Treatment-emergent adverse events after infusion of adherent stem cells: the MiSOT-I score for solid organ transplantation.

ABSTRACT:

Background

Cellular therapy after organ transplantation is emerging as an intriguing strategy to achieve dose reduction of classical immunosuppressive pharmacotherapy. Here, we introduce a new scoring system to assess treatment-emergent adverse events (TEAEs) of adherent stem cell therapies in the clinical setting of allogeneic liver transplantation (for example, the MiSOT-I trial Eudract CT: 2009-017795-25).

Methods

The score consists of three independent modalities (set of parameters) that focus on clinically relevant events early after intravenous or intraportal stem cell infusion: pulmonary toxicity, intraportal-infusional toxicity and systemic toxicity. For each modality, values between 0 (no TEAE) and 3 (severe TEAE) were defined. The score was validated retrospectivel

SUBMITTER: Dillmann J 

PROVIDER: S-EPMC3543274 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature