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In Reply: Drs Ross and Philipson argue that our study of stem cell transplantation was unethical because (1) research involving pediatric participants is unethical unless it will promote the health of children and the research cannot be performed in adults, according to the Declaration of Helsinki, and (2) age-matched controls were needed to determine the extent of the benefits and adverse effects of the treatment.

The study was approved by local and national institutional review boards, which imposed no lower limits for patient age (0-35 years). Nevertheless, we included only patients older than 13 years. All patients and 1 of their parents signed the informed consent. The first minor patient was included only after 3 adult patients had undergone transplantation, 2 of them successfully.

We note that other trials of chronic^1-3 or acute^4-5 immunosuppression in type 1 DM have included minor patients. Hematopoietic stem cell transplantation has been performed for . . . [Full Text of this Article]

Julio C. Voltarelli, MD, PhD
jcvoltar@fmrp.usp.br

Carlos E. B. Couri, MD, PhD; Ana B. P. L. Stracieri, MD, PhD; Maria C. Oliveira, MD, MSc; Daniela A. Moraes, MD; Fabiano Pieroni, MD, PhD; Marina Coutinho, MD, MSc; Kelen C. R. Malmegrim, PhD; Maria C. Foss-Freitas, MD, PhD; Belinda P. Simões, MD, PhD; Milton C. Foss, MD, PhD
Department of Clinical Medicine
School of Medicine of Ribeirão Preto
University of São Paulo
Ribeirão Preto, Brazil

Elizabeth Squiers, MD
Y's Therapeutics Inc
Burlingame, California

Richard K. Burt, MD
Division of Immunotherapy
Northwestern University
Chicago, Illinois

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RELATED LETTER

Ethics of Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus
Lainie Friedman Ross and Louis H. Philipson
JAMA. 2007;298(3):285.
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Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus
Júlio C. Voltarelli, Carlos E. B. Couri, Ana B. P. L. Stracieri, Maria C. Oliveira, Daniela A. Moraes, Fabiano Pieroni, Marina Coutinho, Kelen C. R. Malmegrim, Maria C. Foss-Freitas, Belinda P. Simões, Milton C. Foss, Elizabeth Squiers, and Richard K. Burt
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