Dataset Information

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 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.

SUBMITTER: Dillmann J

PROVIDER: S-EPMC3543274 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Dillmann Johannes J Popp Felix C FC Fillenberg Barbara B Zeman Florian F Eggenhofer Elke E Farkas Stefan S Scherer Marcus N MN Koller Michael M Geissler Edward K EK Deans Robert R Ladenheim Deborah D Loss Martin M Schlitt Hans J HJ Dahlke Marc H MH

Trials 20121115

<h4>Background</h4>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).<h4>Methods</h4>The score consists of three independent modalities (set of param ...[more]

PMID: 23151227

Similar Datasets

Project description:PurposeMetabolic and bariatric surgery (MBS) is increasingly performed in patients with previous solid organ transplantation (PSOT). In addition, controversy remains about whether racial disparity in outcomes following MBS exists. Therefore, the aim of this analysis was to determine if race independently predicts outcomes in MBS patients with PSOT.Materials and methodsPatients with PSOT undergoing sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) were identified in the 2017 Metabolic and Bariatric Surgery Accreditation Quality and Improvement Project (MBSAQIP) database. Patients were stratified by race (Black and White). Propensity score matching was utilized to adjust for multiple demographic variables. Multivariable logistic regression analyses were performed for overall and bariatric-related morbidity.ResultsOf 335 MBS patients with PSOT, 250 (75%) were white and 85 (25%) were black patents. Procedure-type and surgical approach (p > 0.1) were similarly distributed. Black patients were more likely (p < 0.05) to have hypertension dialysis-dependent chronic kidney disease, and be on chronic steroids). Mortality and morbidity were similar. Black patients had significantly (p < 0.05) higher rates of renal failure, pulmonary complications, and emergency department visits in unmatched analysis. After propensity score matching, 82 patients in each cohort were identified and were similar at baseline (p > 0.5). In the matched analysis, black patients had higher overall (17% vs. 10%, p = 0.12) and bariatric-related morbidity (14% vs. 7.2%, p = 0.05). In addition, black patients had significantly (p < 0.05) higher rates of postoperative pneumonias, progressive renal insufficiency, and emergency department visits. On multivariable regression analysis, black race did not independently predict overall or bariatric-related morbidity.ConclusionMBS in racial cohorts with PSOT is safe, with very low rates of overall morbidity and mortality. Black race trended toward increased postoperative morbidity. Larger cohort studies are needed to validate our findings.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets