ANTI-THYMOGLOBUMLIN, CYCLOSPORIN AND RAD IN ISLET TRANSPLANT

Project: Research project

Project Details

Description

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase I/II study designed to assess the safety and efficacy of sequential islet allotransplantation for the reestablishment of stable glycemic control in trype 1 diabetic recipients. A total of 6 patients with type 1 diabetes will be enrolled to receive two, possibly three transplants of islets from different donor pancreases. Potential candidates for islet allotransplantation will include patients age 18 and older with trype 1 diabetes. Induction immunotherapy for the first transplant will consist of anti-thymocyte globulin; basiliximab will be used for any subsequent transplants. Peritransplant anti-inflammatory treatment with etanercept will be given for each islet transplant. Maintenance immunosuppression will be with cyclosporine and RAD. It is felt that those patients in whom metabolic lability/instability, reduced awareness of hypoglycemia, poor glycemic control, and progressive secondary complications persist despite continued and intensive efforts made in close cooperation with their diabetes care team are particularly likely to have a favorable benefit/risk ratio. Adverse events, irrespective of their presumed relationship to the transplantation of allogeneic islets and/or protocol-regulated treatment products (concomitant therapy), will be monitored and recorded throughout the first year after the final islet transplant. The proportion of subjects who achieve insulin independence in the first year after the first, second or third allogeneic islet transplant will be assessed in a prospective trial. In the event insulin independence is not achieved within the first 6 weeks after islet transplantation, a second and possibly a third transplant will be performed. The proportion of single and sequential donor islet allograft recipients with full (insulin independence and HbA1c
StatusFinished
Effective start/end date12/1/06 → 11/30/07

