Development of a human pancreatic islet-transplant program through a collaborative relationship with a remote islet-isolation center

Goss, John A.; Goodpastor, Sarah E.; Brunicardi, F. Charles; Barth, M.; Soltes, George D.; Garber, Alan J.; Hamilton, Dale J.; Alejandro, Rodolfo; Ricordi, Camillo

doi:10.1097/01.tp.0000100397.86756.a3

Cited by 75 publications

(51 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Currently, a vast majority of islet transplant procedures is performed in the ITA setting (6,(8)(9)(10)(11). This series shows that islet transplantation can be done in the IAK setting with equal efficacy and safety.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Sequential Kidney/Islet Transplantation: Efficacy and Safety Assessment of a Steroid-Free Immunosuppression Protocol

Toso

Baertschiger

Morel

et al. 2006

American Journal of Transplantation

View full text Add to dashboard Cite

The aim of this study was to assess the efficiency and safety of the Edmonton immunosuppression protocol in recipients of islet-after-kidney (IAK) grafts. Fifteen islet infusions were administered to 8 patients with type 1 diabetes and a functioning kidney graft. Immunosuppression was switched on the day of transplantation to a regimen associating sirolimus-tacrolimus-daclizumab. Insulinindependence was achieved in all patients for at least 3 months, with an actual rate of 71% at 1 year after transplantation (5 of 7 patients). After 24-month mean follow-up, five have ongoing insulin independence, 11-34 months after transplantation, with normal HbA1c, fructosamine and mean amplitude of glycemic excursions (MAGE) values. Results of arginine-stimulation tests improved over time, mostly after the second islet infusion. Severe adverse events included bleeding after percutaneous portal access (n = 2), severe pneumonia attributed to sirolimus toxicity (n = 1), kidney graft loss after immunosuppression discontinuation (n = 1), reversible humoral kidney rejection (n = 1) and fever of unknown origin (n = 1). These data indicate that the Edmonton approach can be successfully applied to the IAK setting. This procedure is associated with significant side effects and only patients with stable function of the kidney graft should be considered. The net harm versus benefit has not yet been established and will require further studies with larger numbers of enrolled subjects.

show abstract

Section: Discussionmentioning

confidence: 99%

“…In the steroid-free era, the effort has been concentrated on islet transplant alone (ITA), in nonuremic patients with metabolic lability (3,(6)(7)(8)(9)(10)(11). No study has specifically addressed the impact of a sirolimus-based, steroid-free immunosuppression regimen in a series of islet-after-kidney (IAK) transplantation so far.…”

Section: Introductionmentioning

confidence: 99%

Sequential Kidney/Islet Transplantation: Efficacy and Safety Assessment of a Steroid-Free Immunosuppression Protocol

Toso

Baertschiger

Morel

et al. 2006

American Journal of Transplantation

View full text Add to dashboard Cite

show abstract

“…In an attempt to standardize shipping procedures, we have developed a protocol based on the use of gas-permeable bags (GPBs) that has been utilized in the ongoing clinical trials between the UM-ICPC and remote CITPs (6,7). Similar protocols have been recently adopted at other centers (14).…”

Section: Introductionmentioning

confidence: 99%

“…Recent trials have shown that the center's experience in islet isolation and patient management plays a critical role in the success rate of the CIT program (CITP) (1)(2)(3)(4)(5). The use of regional Islet Cell Processing Centers (ICPC), isolating islets that are sent to remote CITP, has proven successful in recent years both in Europe and United States (6)(7)(8)(9). The concept of ICPC-CITP networks may allow for better utilization of donor pancreata and to obtain a steady supply of high-quality islets, while containing the overall costs of establishing a new ICPC.…”

Section: Introductionmentioning

confidence: 99%

“…No detail is available on the islet shipping protocol utilized by the Minneapolis-Seattle collaboration (12). In recent years, we have established partnerships between the University of Miami ICPC (UM-ICPC) and distant CITPs where islets are shipped for transplantation by charter jet (6,7,13). In compliance with Food and Drug Administration (FDA) regulations for cellular therapies, islet cell products are assessed before (at the ICPC) and after shipment (at the remote CITP) to confirm that adequacy of islets (namely, quality and mass) for transplantation ( Figure 1).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Shipment of Human Islets for Transplantation

Ichii¹,

Sakuma²,

Pileggi³

et al. 2007

American Journal of Transplantation

105

View full text Add to dashboard Cite

The use of regional human islet cell processing centers (ICPC) supporting distant clinical islet transplantation programs (CITP) has proven successful in recent clinical trials. Standardization of islet shipping protocols is needed to preserve cell product identity, quantity, quality and sterility, and to meet criteria for transplantation. We evaluated the use of gas-permeable bags for human islet preparation shipment from a single ICPC to two remote CITPs. Product release tests (counts, purity, viability, sterility and potency) were performed at both centers using identical protocols to determine adequacy for transplantation. Thirty-five islet preparations were shipped either immediately after isolation (n = 20) or following culture (n = 15). Islet recovery rate after shipment was higher in cultured preparations, when compared to those not cultured (91.2 ± 4.9% vs. 72.9 ± 4.7%, respectively; p < 0.05), though the overall recovery rate based on isolation and pretransplant counts was comparable (72.9 ± 4.7% vs. 70.4 ± 3.5%, respectively; p = N.S.). All preparations met product release criteria for transplantation. Additional experiments showed that gas-permeable bags led to improved recovery and potency, when compared to 50-mL conical tubes or to non-gas-permeable bags for shipment. Collectively, our data demonstrate that the use of gas-permeable bags is efficient for clinicalgrade and should be preferred also for the shipment of research-grade islet preparations.

show abstract

Human Pancreatic Islets and Diabetes Research

Kaddis

Olack²,

Sowinski³

et al. 2009

JAMA

View full text Add to dashboard Cite

Development of a human pancreatic islet-transplant program through a collaborative relationship with a remote islet-isolation center

Abstract: Collaboration with an experienced PIT/PII center allows developing programs to focus on patient safety and care, prudent use of pancreata, and consolidates PII expertise and experience.

Cited by 75 publications

References 4 publications

Sequential Kidney/Islet Transplantation: Efficacy and Safety Assessment of a Steroid-Free Immunosuppression Protocol

Sequential Kidney/Islet Transplantation: Efficacy and Safety Assessment of a Steroid-Free Immunosuppression Protocol

Shipment of Human Islets for Transplantation

Human Pancreatic Islets and Diabetes Research

Contact Info

Product

Resources

About