Insulin Independence Following Isolated Islet Transplantation and Single Islet Infusions
Open accessAbstract
Objective To restore islet function in patients whose labile diabetes subjected them to frequent dangerous episodes of hypoglycemic unawareness, and to determine whether multiple transplants are always required to achieve insulin independence. Summary background data The recent report by the Edmonton group documenting restoration of insulin independence by islet transplantation in seven consecutive patients with type 1 diabetes differed from previous worldwide experience of only sporadic success. In the Edmonton patients, the transplanted islet mass critical for success was approximately more than 9,000 IEq/kg of recipient body weight and required two or three separate transplants of islets isolated from two to four cadaveric donors. Whether the success of the Edmonton group can be recapitulated by others, and whether repeated transplants using multiple donors will be a universal requirement for success have not been reported. Methods The authors report their treatment with islet transplantation of nine patients whose labile type 1 diabetes was characterized by frequent episodes of dangerous hypoglycemia. Results In each of the seven patients who have completed the treatment protocol (i.e., one or if necessary a second islet transplant), insulin independence has been achieved. In five of the seven patients only a single infusion of islets was required. To date, only one recipient has subsequently lost graft function, after an initially successful transplant. This patient suff…
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Assuming a similar dose as with human islets from deceased donors, on the order of 10^9 cells will be required per patient.
“Assuming a similar dose as with human islets from deceased donors,175,176 on the order of 109 cells will be required per patient.”
From Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes (2023) · cites this paper as [175]
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BackgroundInfluentialSelf-citationHuman Islet Oxygen Consumption Rate and DNA Measurements Predict Diabetes Reversal in Nude Mice
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“In this study we examined the ability of 2 parameters characterizing human islet quality: (1) OCR, a measure of viable volume and (2) OCR/DNA, a measure of FV, to predict DR in nude mice.”
BackgroundMethodInfluentialState of the Art of Clinical Islet Transplantation and Novel Protocols of Immunosuppression
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“P islet transplantation is a promising treatment for those living with type 1 diabetes (1, 2), but this therapy has limitations (3, 4).”
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Magnetic Resonance-Defined Periportal Steatosis Following Intraportal Islet Transplantation
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“Similar decreases in insulin response to glucose have been reported in an allograft porcine model of islet transplantation and in the clinical setting of patients who receive islet transplantation [27, 38].”
BackgroundRescue Purification Maximizes the Use of Human Islet Preparations for Transplantation
Ichii, H., Pileggi, A., Molano, R., Baidal, D., Khan, A., Kuroda, Y., Inverardi, L., Goss, J. A., Alejandro, R., & Ricordi, C. (2005) · American Journal of Transplantation · doi:10.1111/j.1600-6143.2005.00698.x · Cited by 116 · see citing works
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β-Cell Function Following Human Islet Transplantation for Type 1 Diabetes
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“tation at HUP has previously been reported (3).”
BackgroundSelf-citationRapamycin Causes Upregulation of Autophagy and Impairs Islets Function Both In Vitro and In Vivo
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“Rapamycin has deleterious effects on islet b cell based on the blockade of VEGF-mediated survival pathways and inhibition of b-cell proliferation and by induction of apoptosis (20,34,42).”
BackgroundHafiz, M. M., Faradji, R., Froud, T., Pileggi, A., Baidal, D., Cure, P., Ponte, G., Poggioli, R., Cornejo, A., Messinger, S., et al. (2005) · Transplantation · doi:10.1097/01.tp.0000187881.97068.77 · Cited by 111 · see citing works
Transplantation for Type I Diabetes
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“Since this landmark study, a number of other centers have confirmed the Edmonton results in small series of patients, including at least 2 that reported success with islets from single donors.(12,13) In the largest concerted effort to replicate the results of Edmonton, the National Institutes of Health–supported “Immu…”
ResultSelf-citationNew insights into the architecture of the islet of Langerhans: a focused cross-species assessment
Drigo, R. A. E., Ali, Y., Diez, J. A., Srinivasan, D. K., Berggren, P., & Boehm, B. (2015) · Diabetologia · doi:10.1007/s00125-015-3699-0 · Cited by 103 · see citing works
“dependency on exogenous insulin application as quickly as 20 days after islet transplantation [61], well before complete islet innervation is established.”
