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

Current regulatory issues in cell and tissue therapy.

S R Burger1

  • 1Advanced Cell and Gene Therapy, LLC, Chapel Hill, NC 27516, USA. celltherapy@ac-gt.com

Cytotherapy
|August 29, 2003
PubMed
Summary
This summary is machine-generated.

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

Development of an infusible-grade solution for non-cryopreserved hematopoietic cell storage.

Cytotherapy·2009
Same author

High peripheral blood progenitor cell counts enable autologous backup before stem cell transplantation for malignant infantile osteopetrosis.

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation·2005
Same author

IL-2-based immunotherapy after autologous transplantation for lymphoma and breast cancer induces immune activation and cytokine release: a phase I/II trial.

Bone marrow transplantation·2003
Same author

Design and operation of a current good manufacturing practices cell-engineering laboratory.

Cytotherapy·2002
Same author

Hyaluronan synthase elevation in metastatic prostate carcinoma cells correlates with hyaluronan surface retention, a prerequisite for rapid adhesion to bone marrow endothelial cells.

The Journal of biological chemistry·2001
Same author

HPC viability measurement: trypan blue versus acridine orange and propidium iodide.

Transfusion·2000
Same journal

Dialysis bioreactor enables high-density, serum-free expansion of dental pulp-derived mesenchymal stromal cells with enhanced secretome.

Cytotherapy·2026
Same journal

Beyond the synapses: should we anticipate neurotransmitter signaling when manufacturing CAR-T cells for brain tumors?

Cytotherapy·2026
Same journal

Curative treatment for severe sickle cell disease: allogeneic hematopoietic cell transplant or gene therapy.

Cytotherapy·2026
Same journal

Manufacturing strategies for prolonged CAR-T cell persistence.

Cytotherapy·2026
Same journal

Overcoming five main challenges to targeting hematologic malignancies.

Cytotherapy·2026
Same journal

Mesenchymal stromal cell-based therapy in the COVID-19 pandemic: results from an academic phase I/II double-blind, randomized, placebo-controlled clinical trial and reflections for the field.

Cytotherapy·2026
See all related articles

Cell-based therapies are expanding, but risks necessitate regulation. New rules like Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) ensure safety and efficacy for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Area of Science:

  • Regenerative Medicine
  • Biotechnology
  • Regulatory Science

Background:

  • Cell-based therapies have advanced significantly, moving beyond transplantation to tissue repair, regeneration, and immune functions.
  • The increasing complexity of human cells, tissues, and cellular and tissue-based products (HCT/Ps) introduces potential risks of adverse events.
  • Regulatory bodies are implementing frameworks to manage these risks and ensure product safety.

Purpose of the Study:

  • To outline the regulatory framework for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
  • To explain the roles of proposed Good Tissue Practices (GTP) and existing Good Manufacturing Practices (GMP) in ensuring product safety and efficacy.
  • To highlight the tiered, risk-based approach to regulating HCT/Ps.

Main Methods:

Related Experiment Videos

  • Implementation of a tiered, risk-based regulatory structure by the US Food and Drug Administration.
  • Establishment of Good Tissue Practices (GTP) to prevent contamination and ensure product integrity.
  • Application of Good Manufacturing Practices (GMP) for enhanced process control and product characterization for higher-risk products.

Main Results:

  • All HCT/Ps must comply with GTPs.
  • Higher-risk HCT/Ps require adherence to both GTPs and GMPs, including premarket approval via the Investigational New Drug (IND) mechanism.
  • These regulations aim to increase safety, control, and data reliability in cell-based therapies.

Conclusions:

  • The regulatory framework, including GTP and GMP, is essential for managing the risks associated with advanced cell-based therapies.
  • Compliance with these regulations supports good clinical care and enables robust scientific advancement.
  • The tiered approach ensures appropriate oversight based on the potential risk posed by different HCT/Ps.