Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Cell transplantation and Federal regulation

P D Noguchi1

  • 1Division of Cellular and Gene Therapies, Food and Drug Administration, Rockville, MD 20852-1448, USA.

Cell Transplantation
|July 1, 1995
PubMed
Summary

Federal regulation of tissues and organs focuses on safety. Recent guidance for manufactured somatic cell therapies includes efficacy, similar to cell transplantation, prompting an exploration of these regulatory relationships.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

IL-13 induces phosphorylation and activation of JAK2 Janus kinase in human colon carcinoma cell lines: similarities between IL-4 and IL-13 signaling.

Journal of immunology (Baltimore, Md. : 1950)·1996
Same author

From Jim to gene and beyond: an odyssey of biologics regulation.

Food and drug law journal·1996
Same author

Receptors for interleukin (IL)-4 do not associate with the common gamma chain, and IL-4 induces the phosphorylation of JAK2 tyrosine kinase in human colon carcinoma cells.

The Journal of biological chemistry·1995
Same author

Xenotransplantation and xenogeneic infections.

The New England journal of medicine·1995
Same author

Regulatory review of cellular and gene therapies: an overview of the process.

Transfusion science·1994
Same author

Regulation of somatic-cell therapy and gene therapy by the food and drug administration.

The New England journal of medicine·1993

Area of Science:

  • Biomedical Regulation
  • Cellular Therapy Oversight
  • Transplantation Science

Background:

  • Federal regulation of tissues and organs has historically prioritized material safety.
  • The Food and Drug Administration (FDA) has recently issued guidance for manufactured somatic cell therapies, introducing efficacy requirements.
  • Cell transplantation shares similarities with somatic cell therapies, necessitating a review of regulatory frameworks.

Purpose of the Study:

  • To explore the regulatory relationships between cell transplantation and somatic cell therapies.
  • To analyze the evolving landscape of federal regulation for cellular products.
  • To identify commonalities in safety and efficacy considerations for transplanted cells and manufactured cell therapies.

Main Methods:

  • Comparative analysis of existing FDA guidance documents.
  • Review of regulatory frameworks for tissue, organ, and cell-based products.
  • Exploration of legal and scientific precedents in regenerative medicine regulation.

Main Results:

  • Somatic cell therapies face both safety and efficacy scrutiny.
  • Cell transplantation may increasingly be subject to similar efficacy standards.
  • Regulatory pathways for cellular products are converging.

Conclusions:

  • The regulatory approach to cell transplantation is evolving towards encompassing efficacy.
  • Understanding the parallels between somatic cell therapies and cell transplantation is crucial for future regulatory harmonization.
  • Ensuring both safety and efficacy is paramount for advancing cellular therapies and transplantation.

Related Experiment Videos