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Guidelines for the design and implementation of clinical studies in somatic cell therapy and gene therapy

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References

  1. Kessler DA, Siegel JP, Noguchi PD, Zoon KC et al (1993) Regulation of somatic cell therapy and gene therapy by the Food and Drug Administration (1993). N Engl J Med 329:1169

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  2. Food and Drug Administration (1993) Points to consider in human somatic cell therapy and c″te therapy. FDA docket no. 91N-0428 Federal register vol 58, no. 197, p 3248, docket no. 93N-09173

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Authors and Affiliations

  1. Abteilung Innere Medizin I, Hämatologie/Onkologie, Medizinische Universitätsklinik, Hugstetter Strasse 55, D-79106, Freiburg, Germany

    A. Lindemann, F. M. Rosenthal & R. Mertelsmann

  2. Schumannstrasse 97-99, D-40237, Düsseldorf, Germany

    S. Hase

  3. Universität Freiburg, Heinrich-von-Stephan-Strasse 25, D-79100, Freiburg, Germany

    P. Markmeyer

Authors
  1. A. Lindemann
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  2. F. M. Rosenthal
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  3. R. Mertelsmann
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  4. S. Hase
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  5. P. Markmeyer
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Lindemann, A., Rosenthal, F.M., Mertelsmann, R. et al. Guidelines for the design and implementation of clinical studies in somatic cell therapy and gene therapy. J Mol Med 73, 207–211 (1995). https://doi.org/10.1007/BF00188142

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  • DOI: https://doi.org/10.1007/BF00188142

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