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“Islets were isolated using a modified Ricordi method (13) with Liberase enzyme (Roche, Indianapolis, IN) (14) as previously described (15).”
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“CD3+ count (cell/mm3) 24 (15-43) 36 (9-83) 0.”
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“The procedure for islet transplantation at HUP has been previously reported (18).”
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“Islet transplantation requires infusion of high-quality islets isolated from a total of two to four donors to treat one recipient (Markmann et al., 2003).”
BackgroundIn Vivo Bioluminescence Imaging of Transplanted Islets and Early Detection of Graft Rejection
Chen, X., Zhang, X.-M., Larson, C., Baker, M., & Kaufman, D. (2006) · Transplantation · doi:10.1097/01.tp.0000206109.71181.bf · Cited by 85
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“Furthermore, recent advances in clinical islet cell transplantation have demonstrated an excellent outcome, improving the quality of life of patients (24,25).”
BackgroundTransduction of Human Islets with Pseudotyped Lentiviral Vectors
Kobinger, G., Deng, S., Louboutin, J., Vatamaniuk, M., Matschinsky, F., Markmann, J., Raper, S., & Wilson, J. M. (2004) · Human Gene Therapy · doi:10.1089/104303404772680010 · Cited by 84 · see citing works
Self-citationThe Effect of Pancreatic Islet Transplantation on Progression of Diabetic Retinopathy and Neuropathy
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Expectations and Strategies Regarding Islet Transplantation: Metabolic Data From the GRAGIL 2 Trial
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“Other groups have reported insulin independence with single donor transplantation (17, 18).”
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“Both AUC and AIR remained stable afterwards, in accordance with other reports (3,8).”
ResultImproved Human Islet Isolation Using Nicotinamide
Ichii, H., Wang, X., Messinger, S., Alvarez, A., Fraker, C., Khan, A., Kuroda, Y., Inverardi, L., Goss, J. A., Alejandro, R., et al. (2006) · American Journal of Transplantation · doi:10.1111/j.1600-6143.2006.01452.x · Cited by 77
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Allosensitization of Islet Allograft Recipients
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“By contrast, only 9.5% (4/42) of patients after 2000 displayed PRA by CDC while on immunosuppression (subjects 27, 29, 57, and 60; Table 2); only 7/42 subjects were IAK, with the majority being ITA (n 27) and I-BMT (n 8).”
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A Significant Role for Histocompatibility in Human Islet Transplantation
Mohanakumar, T., Narayanan, K., Desai, N., Ramachandran, S., Shenoy, S., Jendrisak, M., Susskind, B., Olack, B., Benshoff, N., Phelan, D., et al. (2006) · Transplantation · doi:10.1097/01.tp.0000226161.82581.b2 · Cited by 70 · see citing works
“The general requirement for multiple islet infusions also remains a significant issue despite the recent reports of successful reversal of diabetes following single donor transplant (4, 9).”
BackgroundResultSelf-citationUnraveling the Secrets of Single Donor Success in Islet Transplantation
Shapiro, A. M. J., & Ricordi, C. (2004) · American Journal of Transplantation · doi:10.1046/j.1600-6143.2003.00375.x · Cited by 63 · see citing works
“Notable progress includes the introduction of the perfluorodecalin (PFC) ‘two-layer’ method for pancreas protection during transportation and rescue of marginal donors (21– 25), successful single-donor islet transplants from obese, nonheart-beating donors (26,27), and the routine use of islet culture rather than immed…”
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“1194 transplantation (35, 36, 46), but generally requires sequential or pooled islet preparations obtained from two to three donor pancreata (28, 30, 35, 36, 47, 48).”
BackgroundReversal of diabetes in pancreatectomized pigs after transplantation of neonatal porcine islets.
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Islet isolation for clinical transplantation.