Funding

  • National Center for Research Resources: $4,115.00

Access Project

Fingerprint

Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.
View full fingerprint

  • GCRC-General Clinical Research Center

    Dalmasso, A. A. P., Rocchini, A. P., Aldrich, N., Allen, S. S., Anderson, F. S., Macdonald, A. A. J., Dudek, A. A. Z., Matas, A. J., Leon, A. A. S., Sinaiko, A. A. R., Petryk, A., Moran, A. A. M., Bachanova, V. S., Berry, S. A., Kasiske, B. L., Van Ness, B. G., Hering, B. B. J., Karatekin, C., Torkelson, C. J., Earthman, C. P., Mariash, C. C. N., Verfaillie, C. C. M., Moldow, C. C., Nelson, C. A., Moldow, C. C. F., Chow, L. S., Gomez, C. M., Draheim, C. C., Kashtan, C., Jordan, C. C., Collins, T. C., Milla, C. C., Milla, C. C. E., Cheatham, C. C. L., Whitley, C. B., Fletcher, C. C. V., Kaiser, D. D., Johnson, D. D. Y., Duprez, D., Weisdorf, D. J., Canafax, D. D. M., Zelinskygoldman, D. D. A., Krason, D. D. A., Brown, D. D. M., Brown, D. D. R., Demerath, E. W., Treatjacobson, D. D. J., Neumark-sztainer, D. D. R., Donahue, C. B., Hunninghake, D. D. B., Dengel, D. R., Hatsukami, D. K., Pei, D. D., Gallaher, D. D., Hunter, D. D. J., Parks, E. E. J., Seaquist, E. R., Shapiro, E. G., Eugster, E. E. A., Giebink, G. G. S., Parry, G. G., Fulcher, G. G., Gaugler, J. E., Geller, M. A., Plotnikoff, G., Beilman, G. J., Gross, C. R., Metzger, G. G. J., Oz, G. G., Han, J. Y., Ibrahim, H. H. N., Hauff, L., Wynn, H. H., Wynnvezina, H. H., Hecht, S. S., Hongwanishkul, D., Balfour, H. H. H., Ikramuddin, S., Leppik, I. I. E., Baumgart, I. I., Redmon, J. J. B., Cloyd, J. J. C., White, J. J. G., Carey, J. R., Rank, J. J. M., Wozniak, J. J. R., Balfour, J. J., Billings, J. J. L., Slavin, J. J. L., Bloomfield, J. J., Bantle, J. J. P., Vuchetich, J. J. P., Day, J. J. W., Johnson, L. A. L., Dunitz, J. M., Pardo, J. V., Keenan, J. J., Gurney, J. J. G., Ahluwalia, J. J. S., Miller, J. J. B., Miller, J. J. S., Steinberger, J. J., Alavi, K. K., Daly, K. A., Thomas, K. K. M., Schmitz, K. K. H., Kehl, L., Skubitz, K. K. M., Lim, K. K. O., Baker, K. K. S., Khan, K. K. M., Kimberley, PT, T. J., Kirstein, M. N., Kurzer, M. S., Winters, K. K. C., Bushara, K. K. O., Allenberg, K. K., Sarafoglou, K. K., Stone, L. L. S., Downs, L. S., Carson, L. F., Burns, L. J., Halcon, L. L. L., Steffen, L. L. M., Lytle, L. A., Blumenthal, M. N., Hostetter, M. M., Hordinsky, M. K., Pereira, M. M. A., Mammel, M. C., Reding, M. M. T., Reicks, M. M., Hertz, M. I., Pylipow, M., Kennedy, M. M. B., Kushner, M. M., Kotlyar, M. M., Potegal, M., Steffes, M. W., Garwood, M. M. G., Mauer, M. M. S., Milev, P., Segall, M. M., Mooney, M. E., Mulrooney, D. A., Riches, M. M. L., Menge, M. M., Gunnar, M. M. R., Georgieff, M. M. K., Luciana, M. M., Al'absi, M. M. N., Gross, M. D., Nathan, B. M., Nazarian, S., Key, N. N., Nuttall, F. Q., Raymond, N. C., Key, N. N. S., Painter, P. L., Paller, M. S., Bauer, P. P. J., Faris, P. L., Yakshe, P. P., Orchard, P. J., Tuite, P. J., Pentel, P. R., Peterson, E. J., Petit, M. A., Polgreen, L. E., Jacobson, P. P. A., Regelmann, W. E., Miller, R. R., Gruetter, R., Remmel, R. P., Nagarajan, R. R., Grimm, R., Kempainen, R. R. R., Robertson, R. R. P., Schulz, S. S. C., Weisdorf, S. A., Schwarzenberg, S. J., Crow, S. S. J., Segal, B. M., Sibley, S., Specker, S. M., Smith, A. L., Sponheim, S. R., Straka, R. J., Raatz, S. S. K., Sutherland, D. E. R., Kumra, S., Cooley, S. S., Templeton, D. L., Terpstra, M. J., Therien, J. M., Sellers, T. T. A., Hostetter, T. T. H., Thomas, J. L., Whelan, T. T., Tracy, T. T. S., White, T., Schacker, T. W., Mathiowetz, V. G., Wagner, J. A., Walk, D., Warwick, W. W. J., Meller, W. H., Kennedy, W. W. R., Iacono, W. G., Yu, F., Balfour, H. H., Bantle, J. P., Barbosa, J. J., Blumenthal, M. N., Bouchard, T., Brown, D. M., Buchwald, H., Cavert, M. H., Chavers, B. M., Cloyd, J. C., Cohn, J. N., Daly, K., Day, J. W., Desnick, R. J., Dusenbery, K. E., Ferris, T. F., Fletcher, C. V., Frantz, I. D., Garwood, M. G., Goetz, F. C., Grimm, R. H., Gumnit, R. J., Halberg, F., Hatsukami, D. K., Hedemark, L. L., Hering, B. J., Hirsch, A. T., Hoogwerf, B. J., Hoogwerf, B. J., Hostetter, T. H., Hrushesky, W. J., Hrushesky, N. W. J., Hunninghake, D. B., Johnson, D. E., Kashtan, C. E., King, R. A., Klassen, A., Knopman, D. S., Kushner, M. G., Laine, D. C., Leon, A. S., Leppick, I. E., Leppik, I. E., Lippick, I., Luciana, M. M., Mariash, C. C. N., Matas, A. J., Mauer, M. S., Mauer, M. S., Messner, R. P., Michael, A. F., Miller, L. W., Miller, R. F., Miller, J. S., Mirkin, B. L., Mitchell, J. E., Moldrow, C. G., Monk, C. S., Moran, A. M., Oppenheimer, J. H., Page, A., Pereira, M. A., Pierpont, M. E. M., Raatz, S. K., Ralfour, H. H., Rank, J. M., Raymond, N. C., Redmon, J. B., Repka, T. L., Rhodus, N. L., Rice, K. L., Robertson, P. R., Roelofs, R., Schacker, T. W., Scheinman, J. I., Seaquist, E. R., Sharp, H. L., Sinaiko, A. R., Skubitz, K. M., Sofuoglu, M., Steffes, M. W., Steinberger, J., Sutherland, N. E. R., Sutherland, D. E. R., Taurog, J. D., Ulstrom, R. A., Vehe, R. K., Warwick, W. J., White, J. J. G., Whitley, C. B., Witkop, C. J., Young, T. L., Ziegler, R. J., Canafax, D. M., Crow, S. J., Eugster, E. A., Giebink, S. G., Jordan, C. M., Pentel, P. R., Sellers, T. A. & Verfaillie, C.

    National Center for Research Resources

    12/1/84 → 11/30/06

    Project: Research project