Treating Type 1 Diabetes by Pancreas Transplant Alone: A Cohort Study on Actual Long-term (10 Years) Efficacy and Safety

Boggi, Ugo; Baronti, Walter; Amorese, G; Pilotti, Silvia; Occhipinti, Margherita; Perrone, Vittorio; Marselli, Lorella; Barsotti, M; Campani, Daniela; Gianetti, Elena; Insilla, Andrea Cacciato; Bosi, Emanuele; Kaufmann, Emanuele; Terrenzio, Chiara; Vistoli, Fabio; Marchetti, Piero

doi:10.1097/tp.0000000000003627

Cited by 16 publications

(16 citation statements)

References 66 publications

(158 reference statements)

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“…Pancreas transplantation in unstable patients with type I diabetes restores normoglycemia and avoids disease-associated complications. 109 Although considered a quality-of-life operation, data suggest the lifesaving nature of pancreas transplantation 110 ; however, IRI-associated pancreatitis and thrombosis can negatively impact transplantation outcomes. NMP may ameliorate pancreas IRI and allow β-cell function assessment before transplantation.…”

Section: Promising Nmp Systems In Other Organsmentioning

confidence: 99%

Normothermic Machine Perfusion Systems: Where Do We Go From Here?

2023

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Normothermic machine perfusion (NMP) aims to preserve organs ex vivo by simulating physiological conditions such as body temperature. Recent advancements in NMP system design have prompted the development of clinically effective devices for liver, heart, lung, and kidney transplantation that preserve organs for several hours/up to 1 d. In preclinical studies, adjustments to circuit structure, perfusate composition, and automatic supervision have extended perfusion times up to 1 wk of preservation. Emerging NMP platforms for ex vivo preservation of the pancreas, intestine, uterus, ovary, and vascularized composite allografts represent exciting prospects. Thus, NMP may become a valuable tool in transplantation and provide significant advantages to biomedical research. This review recaps recent NMP research, including discussions of devices in clinical trials, innovative preclinical systems for extended preservation, and platforms developed for other organs. We will also discuss NMP strategies using a global approach while focusing on technical specifications and preservation times.

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Section: Promising Nmp Systems In Other Organsmentioning

confidence: 99%

Normothermic Machine Perfusion Systems: Where Do We Go From Here?

2023

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“…After pancreas transplantation was performed, the interest of conducting numerous studies concerning porcine islets transplantation emerged, which revealed it to be a promising treatment to cure diabetic patients 61 . Regarding the autologous regulatory T cell, no negative effects were seen related to the T regulatory cells infusion, regardless of cell dose.…”

Section: Therapeutic Valuementioning

confidence: 99%

Current state of clinical trials on xenograft

Masri

Afyouni

Ghazi

et al. 2023

Xenotransplantation

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Background: Xenotransplantation is a worth investing branch of science, since it aims to fulfil the demand on human cells, tissues and organs. Despite decades of consistent work in preclinical assessments, clinical trials on xenotransplantation are far from reaching the targeted goal. Our study aims to track the characteristics, assess the content and summarize the plan of each trial on skin, beta-island, bone marrow, aortic valve and kidney xenografts, leading to a clear sorting of efforts made in this field. Methods: In December 2022, we searched clinicaltrial.gov for interventional clinical trials related to xenograft of skin, pancreas, bone marrow, aortic valve and kidney. A total of 14 clinical trials are included in this study. Characteristics on each trial were gathered. Linked publications were searched using Medline/PubMed and Embase/Scopus. Content of trials was reviewed and summarized. Results: Only 14 clinical trials met our study's criteria. The majority were completed, and most of the trials' enrolment was between 11 and 50 participants. Nine trials used a xenograft of porcine origin. Six trials targeted skin xenotransplantation, four targeted β-cells, two targeted bone marrow and one trial targeted each of the kidney and aortic valve. The average length of trials was 3.38 years. Four trials were conducted in the United States and two trials in each of Brazil, Argentina and Sweden. Of all the included trials, none had any results provided and only three had published work. Phases I, III, and IV had only one trial each. A total of 501 participants were enrolled in these trials. Conclusion: This study sheds the light on the current state of clinical trials on xenograft. Characteristically, trials on this field are of low number, low enrolment, short duration, few related publications and no published results. Porcine organs are the most used in these trials, and skin is the most studied organ. An extension of the literature is highly needed due to the variety of conflicts mentioned. Overall, this study sheds the light on the necessity of managing research efforts, leading to the initiation of more trials targeting the field of xenotransplantation.

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“…Additionally, candidates with potentially life-threatening metabolic complications from hyperlabile diabetes, such as hypoglycemia unawareness, recurrent episodes of ketoacidosis, or progressive nonrenal complications may benefit from pancreas transplant alone (PTA) in the absence of a kidney transplant [10,11,12 ▪ ,13 ▪ ]. For this group of patients, it is essential that renal function be preserved in order to proceed with PTx.…”

Section: Options For Pancreas and Kidney Transplantation In Patients ...mentioning

confidence: 99%

“…Consequently, PTA became a Medicare-approved procedure in April 2006. A successful PTx is currently the only definitive long-term treatment that restores normal glucose homeostasis and may prevent, stabilize, or even reverse progressive diabetic complications [10,11,12 ▪ ,20–27]. Guidelines for referral for PTx are listed in Fig.…”

Section: Options For Pancreas and Kidney Transplantation In Patients ...mentioning

confidence: 99%

Modern indications for referral for kidney and pancreas transplantation

Fridell

Stratta

2022

Current Opinion in Nephrology &Amp; Hypertension

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Purpose of review Pancreas transplantation (PTx) is currently the only therapy that can predictably achieve sustained euglycemia independent of exogenous insulin administration in patients with insulin-dependent diabetes mellitus. This procedure involves a complex abdominal operation and lifetime dependence on immunosuppressive medications. Therefore, PTx is most frequently performed in combination with other organs, usually a kidney transplant for end stage diabetic nephropathy. Less frequently, solitary PTx may be indicated in patients with potentially life-threatening complications of diabetes mellitus. There remains confusion and misperceptions regarding indications and timing of patient referral for PTx. Recent findings In this review, the referral, evaluation, and listing process for PTx is described, including a detailed discussion of candidate assessment, indications, contraindications, and outcomes. Summary Because the progression of diabetic kidney disease may be less predictable than other forms of kidney failure, early referral for planning of renal and/or pancreas transplantation is paramount to optimize patient care and allow for possible preemptive transplantation.

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Treating Type 1 Diabetes by Pancreas Transplant Alone: A Cohort Study on Actual Long-term (10 Years) Efficacy and Safety

Cited by 16 publications

References 66 publications

Normothermic Machine Perfusion Systems: Where Do We Go From Here?

Normothermic Machine Perfusion Systems: Where Do We Go From Here?

Current state of clinical trials on xenograft

Modern indications for referral for kidney and pancreas transplantation

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