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“This protocol has set the standard worldwide for islet transplantation and now many other groups have attained similar success [3–5].”
BackgroundPancreatic islet transplantation: current advances and challenges
Wang, Q., Huang, Y.-X., Liu, L., Zhao, X.-H., Sun, Y., Mao, X.-L., & Li, S.-W. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1391504 · Cited by 63 · see citing works
“When islet transplant recipients reach the milestone of 5 years after their last islet cell infusion, approximately 95% of patients who meet these 4 common factors experience no SHEs and greatly bene fi t from improved glycemic control (13).”
BackgroundWeaver, J. D., Headen, D., Coronel, M. M., Hunckler, M. D., Shirwan, H., & García, A. J. (2018) · American Journal of Transplantation · doi:10.1111/ajt.15168 · Cited by 62 · see citing works
Pig islet xenograft rejection in a mouse model with an established human immune system
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Self-citationBeta-Cell Replacement for Type I Diabetes
Stock, P. G., & Bluestone, J. A. (2004) · Annual Review of Medicine · doi:10.1146/annurev.med.55.091902.103539 · Cited by 48 · see citing works
“Transplant groups from the University of Minnesota (34, 48) and University of Pennsylvania (49) have demonstrated consistent ability to achieve insulin independence from a single donor.”
BackgroundInfluentialIslet Transplantation: Progress and Challenge
Gaglia, J. L., Shapiro, A. M. J., & Weir, G. C. (2005) · Archives of Medical Research · doi:10.1016/j.arcmed.2005.03.014 · Cited by 49 · see citing works
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“Successful pancreatic islet transplantation achieves significantly better glycaemic control than is achieved with bolus insulin injections, with almost complete resolution of hypoglycaemia even with partial graft function [1–4].”
BackgroundIslet Size Index as a Predictor of Outcomes in Clinical Islet Autotransplantation
Suszynski, T., Wilhelm, J., Radosevich, D. M., Balamurugan, A., Sutherland, D., Beilman, G., Dunn, T., Chinnakotla, S., Pruett, T., Vickers, S., et al. (2014) · Transplantation · doi:10.1097/01.tp.0000441873.35383.1e · Cited by 50
Current Status of Islet Cell Transplantation
Ichii, H., & Ricordi, C. (2008) · Journal of Hepato-Biliary-Pancreatic Surgery · doi:10.1007/s00534-008-0021-2 · Cited by 49 · see citing works
“While selected centers have reported high rates of success [4, 6, 32, 33, 48, 56, 57, 78, 83], islet graft failures in the very early post-transplant period have been reported.”
InfluentialAllogeneic islet transplantation
Marzorati, S., Pileggi, A., & Ricordi, C. (2007) · Expert Opinion on Biological Therapy · doi:10.1517/14712598.7.11.1627 · Cited by 46 · see citing works
“Expert opinion The success rate of allogeneic islet transplantation for the treatment of patients with T1DM has steadily improved over the years.”
BackgroundMethodInfluentialHilling, D., Bouwman, E., Terpstra, O., & de Mheen, P. J. M.-V. (2014) · Cell Transplantation · doi:10.3727/096368913x666412 · Cited by 46
“However, successful islet isolations from DCD donors have also been reported previously (43,46,50,83).”
BackgroundRickels, M. R., Naji, A., & Teff, K. L. (2006) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2005-2519 · Cited by 45 · see citing works
Self-citationMita, A., Ricordi, C., Messinger, S., Miki, A., Misawa, R., Barker, S., Molano, R., Haertter, R., Khan, A., Miyagawa, S., et al. (2010) · Cell Transplantation · doi:10.3727/096368910x516600 · Cited by 44 · see citing works
“Further study will be needed to deusing islets generally obtained from multiple donors (16,29,45,46).”
BackgroundRickels, M., Kamoun, M., Kearns, J., Markmann, J., & Naji, A. (2007) · Journal of Clinical Endocrinology and Metabolism · doi:10.1210/jc.2007-0172 · Cited by 44 · see citing works
Self-citationConsiderations and Challenges of Islet Transplantation and Future Therapies on the Horizon.
