Treatment-emergent adverse events after infusion of adherent stem cells: the MiSOT-I score for solid organ transplantation.
Trials
; 13: 211, 2012 Nov 15.
Article
em En
| MEDLINE
| ID: mdl-23151227
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 retrospectively on a cohort of n=187 recipients of liver allografts not receiving investigational cell therapy between July 2004 and December 2010. These patients represent a control population for further trials. Score values were calculated for days 1, 4, and 10 after liver transplantation.RESULTS:
Grade 3 events were most commonly related to the pulmonary system (3.5% of study cohort on day 4). Almost no systemic-related TEAEs were observed during the study period. The relative frequency of grade 3 events never exceeded 5% over all modalities and time points. A subgroup analysis for grade 3 patients provided no descriptors associated with severe TEAEs.CONCLUSION:
The MiSOT-I score provides an assessment tool to score specific adverse events that may occur after adherent stem cell therapy in the clinical setting of organ transplantation and is thus a helpful tool to conduct a safety study.
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Base de dados:
MEDLINE
Assunto principal:
Complicações Pós-Operatórias
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Técnicas de Apoio para a Decisão
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Transplante de Fígado
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Transplante de Células-Tronco
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article