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

1995 ◽  
Vol 73 (4) ◽  
Author(s):  
A. Lindemann ◽  
F.M. Rosenthal ◽  
R. Mertelsmann ◽  
S. Hase ◽  
P. Markmeyer
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Somatic Cell ◽  
Clinical Studies ◽  
Design And Implementation ◽  
Somatic Cell Therapy

Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration

1993 ◽  
Vol 329 (16) ◽  
pp. 1169-1173 ◽  
Author(s):  
David A. Kessler ◽  
Jay P. Siegel ◽  
Philip D. Noguchi ◽  
Kathryn C. Zoon ◽  
Karyn L. Feiden ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Cell Therapy ◽  
Somatic Cell ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Somatic Cell Therapy

scholarly journals Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Dianne Nicol ◽  
Lisa Eckstein ◽  
Michael Morrison ◽  
Jacob S. Sherkow ◽  
Margaret Otlowski ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Somatic Cell ◽  
Somatic Cell Therapy

Specific requirements for somatic cell therapy medicinal products and tissue engineered products

2015 ◽  
Vol 17 (1,2) ◽  
pp. 271-277
Author(s):  
Rosa M. Hernández Martín ◽  
Eduardo L. Mariño Hernández ◽  
José Luis Pedraz Muñoz ◽  
Antonio M. Rabasco Álvarez
Keyword(s):  
Cell Therapy ◽  
Somatic Cell ◽  
Medicinal Products ◽  
Somatic Cell Therapy

Towards the Generation of Patient-Specific Pluripotent Stem Cells for Combined Gene and Cell Therapy of Hematologic Disorders

Hematology ◽  
2007 ◽  
Vol 2007 (1) ◽  
pp. 17-22 ◽  
Author(s):  
George Q. Daley
Keyword(s):  
Stem Cells ◽  
Gene Therapy ◽  
Cell Therapy ◽  
Somatic Cell ◽  
Pluripotent Stem Cells ◽  
Tissue Transplantation ◽  
Model Systems ◽  
Patient Specific ◽  
Gene Repair ◽  
Hematopoietic Stem

Abstract Hematopoietic stem cell transplantation (HSCT) has proven successful for the treatment of a host of genetic and malignant diseases of the blood, but immune barriers to allogeneic tissue transplantation have hindered wider application. Likewise, gene therapy now appears effective in the treatment of various forms of immune deficiency, and yet insertional mutagenesis from viral gene transfer has raised safety concerns. One strategy for addressing the limitations of both gene therapy and allogeneic transplantation entails the creation of pluripotent stem cells from a patient’s own somatic cells, thereby enabling precise in situ gene repair via homologous recombination in cultured cells, followed by autologous tissue transplantation. In murine model systems, the methods of somatic cell nuclear transfer, parthenogenesis, and direct somatic cell reprogramming with defined genetic factors have been used to generate pluripotent stem cells, and initial efforts at therapeutic gene repair and tissue transplantation suggest that the technology is feasible. Generating patient-specific autologous pluripotent stem cells provides an opportunity to combine gene therapy with autologous cell therapy to treat a host of human conditions. However, a number of technical hurdles must be overcome before therapies based on pluripotent human stem cells will appear in the clinic.

Characterization of a Human Cell Clone Expressing Cytochrome P450 for Safe Use in Human Somatic Cell Therapy

1999 ◽  
Vol 880 (1 CELL AND MOLE) ◽  
pp. 326-336 ◽  
Author(s):  
WALTER H. GUNZBURG ◽  
PETER KARLE ◽  
RENATE RENZ ◽  
BRIAN SALMONS ◽  
MATTHIAS RENNER
Keyword(s):  
Cytochrome P450 ◽  
Cell Therapy ◽  
Somatic Cell ◽  
Human Cell ◽  
Cell Clone ◽  
Human Somatic Cell ◽  
Somatic Cell Therapy
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