The state of affairs of allogenic islet transplantation. William Bennet MD, PhD Fellow Division of Transplant Surgery UCHSC
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1 The state of affairs of allogenic islet transplantation William Bennet MD, PhD Fellow Division of Transplant Surgery UCHSC
2 Global epidemiology of Diabetes Mellitus IDDM NIDDM Amos et al. The rising global burden of diabetes and it s complications: estimates and projections to the year Diabetic Medicine 1997; 14 (Suppl 5)
3 (Rhesus monkeys)
4 Insulin independence 1 year after pancreas- vs. islet transplantation ~ 80 % 8 % Bennet, 1999
5 Comparison between pancreas and islet allotransplantation Immunological barrier Autoimmune barrier Immunosuppression Transplantation technique Pancreas Same Same Same Re-establishment of circulation Islet Same Same Same Intraportal
6 Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using a Glucocorticoid-Free Immunosuppressive Regimen Volume 343: July 27, 2000 Number 4 A.M. James Shapiro, M.B., B.S., Jonathan R.T. Lakey, Ph.D., Edmond A. Ryan, M.D., Gregory S. Korbutt, Ph.D., Ellen Toth, M.D., Garth L. Warnock, M.D., Norman M. Kneteman, M.D., and Ray V. Rajotte, Ph.D.
7 NORTH AMERICA Edmonton (76) Miami (30) Minneapolis (20) Vancouver (12) U Penn, (12) Houston (11) Harvard, Boston (10) Birmingham AL (3) Northwestern, (8) St. Louis (8) U Illinois (5) Emory, Atlanta (7) Cincinnati (6) NIH (6) Seattle (6) City of Hope CA (5) Memphis (3) U Maryland (2) Columbia NY (2) U Mass (2) UC San Francisco (2) Carolina Med Center (1) Cornell NY (1) Denver (1) Islet Transplant Activity ( ) >50 Institutions: > 500 patients Santiago Chili (1) San Paulo (3) Buenos Aires (11) EUROPE SOUTH AMERICA ASIA & AUSTRALIA Sydney (6) Kyoto (6) Tokyo (1) Seoul (2) Chiba (1) Harbin (1) Shanghai (1)
8 One Year Insulin Independence Completed Transplants (Kaplan-Meier) EDMONTON MIAMI MINNESOTA (n=118) ~ 80% mean overall one-year insulin independence
9 Five Year Outcomes of Fresh vs Cultured Islets Insulin Independence 100 Insulin Independence (%) % FRESH (n=28) Time in Months Post First Transplant 8% CULTURED (n=25) Log Rank: 5.52 P= 0.02 A.M. James Shapiro 2004
10 Allo vs. auto transplantation
11 A dose finding study in humans x10 3 IEQ / kg BW or Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using a Glucocorticoid-Free Immunosuppressive Regimen Volume 343: July 27, 2000 Number IEQ / kg BW x pre-tx ins. req. A.M. James Shapiro, M.B., B.S., Jonathan R.T. Lakey, Ph.D., Edmond A. Ryan, M.D., Gregory S. Korbutt, Ph.D., Ellen Toth, M.D., Garth L. Warnock, M.D., Norman M. Kneteman, M.D., and Ray V. Rajotte, Ph.D.
12 220 IEQ / kg BW x pre-tx ins. req. Obtained by matching small recipients & large donors
13 Islets IEQ islets IEQ (IEQ = a standardized islet with a diameter of 150 µm The endocrine pancreas Islet diameter Number of islets % of total % of total (μm) number of islet islet volume < % % % % % 15 > % 6.3 Total islet volume 1 ml, islets (> 20 µ m) 20% 80%
14 Cell Transplant 1998; 7: 489. Insulin in = Insulin out
15 Islet isolation improvements? Almost nothing to gain by spending money and efforts on getting more islets from each pancreas Quality not numbers!