Walker, S. L., Appari, M., & Forbes, S. (2021) · American Journal of Physiology. Endocrinology and Metabolism · doi:10.1152/ajpendo.00310.2021 · Cited by 43 · see citing works
“0001), 90 minute C-peptide concentrations following a mixed meal tolerance test at 1 114 year post first transplant, were not significantly different [80].”
BackgroundOvercoming the Challenges Now Limiting Islet Transplantation
Pileggi, A., Cobianchi, L., Inverardi, L., & Ricordi, C. (2006) · Annals of the New York Academy of Sciences · doi:10.1196/annals.1375.059 · Cited by 43 · see citing works
Health-Related Quality of Life after Pancreatic Islet Transplantation: A Longitudinal Study
Barshes, N. R., Vanatta, J. M., Mote, A., Lee, T. C., Schock, A. P., Balkrishnan, R., Brunicardi, F. C., & Goss, J. A. (2005) · Transplantation · doi:10.1097/01.tp.0000160816.21799.f5 · Cited by 41 · see citing works
Effect of Micro- and Macroencapsulation on Oxygen Consumption by Pancreatic Islets
Cornolti, R., Figliuzzi, M., & Remuzzi, A. (2009) · Cell Transplantation · doi:10.3727/096368909788341252 · Cited by 40 · see citing works
Characterization of Pancreatic Ductal Cell in Human Islet Preparations
Ichii, H., Miki, A., Yamamoto, T., Molano, R., Barker, S., Mita, A., Rodriguez-Diaz, R., Klein, D., Pastori, R., Alejandro, R., et al. (2008) · Laboratory Investigation · doi:10.1038/labinvest.2008.87 · Cited by 40
Jimenez‐Vera, E., Davies, S., Phillips, P. M., O’Connell, P. J., & Hawthorne, W. J. (2015) · Xenotransplantation · doi:10.1111/xen.12151 · Cited by 40 · see citing works
Immobilization of soluble complement receptor 1 on islets.
Nguyen, L. M., Teramura, Y., & Iwata, H. (2011) · Biomaterials · doi:10.1016/j.biomaterials.2011.03.017 · Cited by 39
Bosco, M. D., Mohanasundaram, D., Drogemuller, C., Lang, C. J., Zalewski, P. D., & Coates, P. T. (2010) · The Review of Diabetic Studies · doi:10.1900/rds.2010.7.263 · Cited by 34 · see citing works
“In this therapy, cadaveric human donor pancreata are enzymatically digested to create islets for infusion into the T1D recipient’s liver under immunosuppressive drug regimen [1-3].”
MethodRickels, M. R., Naji, A., & Teff, K. L. (2007) · Transplantation · doi:10.1097/01.tp.0000287595.16442.a7 · Cited by 39 · see citing works
Self-citationEckhoff, D., Eckstein, C., Smyth, C. A., Vilatoba, M., Bilbao, G., Rahemtulla, F., Young, C., Thompson, J. A., Chaudry, I., & Contreras, J. (2004) · Surgery · doi:10.1016/j.surg.2004.05.009 · Cited by 37 · see citing works
Oxygenation of the Intraportally Transplanted Pancreatic Islet
Suszynski, T., Avgoustiniatos, E., & Papas, K. (2016) · Journal of Diabetes Research · doi:10.1155/2016/7625947 · Cited by 36 · see citing works
Overcoming barriers in clinical islet transplantation: current limitations and future prospects.
Chhabra, P., Sutherland, D., & Brayman, K. (2014) · Current problems in surgery · doi:10.1067/j.cpsurg.2013.10.002 · Cited by 34 · see citing works
Self-citationGillard, P., Ling, Z., Mathieu, C., Crenier, L., Lannoo, M., Maes, B., Roep, B. O., Gorus, F., PIPELEERS, D. G., & Keymeulen, B. (2008) · Transplantation · doi:10.1097/tp.0b013e31815e8926 · Cited by 39 · see citing works
Small intestinal submucosa improves islet survival and function in vitro culture.
