RESUMO
Therapies to reduce liver fibrosis and stimulate organ regeneration are urgently needed. We conducted a first-in-human, phase 1 dose-escalation trial of autologous macrophage therapy in nine adults with cirrhosis and a Model for End-Stage Liver Disease (MELD) score of 10-16 (ISRCTN 10368050). Groups of three participants received a single peripheral infusion of 107, 108 or up to 109 cells. Leukapheresis and macrophage infusion were well tolerated with no transfusion reactions, dose-limiting toxicities or macrophage activation syndrome. All participants were alive and transplant-free at one year, with only one clinical event recorded, the occurrence of minimal ascites. The primary outcomes of safety and feasibility were met. This study informs and provides a rationale for efficacy studies in cirrhosis and other fibrotic diseases.
Assuntos
Terapia Baseada em Transplante de Células e Tecidos/métodos , Doença Hepática Terminal/terapia , Cirrose Hepática/terapia , Macrófagos/transplante , Idoso , Terapia Baseada em Transplante de Células e Tecidos/efeitos adversos , Relação Dose-Resposta Imunológica , Doença Hepática Terminal/imunologia , Doença Hepática Terminal/patologia , Feminino , Humanos , Fígado/metabolismo , Fígado/patologia , Cirrose Hepática/imunologia , Cirrose Hepática/patologia , Regeneração Hepática , Macrófagos/imunologia , Masculino , Pessoa de Meia-IdadeRESUMO
Priapism is a time-dependent emergency, which can lead to marked adverse effects on erectile function. We present the case of a patient with bipolar disorder who consumed a novel psychoactive substance, as well as an illegal substitute for sildenafil citrate. History revealed erectile dysfunction most likely secondary to hyperprolactinaema. This case, therefore, raises the question of whether this patient demographic should be routinely screened for this complaint.
