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Blood, Vol. 94 No. 1 (July 1), 1999:
pp. 368-371
A Clinical Trial of Retroviral-Mediated Transfer of a
rev-Responsive Element Decoy Gene Into CD34+
Cells From the Bone Marrow of Human Immunodeficiency Virus-1-Infected
Children
Donald B. Kohn,
Gerhard Bauer,
C. Robert Rice,
J.C. Rothschild,
Denise A. Carbonaro,
Penelope Valdez,
Qian-lin Hao,
Chen Zhou,
Ingrid Bahner,
Karen Kearns,
Kate Brody,
Sarah Fox,
Elizabeth Haden,
Kathy Wilson,
Cathy Salata,
Cathy Dolan,
Charles Wetter,
Estuardo Aguilar-Cordova, and
Joseph Church
From the Division of Research Immunology/Bone Marrow Transplantation
and the Division of Immunology/Allergy, Childrens Hospital Los Angeles,
the Department of Pediatrics, University of Southern California School
of Medicine; and Gene Vector Laboratories, Texas Children's Cancer
Center, Baylor College of Medicine, Houston, TX.
Genetic modification of hematopoietic stem cells with genes that
inhibit replication of human immunodeficiency virus-1 (HIV-1) could
lead to development of T lymphocytes and monocytic cells resistant to
HIV-1 infection after transplantation. We performed a clinical trial to
evaluate the safety and feasibility of this procedure, using bone
marrow from four HIV-1-infected pediatric subjects (ages 8 to 17 years). We obtained bone marrow, isolated CD34+ cells,
performed in vitro transduction with a retroviral vector carrying a
rev-responsive element (RRE) decoy gene, and reinfused the
cells into these subjects with no evidence of adverse effects. The
levels of gene-containing leukocytes in peripheral blood samples in the
1 year after gene transfer/cell infusion have been extremely low. These
observations support the potential of performing gene therapy for HIV-1
using hematopoietic cells, but emphasize the need for improved gene
transfer techniques.
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