Abstract
The transplantation of living cells and tissues to restore function and/or provide therapeutic molecules has been an active and ongoing area of research interest for over 25 years. Several of these potential therapies have reached initial clinical trials, and it is likely that applications will continue to expand, and that novel and improved approaches will be explored over the next several years. In the past, many of these experimental approaches were tested in early clinical trials without the oversight of regulatory agencies such as the Food and Drug Administration. However, as novel cellular therapies move from preclinical laboratory findings to the clinical arena, researchers and regulators face new and continually evolving issues and uncertainties involving long-term safety and efficacy. Using adrenal medullary transplantation in the spinal cord for pain as an example, this review presents an overview of past and current regulatory guidelines for moving these promising, novel cellular transplantation therapies from the laboratory to the human.
| Original language | English |
|---|---|
| Pages (from-to) | 71-79 |
| Number of pages | 9 |
| Journal | Journal of Rehabilitation Research and Development |
| Volume | 40 |
| Issue number | 4 SUPPL. 1 |
| State | Published - Jul 1 2003 |
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Keywords
- Cell transplantation
- Center for Biologics Evaluation and Research (CBER)
- Chromaffin cells
- Food and Drug Administration (FDA)
- Pain
- Regulatory agencies
- Spinal cord injury
ASJC Scopus subject areas
- Rehabilitation
- Health Professions(all)
- Engineering(all)
Cite this
Cellular therapies for spinal cord injury : What will the FDA need to approve moving from the laboratory to the human? / Sagen, Jacqueline.
In: Journal of Rehabilitation Research and Development, Vol. 40, No. 4 SUPPL. 1, 01.07.2003, p. 71-79.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Cellular therapies for spinal cord injury
T2 - What will the FDA need to approve moving from the laboratory to the human?
AU - Sagen, Jacqueline
PY - 2003/7/1
Y1 - 2003/7/1
N2 - The transplantation of living cells and tissues to restore function and/or provide therapeutic molecules has been an active and ongoing area of research interest for over 25 years. Several of these potential therapies have reached initial clinical trials, and it is likely that applications will continue to expand, and that novel and improved approaches will be explored over the next several years. In the past, many of these experimental approaches were tested in early clinical trials without the oversight of regulatory agencies such as the Food and Drug Administration. However, as novel cellular therapies move from preclinical laboratory findings to the clinical arena, researchers and regulators face new and continually evolving issues and uncertainties involving long-term safety and efficacy. Using adrenal medullary transplantation in the spinal cord for pain as an example, this review presents an overview of past and current regulatory guidelines for moving these promising, novel cellular transplantation therapies from the laboratory to the human.
AB - The transplantation of living cells and tissues to restore function and/or provide therapeutic molecules has been an active and ongoing area of research interest for over 25 years. Several of these potential therapies have reached initial clinical trials, and it is likely that applications will continue to expand, and that novel and improved approaches will be explored over the next several years. In the past, many of these experimental approaches were tested in early clinical trials without the oversight of regulatory agencies such as the Food and Drug Administration. However, as novel cellular therapies move from preclinical laboratory findings to the clinical arena, researchers and regulators face new and continually evolving issues and uncertainties involving long-term safety and efficacy. Using adrenal medullary transplantation in the spinal cord for pain as an example, this review presents an overview of past and current regulatory guidelines for moving these promising, novel cellular transplantation therapies from the laboratory to the human.
KW - Cell transplantation
KW - Center for Biologics Evaluation and Research (CBER)
KW - Chromaffin cells
KW - Food and Drug Administration (FDA)
KW - Pain
KW - Regulatory agencies
KW - Spinal cord injury
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UR - http://www.scopus.com/inward/citedby.url?scp=0043233331&partnerID=8YFLogxK
M3 - Article
C2 - 15077651
AN - SCOPUS:0043233331
VL - 40
SP - 71
EP - 79
JO - Journal of rehabilitation R&D
JF - Journal of rehabilitation R&D
SN - 0748-7711
IS - 4 SUPPL. 1
ER -