Clinical transplantation

The transplantation program started in San Raffaele in 1985. The Transplant Unit represents a major part of the Department of Medicine performing kidney, pancreas and islet transplantation. The personnel of the Unit is following directly all the transplanted patients and is available h24 to cover all the clinical needs of the patients.

A tight cooperation with the surgical department and with all the clinical services of the Hospital constitutes the ideal setting for the development of phase 2 and 3 clinical trials in clinical transplantation.

Main conditions treated

At San Raffaele the following transplants are performed:

  • pancreas
  • kidney
  • islets of Langerhans

These transplants are performed as a single procedure or combined (kidney pancreas, kidney islets, double kidneys). Patients who can benefit of these transplants are:

  • Diabetic uremic patients in dialysis or pre dialysis
  • Uremic patient in dialysis or pre-dialysis
  • Unstable Type 1 diabetic patients

Research

The leading role of San Raffaele in Transplantation is confirmed by an intense scientific activity (more that 200 papers published in the last 10 years), making San Raffaele a reference center for pancreas and islet transplantation. The main fields of research activities of the Unit are focused on:

  1. Islet transplantation
  2. Chronic allograft nephropathy (CAN) after kidney transplantation
  3. Cell therapy in living-donors kidney transplantation (The One Study)
  4. Impact of pancreas transplantation on degenerative complications of diabetes
  5. Clinical trials

1 – Two studies stemmed from pilot studies on feasibility , safety and efficacy of intervention strategies on engraftment and peri-transplant environment:

  • Phase 2 single center, randomized open study: bone marrow versus liver as site for islet transplantation in patients with type 1 diabetes: pilot study to evaluate efficacy
  • A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation.

2 – CAN remains the leading cause of late graft loss after kidney transplantation. Characterized by progressive tubular atrophy and interstitial fibrosis (TA/IF) as well as microvascular and glomerular damage in the setting of declining graft function months to years after transplantation.

3 – The ONE Study (website). This is a large-scale, collaborative project funded by the Seventh Framework Programme (FP7) of the European Commission. The consortium is composed of academic institutions and industrial partners. It is aimed to test several distinct purified haematopoietic immunoregulatory cells as clinical therapies in solid organ transplantation by initiating a series of independent clinical trials. The ultimate goal is the reduction of long-term immunosuppressive therapy.

4 – Impact of kidney-pancreas transplantation on diabetic enteropathy in diabetic uremic patients, studied through rectal biopsies, circulating markers and functional tests.

5 – Clinical trials ongoing:

  • RAD001 multicenter, randomized, open label study to evaluate the impact of early vs delayed introduction of everolimus on wound healing in kidney transplant (NEVERWOUND)
  • A phase 2 multicenter pilot study to assess the efficacy and safety of reparixin following islet transplantation.
  • Planned Transition to Sirolimus-based Therapy Versus Continued Tacrolimus-based Therapy in Renal Allograft Recipients
  • Pilot study to assess feasibility and safety of bone-marrow as alternative site in islet transplantation

Staff

ClinTransplantHead of Unit is Antonio Secchi, Professor at Università Vita-Salute San Raffaele.

Medical staff: Rossana Caldara, Paola Maffi, Ennio La Rocca, Chiara Gremizzi, Vera Paloschi, Giorgio Gentile Post-Doctoral fellows: Andrea Pontara, Luca franco, Wen Zhenhua. Consultant: Paolo Fiorina. MD Data manager: Erica Borghini PhD and Paola Magistretti, PhD. Secretarial staff: Serena Oggioni, Eleonora Meroni, Valeria Cipolla.