There were no deaths, no serious adverse events and no discontinuations related to study drug. There were no DLT reported. The most common treatment emergent adverse events were mucositis, pruritis/rash or erythema, decreased appetite. One infusion-related reaction (Grade 2) was reported in 1 ...
DLT was defined as any grade 4 to 5 or any related grade 3 toxicity that occurred within 48 hours of infusion with the exception of hematologic toxicities, fever alone, and common toxicities known to the related to the transplant procedure (eg, neutropenia). Any grade ≥ 2 neurotoxicity ...
The primary outcome was to determine the DLT to define the RP2D for the phase 2 trial. There were no immediate reaction complications or septic events in none of the infusions. The only mild side effect reported occurred in patient #7 (high dose cohort), considered directly related to the ...
Renal perfusion was reduced immediately after MSC administration which coincided with the presence of microthrombi in the glomeruli and signs of an instant blood-mediated inflammatory reaction. At two weeks post-treatment, the kidneys that were treated with one hundred million MSCs showed reduced skG...