INSIDE OUR LABS: RODOLFO ALEJANDRO, M.D. & DAVID BAIDAL, M.D.
Rodolfo Alejandro, M.D., is Director of Clinical Cell Transplantation and Co-Director of the Cell Transplant Center at the Diabetes Research Institute (DRI) and has overseen the Clinical Cell Islet Transplant Program (CCTP) since 1985. He also held the position of Director of the cGMP cell processing center. He is Professor of Medicine at the University of Miami Miller School of Medicine and board certified in internal medicine and endocrinology, diabetes, and metabolism . Dr. Alejandro is a renowned expert in the field of islet transplantation, having published over 150 peer reviewed scientific papers, as well as multiple abstracts and book chapters. He is known worldwide for his discovery of dithizone staining, an efficient and accurate islet staining and quantification method . Additional seminal contributions to the field include the use of the Cobe Cell processor for islet separation, the institution of the islet culture approach for better characterization of the product prior to clinical islet transplantation, introducing the percutaneous transhepatic approach for islet transplantation, and describing the “Bag Method” for islet infusion.
The Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine in Miami, Florida first began performing clinical islet transplantation in 1985. Since then, our center has blossomed into one of the largest independent centers worldwide, with 57 transplant recipients totaling 101 islet infusions since the year 2000 . Several patients continue to be followed many years after their initial transplant at the DRI. Funding for this long-term follow up has been provided by Dr. Alejandro’s DRIF funded project entitled “Islet Cell Transplantation Alone in Patients with Type 1 Diabetes Mellitus: Steroid-Free Regimen: Long Term Follow Up of Subjects with Graft Function and after Graft Failure” which aims at evaluating the long-term impact of islet transplantation on patient safety, glucose control, duration of insulin independence, diabetes related complications, quality of life, and mortality. Findings from this follow up study have led to multiple scientific publications which have advanced the field and our understanding of the metabolic and immunologic effects of islet transplantation.
Most recently, the CCTP demonstrated safety and efficacy of islet transplantation on the omentum using a biologic scaffold . So far, the procedure has been deemed safe, and islets have survived in the biological scaffold and engrafted on the surface of the omentum. Results are highly encouraging and highlight the potential of this novel technique and transplantation site, which warrants further investigation. However, a major limiting factor is the low oxygenation that islets receive on the omentum prior to revascularization which likely accounts for a substantial loss of islets early post-transplantation.
Dr. Alejandro is additionally working on another clinical trial alongside Dr. David Baidal (Principal Investigator) entitled “A Pilot, Safety, and Feasibility Trial of High-Dose Omega-3 Fatty Acids and High-Dose Cholecalciferol Supplementation in Type 1 Diabetes” with the aim to test whether the use of high doses of vitamin D3 and highly purified Omega-3 fatty acids can preserve residual beta-cell function in subjects with new onset and established type 1 diabetes (T1D). Participants in this study will be grouped as either new onset T1D (≤6 months duration) or established T1D (>10 years duration).
In 2021, the CCTP and Vertex Pharmaceuticals Incorporated initiated a clinical trial testing their investigational product VX-880. This product comprises human embryonic stem cell-derived islets, a novel investigational cell therapy with the potential to restore normal glucose control in those suffering from T1D with severe hypoglycemia and impaired hypoglycemic awareness. The DRI was the first clinical site activated for this trial. This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in T1D patients.
Dr. Alejandro is a leader in the field of islet transplantation, and his work has revolutionized the understanding and clinical care for individuals undergoing islet transplantation. The continued long-term care and follow-up for subjects in these studies will provide information that will contribute to improving transplant outcomes for future islet transplant recipients.
Research summary written by Neha Majety, The (Sugar) Science
1. Diabetes Research Institute. “Rodolfo Alejandro, M.D.”
2. Latif Z, Noel J, and Alejandro, R. A simple method for staining of fresh and cultured islets. Transplantation 45(4):827-830, 1988.
3. Camhi SS, Baidal D, Alejandro R, Alvarez A, Padilla N, Linetsky E, Kenyon NS, Ricordi C: Treating Diabetes with islet transplantation: lessons from the University of Miami. In: Orlando G, Piemonti L, Ricordi C, Stratta RJ, and Gruessner RWG, (eds). Transplantation, Bioengineering, and Regeneration of the Endocrine Pancreas, Volume 1. San Diego: Elsevier Inc./Academic Press, 2020: 659-670.
4. Lemos JRN, Baidal DA, Ricordi C, Fuenmayor V, Alvarez A, Alejandro R Survival After Islet Transplantation in Subjects With Type 1 Diabetes: Twenty-Year Follow-Up. Diabetes Care. 2021 Apr; 44(4):e67-e68. doi: 10.2337/dc20-2458. Epub 2021 Feb 12. PMID: 33579716
5. Lemos JRN, Baidal DA, Poggioli R, Fuenmayor V, Chavez C, Alvarez A, Linetsky E, Mauvais-Jarvis F, Ricordi C, Alejandro R. Prolonged Islet Allograft Function is Associated With Female Sex in Patients After Islet Transplantation. J Clin Endocrinol Metab. 2022 Feb 17;107(3):e973-e979. doi: 10.1210/clinem/dgab787. PMID: 34727179; PMCID: PMC8852206.
6. Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635. PMID: 33481552; PMCID: PMC8289921.
7. Baidal DA, Ricordi C, Berman DM, Alvarez A, Padilla N, Ciancio G, Linetsky E, Pileggi A, Alejandro R. Bioengineering of an Intraabdominal Endocrine Pancreas. N Engl J Med. 2017 May 11;376(19):1887-1889.