Xiaohui, T., Xue, W.-J., Xiaoming, D., Xinlu, P., Yan, T., Pux-un, T., & Xinshun, F. (2006) · Transplantation Proceedings · doi:10.1016/j.transproceed.2006.02.134 · Cited by 32
Omental roll-up: a technique for islet engraftment in a large animal model.
Hefty, T., Kuhr, C., Chong, K., Guinee, D., Wang, W.-J., Reems, J., & Greenbaum, C. (2010) · Journal of Surgical Research · doi:10.1016/j.jss.2008.11.842 · Cited by 31
Islet Alone vs. Islet After Kidney Transplantation: Metabolic Outcomes and Islet Graft Survival
Deng, S., Markmann, J., Rickels, M., Yeh, H., Kim, J. I., Lian, M.-M., Gu, Y., Markmann, E., Palanjian, M., Barker, C., et al. (2009) · Transplantation · doi:10.1097/tp.0b013e3181b4bdbb · Cited by 30 · see citing works
Self-citationEvgenov, N. V., Pratt, J., Pantazopoulos, P., & Moore, A. V. (2008) · Transplantation · doi:10.1097/tp.0b013e31816b183e · Cited by 28 · see citing works
“Overall, the low impact of contaminating tissue on the in vivo MR imaging of islet transplantation is evident from (1) the low level of iron uptake by low-purity islet preparation, (2) longer T2 relaxation times of labeled nonendocrine tissue and/or of labeled low-purity islets in vitro, (3) the high rate of cell deat…”
ResultChoong, F. J., Freeman, C., Parish, C., & Simeonovic, C. (2015) · American Journal of Transplantation · doi:10.1111/ajt.13366 · Cited by 28 · see citing works
One Hundred Human Pancreatic Islet Isolations at Baylor Research Institute
Takita, M., Matsumoto, S., Noguchi, H., Shimoda, M., Chujo, D., Sugimoto, K., Itoh, T., Lamont, J., Lara, L., Onaca, N., et al. (2010) · Proceedings · doi:10.1080/08998280.2010.11928648 · Cited by 26
“Markmann et al indicated that approximately 100 human islet isolations were necessary before initiating clinical islet transplantation (32).”
BackgroundDetection of Microbial Contamination during Human Islet Isolation
Kin, T., Rosichuk, S., Shapiro, A. M. J., & Lakey, J. (2007) · Cell Transplantation · doi:10.3727/000000007783464498 · Cited by 26
Small intestinal submucosa improves islet survival and function during in vitro culture.
Tian, X.-H., Xue, W., Ding, X.-M., Pang, X.-L., Teng, Y., Tian, P., & Feng, X.-S. (2005) · World Journal of Gastroenterology · doi:10.3748/wjg.v11.i46.7378 · Cited by 26
The effect of hypoxia on free and encapsulated adult porcine islets-an in vitro study
Muthyala, S., Safley, S., Gordan, K., Barber, G., Weber, C., & Sambanis, A. (2016) · Xenotransplantation · doi:10.1111/xen.12275 · Cited by 25 · see citing works
“Islet transplantation has proven to be a viable option for the treatment of people with Type 1 diabetes (1, 2) but the shortage of human cadaveric pancreata and deleterious consequences of long-term immunosuppression limit the of number of patients that can be treated to a small fraction of the…”
Effect of nicotinamide on early graft failure following intraportal islet transplantation
Jung, D., Park, J., Joo, S., Joh, J., Kwon, C., Kwon, G., & Kim, S.-J. (2009) · Experimental and Molecular Medicine · doi:10.3858/emm.2009.41.11.084 · Cited by 25
Anti-Pro-Inflammatory Effects of Sirolimus on Human Islet Preparations
Mita, A., Ricordi, C., Miki, A., Barker, S., Haertter, R., Hashikura, Y., Miyagawa, S., Burke, G., Inverardi, L., & Ichii, H. (2008) · Transplantation · doi:10.1097/tp.0b013e31817c79c0 · Cited by 24
Sutherland, D., Gruessner, R., Kandswamy, R., Humar, A., Hering, B., & Gruessner, A. (2004) · Transplantation Proceedings · doi:10.1016/s0889-8529(03)00099-9 · Cited by 23 · see citing works
“The unprecedented findings in recent islet transplant trials, first reported by Shapiro et al [39] and subsequently confirmed at additional institutions [44–46], marked a turning point in the history of islet transplantation, yet most patients required islets prepared from two or more donor pancreases.”
