MREC).Results11 healthy subjects (LD, n=5; HD, n=6; mean age of 55±13 years) were recruited. All subjects tolerated the CLV-100 infusion well with no adverse reaction throughout the study. While there was no change in vital parameters and routine blood tests, there was a transient rise in hs-CRP at Day 3 post infusion (1.2±1.5 vs. 4.5±3.9 mg/L; p=0.03) which resolved at Day 7. The anti-inflammatory IL-1RA was significantly elevated in HD patients at 1 month post infusion (436±128 vs. 615±148 pg/mL; p=0.028). At 6 months, HD group had significantly higher levels of anti-inflammatory markers IL1-RA (705...
Source: Cytotherapy - Category: Cytology Source Type: research