16 So why do allogenic islets fail to thrive long term?
17 ISLET TRANSPLANTATION IN RODENTS Davalli AM et al, Day 1: Necrotic cores Diabetes 19: ,1996 Conclusion from this and other studies is that only about % of the transplanted islets survive the first few weeks. Day 3: Necrosis and cell infiltration increases Day 7: Remodelling Day 14: Graft is more compact and better vascularized
18 DIABETES, VOL. 48, OCTOBER 1999,
19 Islet of Langerhans Vascular Endothelium x 850 x 220 Bennet, 1999
20 Human islet morphology after 60 min exposure to human blood in vitro (CD11b, x200) Bennet, 1999
21 TAT (µg/l) C-peptide (pmol/l) Clinical islet transplantation Coagulation/IBMIR Islet infusion ßcell destruction Lisa Moberg 2002
22 IBMIR IN CLINICAL ISLET TRANSPLANTATION No patients with both high C-peptide and TAT levels Nordic network Edmonton
23 Tissue Factor
24 Normal islets heparinized islets
25 Surface heparinized pig islets are protected from IBMIR after intraportal transplantation Time (min Time (min Control SNL
26
27 ß cell exhaustion / glucose toxicity
28 Diabetes 2005, 54:
29 Allotransplantation Pancreas Summary Islets IBMIR Acute cellular rejection Physiological adaptation Clinical islet transplantation Donor management Optimized culture conditions (Nic) ifviia / LMW-DS Surface heparinization Immunosuppressive drugs Glucose toxicity / ß cell exhaustion
30 Challenges for the future (next 5 years) A. No special islet donor criteria. B. Improve islet quality, less focus on islet number (donor & isolation) C. Improve islet culture and shipment D. Focus on metabolic control, not insulin independence (combine islet tx 1:1 with long acting insulin) E. More tolerable immunosuppressive regimes (carefully controlled randomized clinical trials) F. Islet tx can only develop into a treatment for uncomplicated type 1 diabetes if E can be achieved (even if an unlimited source of ß cells was available)
31 With the large number of IDDM patients and the lack of donor pancreata the future of islet transplantation is likely to be in xenogenic porcine islet transplantation
32
33 ß cell volume (% of normal) Reserve capacity maintained in healthy persons ß cell volume required to maintain normal IVGTT <5 ß cell volume required to obtain insulin independence Type 1 Diabetes Time
34 Enhanced outcome Several (obese) donors Small recipients Improve islet isolation Enhance engraftment
35 Decay in Islet Function over time Undiagnosed acute rejection Chronic allograft rejection Recurrent Autoimmunity cf. pancreas tx & clinical course Failure of islet regeneration Drug toxicity ß cell exhaustion (glucose toxicity) of an isletgraft just able to maintain normoglycemia Modified from an original by A.M. James Shapiro 2004
36 Clinical islet transplantation Success is dependent on surviving islet mass Islet morbidity in during culture Loss early after transplantation (inflammation) Loss during cellular rejection Absence of islet toxic immunosuppressive regimes
37
38 Our studies suggest that both human (allogenic) as well as porcine (xenogenic) islets transplanted via the portal vein into the liver will be damaged shortly after transplantation by a strong inflammatory reaction. This inflammatory reaction has not been described in detail previously and therefore lacks a descriptive name. We have chosen to name it an: Instant Blood Mediated Inflammatory Reaction IBMIR
39
40 Disseminated intravascular coagulation and portal hypertension following pancreatic islet autotransplantation Mehigan, Acute portal D. G., hypertension et al., Anns Surg, and disseminated 191: , 1980 intravascular coagulation following pancreatic islet autotransplantation after subtotal pancreatectomy Mittal Portal V.K., vein et thrombosis al., Transplantation after transplantation,31: 302-4, 1981 of partially purified pancreatic islets in a combined human liver/islet allograft. Shapiro A., et al., Transplantation,59: , 1995 Fatal disseminated intravascular coagulation after autologous islet transplantation Froberg M.K.., et al., Human pathology, 28: , 1997
41 Induced expression of inflammatory mediators in human islets Diseased donor Brain death Ischemia Islet isolation Culture conditions
42 Expression of inflammation-related genes in human islets TF induce coagulation & inflammation 450 MCP-1 powerful chemoattractant for leukocytes Day Day 2 Day Day 7 Day Interleukin-6 precursor (IL-6) Interleukin-8 precursor (IL-8) Monocyte chemotactic protein 1 precursor T-cell-specific rantes protein precursor Thymosin beta-10 (TMSB10; THYB10) Vascular endothelial groth factor precurcor (VEGF) Interleukin-11 (IL-11) Interleukin-2 receptor alpha subunit precursor ( Delta-like protein precursor Macrophage migration inhibitory factor (MIF) N-sam; fibroblast growth factor receptor1 precursor (FGFR1) Prohibitin (PHB) Insulin-like growth factor binding protein 2 (IGFBP2 U Johansson et al BBRC Epithelial discoidin domain receptor 1 precursor (EDDR1; DDR1)
43 Five Year Kaplan-Meier Survival Curves (Insulin Independence from time of first transplant) Fresh (N=25) Cultured (N=22) Survival (%) Log Rank Statistic: 1.6 P-Value: % 24% Time in Months Post First Transplant A.M. James Shapiro 2004
44 Islet activated coagulation Tissue Factor on the islets activates the coagulation cascade via FVII Thrombosis
45 Human islet morphology after 5 min exposure to human blood in vitro (CD41, x200) Before IBMIR (H&E, x400) (CD11b, x200) (P-selectin, x200) Bennet, 1999
46
47 Diabetes 2005, 54:
48
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