Feasibility and efficacy of combined pancreatic islet-lung transplantation in cystic fibrosis related diabetes -PIM study: a multicenter phase 1-2 trial.
Study design (if review, criteria of inclusion for studies)
Multicenter, prospective, phase 1-2 trial
Participants
10 participants (age: 24 years [17-31], with CFRD, terminal respiratory failure and poorly controlled diabetes. Diabetes duration: 8 years [4-12])
Interventions
Combined pancreatic islet-lung transplantation from a single donor with 2892 IEQ/kg [2293 - 6185].
Outcome measures
At one year, the primary outcome was transplant success as evaluated by a composite score including four parameters (weight, fasting glycaemia, HbA1c, insulin requirements).
Main results
Transplant success was achieved in 7/10 participants at one year post-transplant. Fasting plasma C-peptide increased from 0.91μg/L [0.56-1.29] to 1.15μg/L [0.77-2.2], HbA1c decreased from 7.8% [6.5-8.3] (62 mmol/mol [48-67]) to 6.7% [5.5-8.0] (50 mmol/mol [37-64]), with 38% decrease in daily insulin doses. No complications related to the islet injection procedure were reported.
Authors' conclusions
In this pilot study, combined pancreatic islet-lung transplantation restored satisfactory metabolic control and pulmonary function in patients with CF, without increasing the morbidity of lung transplantation.