Biosafety monitoring of patients receiving intracerebral injections of murine retroviral vector producer cells

Human Gene Therapy

Volumn 9, Issue 8, 1998, Pages 1165-1172

  Long, Zhifeng ^a   Li, Lie Ping ^a   Grooms, Tracey ^a   Lockey, Christopher ^a   Nader, Kellie ^a   Mychkovsky, Ihor ^a   Mueller, Stephen ^a   Burimski, Irina ^a   Ryan, Patricia ^a   Kikuchi, Gary ^a   Ennist, David ^a   Marcus, Stephen ^a   Otto, Edward ^a   McGarrity, Gerard ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CORE PROTEIN; VIRUS PROTEIN;

ADULT; ARTICLE; BRAIN CANCER; DNA SEQUENCE; GENE THERAPY; HUMAN; HUMORAL IMMUNITY; INTRACEREBRAL DRUG ADMINISTRATION; LEUKOCYTE; MAJOR CLINICAL STUDY; PATIENT MONITORING; POLYMERASE CHAIN REACTION; RETROVIRUS;

MURINAE; UNIDENTIFIED RETROVIRUS;

EID: 17344372848     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/hum.1998.9.8-1165     Document Type: Article

References (16)

1. ANDERSON, W.F. (1992). Human gene therapy. Science 256, 808-813.
2. ANDERSON, W.F., MCGARRITY, G.J., and MOEN, R.C. (1993). Report to NIH recombinant DNA advisory committee on murine replication-competent retrovirus (RCR) assays. Hum. Gene Ther. 4, 311-321.
3. BI, W.L., PARYSEK, L.M., WARNICK, R., and STAMBROOK, P.J. (1993). In vitro evidence that metabolic cooperation is responsible for the bystander effect observed with HSV Tk retroviral gene therapy. Hum. Gene Ther. 4, 725-731.
4. Center of Biologies Evaluation and Research (CBER, FDA). (1993). Letter to Sponsor of an IND Using a Retroviral Vector (September 20).
5. CORNETTA, K., MOEN, R.C., CULVER K., MORGAN, R.A., MCLACHLIN, J.R., STURM, S., SELEGUE, J., LONDON, W., BLAESE, R.M., and ANDERSON, W.F. (1990). Amphotropic murine leukemia retrovirus is not an acute pathogen for primates. Hum. Gene Ther. 1, 15-30.
6. CORNETTA, K., MORGAN, R.A., GILLIO, A., STURM, S., BALTRUCKI, L., O'REILLY, R., and ANDERSON, W.F. (1991). No retroviremia or pathology in long-term follow-up of monkeys exposed to a murine amphotropic retrovirus. Hum. Gene Ther. 2, 215-219.
7. CULVER, K.W., RAM, Z., WALLBRIDGE, S., ISHII, H., OLDFIELD, E.H., and BLAESE, R.M. (1992). In vivo gene transfer with retroviral vector-producer cells for treatment of experimental brain tumors. Science 256, 1550-1552.
8. CULVER, K.W., VAN GILDER, J., LINK, C., CARLSTROM, T., BUROKER, T., YUH, W., KOCH, K., SCHABOLD, K., DOORNBAS, S., WETJEN, B., and BLAESE, M. (1994). Gene therapy for the treatment of malignant brain tumors with in vivo tumor transduction with the herpes simplex thymidine kinase gene/ganciclovir system. Hum. Gene Ther. 5, 343-379.
9. DONAHUE, R.E., KESSLER, S.W., BODINE, D., MCDONAGH, K., BYME, E., RAFFIELD, M., MOEN, R., BACHER, J., ZSEBO, K.M., and NIENHUIS, A.W. (1992). Helper virus induced T cell lymphoma in nonhuman primates after retroviral mediated gene transfer. J. Exp. Med. 176, 1125-1135.
10. FREEMAN, S.M., ABBOUD, C.N., WHARTENBY, K.A., et al. (1993). The bystander effect: Tumor regression when a fraction of the tumor mass is genetically modified. Cancer Res. 53, 5274-5283.
11. GOLUMBEK, P.T., HAMZEH, F.M., JAFFEE, E.M., LEVITSKY, H., LIETMAN, P.S., and PARDOLL, D.M. (1992). Herpes simplex-1 virus thymidine kinase gene is unable to completely eliminate live, nonimmunogenic tumor cell vaccines. J. Immunother. 12, 224-230.
12. HAAPALA, D.K., ROBEY, W.G., OROSZLAN, S.D., and TSAI, W.P. (1985). Isolation from cats of an endogenous type C virus with a novel envelope glycoprotein. J. Virol. 53, 827-833.
13. KATO, K., YOSHIDA, J., MIZUNO, M., SUGITA, K., and EMI, N. (1994). Retroviral transfer of herpes simplex thymidine kinase into glioma cells targeting of ganciclovir cytotoxic effect. Neurol. Med. Chir. (Tokyo) 34, 339-344.
14. TEMIN, H.M. (1990). Safety considerations in somatic gene therapy of human disease with retrovirus vectors. Hum. Gene Ther. 1, 111-123.
15. WILSON, C.A., NG, T.-H., and MILLER, A.E. (1997). Evaluation of recommendations for replication-competent retovirus testing associated with the use of retroviral vectors. Hum. Gene Ther. 8, 869-874.
16. WU, J., CANO, W., MEYLAERTS, S., QI, P., VIRONIS, F., and CHERINGTON, V. (1994). Bystandard tumoricidal effect in the treatment of experimental brain tumors. Neurosurgery 35, 1094-1102.