Author Contributions: Dr Hering had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analyses.
Study concept and design: Hering, Kandaswamy,
Eckman, Matsumoto, Hunter, Sutherland.
Acquisition of data: Hering, Kandaswamy, Ansite,
Nakano, Sawada, Matsumoto, Ihm, Zhang, Parkey, Hunter.
Analysis and interpretation of data: Hering,
Drafting of the manuscript: Hering, Ansite,
Eckman, Nakano, Matsumoto, Ihm, Zhang.
Critical revision of the manuscript for important
intellectual content: Hering, Kandaswamy, Eckman, Sawada, Parkey, Hunter,
Statistical analysis: Sawada, Ihm.
Obtained funding: Hering.
Administrative, technical, or material support:
Hering, Kandaswamy, Ansite, Eckman, Nakano, Matsumoto, Zhang.
Study supervision: Hering, Sutherland.
All authors contributed to the preparation of the report.
Financial Disclosures: None reported.
Funding/Support: This study was supported by
grants from Roche Laboratories Inc (RO49272), the National Center for Research
Resources, National Institutes of Health (MO1-RR00400 and U42 RR016598-01),
and the Juvenile Diabetes Research Foundation (JDRF #4-1999-841). SangStat
provided rabbit anti-thymocyte globulin. Wyeth-Ayerst supplied sirolimus.
Role of the Sponsors: The sponsors had no role
in the design or conduct of the study; the collection, management, analysis,
and interpretation of the data; or the preparation, review, or approval of
Acknowledgment: We are indebted to Kathy Duderstadt,
Kathy Hodges, and Carrie Gibson for their invaluable contributions as study
nurse coordinators; to the staff members of the General Clinical Research
Center for excellent patient care; to Jeremy Oberbroeckling for his technical
expertise in the islet isolation laboratory; and to Robin Jevne, PhD, and
Dylan Zylla for data analysis and presentation. We appreciate the critical
manuscript review by Klearchos Papas, PhD. We are grateful to Richard Bergenstal,
MD, David Kendall, MD, and Lisa Fish, MD, for verifying participant eligibility;
to George Eisenbarth, MD, PhD, for measuring autoantibodies; and to Edmond
Ryan, MD, for assisting with metabolic studies. We thank LifeSource, other
organ procurement organizations, and Julianne Zabloski for their efforts in
pancreas procurement and Deborah Butterfield of Diabetes Portal for assistance
in participant recruitment. We thank Mary Knatterud, PhD, for editing the