ResultNeonatal Sepsis in the Very Low Birth Weight Preterm Infants: Part 1: Review of Patho-physiology
Haque, K. (2010) · doi:10.2174/1996327001003010001 · Cited by 23 · see citing works
The Spleen Is an Ideal Site for Inducing Transplanted Islet Graft Expansion in Mice
Itoh, T., Nishinakamura, H., Kumano, K., Takahashi, H., & Kodama, S. (2017) · PLoS ONE · doi:10.1371/journal.pone.0170899 · Cited by 22
Resolution of Severe Atopic Dermatitis after Tacrolimus Withdrawal
Ponte, G., Baidal, D. A., Romanelli, P., Faradji, R. N., Poggioli, R., Cure, P., Froud, T., Selvaggi, G., Pileggi, A., Ricordi, C., et al. (2007) · Cell Transplantation · doi:10.3727/000000007783464524 · Cited by 24 · see citing works
Islet transplantation: steady progress and current challenges
Pileggi, A., Alejandro, R., & Ricordi, C. (2006) · Current Opinion in Organ Transplantation · doi:10.1097/01.mot.0000203878.00901.26 · Cited by 20 · see citing works
Comparison of Whole Organ Pancreas and Isolated Islet Transplantation for Type 1 Diabetes
Frank, A. M., Barker, C. F., & Markmann, J. F. (2005) · Advances in Surgery · doi:10.1016/j.yasu.2005.04.010 · Cited by 23 · see citing works
Self-citation
- Authors
- Markmann, J. F., Deng, S., Huang, X., Desai, N. M., Velidedeoglu, E. H., Lui, C., Frank, A., Markmann, E., Palanjian, M., Brayman, K., Wolf, B., Bell, E., Vitamaniuk, M., Doliba, N., Matschinsky, F., Barker, C. F., & Naji, A.
- Affiliations
- Hospital of the University of Pennsylvania (US)
- University of Pennsylvania (US)
- Children's Hospital of Philadelphia (US)
- University of Pennsylvania Health System (US)
- Corresponding author
- Markmann, James F.
- Deng, Shaoping
- Huang, Xiaolun
- Desai, Niraj M.
- Lui, Chengyang
- Frank, Adam
- Markmann, Eileen
- Palanjian, Maral
- Brayman, Kenneth
- Barker, Clyde F.
- Naji, Ali
- ORCID
- Venue
- Annals of Surgery
- Published
- 2003-06
- Volume
- 237
- Issue
- 6
- Pages
- 741-750
- ISSN
- 0003-4932 (ISSN-L)
- PMC
- PMC1514687
- OpenAlex
- W2324941813
- Cited by
- 175
- References
- 0
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 4 · 2023: 5 · 2021: 3 · 2019: 2 · 2018: 2 · 2017: 5 · 2016: 6 · 2015: 7 · 2014: 3 · 2013: 7 · 2012: 5
- FWCI
- 19.18
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Annals of Surgery (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Pennsylvania
- National Center for Research Resources (M01-RR-00040, 1U42 RR 16600, M01RR000040, U42RR016600)
- Topics
- Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- islet transplantation, insulin independence, type 1 diabetes, hypoglycemia, hypoglycemia unawareness, graft function, islet mass
- MeSH terms
- Adult, Blood Glucose, C-Peptide, Diabetes Mellitus, Type 1, Humans, Immunosuppressive Agents, Islets of Langerhans Transplantation, Recovery of Function
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