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Related Concept Videos

Stem Cell Culture01:17

Stem Cell Culture

Stem cell research aims to find ways to use stem cells to regenerate and repair cellular damage. Over time, most adult cells undergo the wear and tear of aging and lose their ability to divide and repair themselves. Stem cells do not display a particular morphology or function. Adult stem cells, which exist as a small subset of cells in most tissues, keep dividing and can differentiate into a number of specialized cells generally formed by that tissue. These cells enable the body to renew and...
Embryonic Stem Cells00:57

Embryonic Stem Cells

Embryonic stem (ES) cells were first discovered in mice in 1981 by Martin Evans. In 1998, James Thomson identified a method to isolate embryonic stem cells from humans. Human embryonic stem cells (hESCs) are obtained from 3-5 day old embryos that remain unused after an in vitro fertilization procedure.
ES cells are grown in a culture medium where they can divide indefinitely, creating ES cell lines. Under certain conditions, ES cells can differentiate, either spontaneously into a variety of...
Embryonic Stem Cells00:58

Embryonic Stem Cells

Embryonic stem (ES) cells are undifferentiated pluripotent cells, meaning they can produce any cell type in the body. This gives them tremendous potential in science and medicine since they can generate specific cell types for use in research or to replace body cells lost due to damage or disease.
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Induced Pluripotent Stem Cells01:13

Induced Pluripotent Stem Cells

Stem cells are undifferentiated cells that divide and produce different types of cells. Ordinarily, cells that have differentiated into a specific cell type are post-mitotic—that is, they no longer divide. However, scientists have found a way to reprogram these mature cells so that they “de-differentiate” and return to an unspecialized, proliferative state. These cells are also pluripotent like embryonic stem cells—able to produce all cell types—and are therefore called induced pluripotent stem...
Induced Pluripotent Stem Cells01:06

Induced Pluripotent Stem Cells

Stem cells are undifferentiated cells that divide and produce different cell types. Ordinarily, cells that have differentiated into a specific cell type are terminally differentiated; however, scientists have found a way to reprogram these mature cells so that they dedifferentiate and return to an unspecialized, proliferative state. These cells are pluripotent like embryonic stem cells—able to produce all cell types—and are called induced pluripotent stem cells (iPSCs).
Somatic cells are...

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Related Experiment Video

Updated: Jun 28, 2026

Derivation and Characterization of a Transgene-free Human Induced Pluripotent Stem Cell Line and Conversion into Defined Clinical-grade Conditions
10:48

Derivation and Characterization of a Transgene-free Human Induced Pluripotent Stem Cell Line and Conversion into Defined Clinical-grade Conditions

Published on: November 26, 2014

Stem-cell-derived products: an FDA update.

Malcolm Moos1

  • 1Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.

Trends in Pharmacological Sciences
|October 22, 2008
PubMed
Summary

Stem cell therapies show therapeutic promise, with human clinical trials nearing. Careful risk-benefit evaluation is crucial for patient safety in these novel regenerative medicine trials.

Area of Science:

  • Regenerative Medicine
  • Cellular Therapy
  • Biotechnology

Background:

  • Stem cell-derived products are gaining significant research and public interest due to their therapeutic potential.
  • Human clinical trials for stem cell therapies are anticipated in the near future, marking a significant advancement in regenerative medicine.

Purpose of the Study:

  • To evaluate the potential benefits and risks associated with stem cell-derived products in clinical trials.
  • To ensure a favorable risk-benefit balance for participants in upcoming stem cell therapy trials.
  • To assess the regulatory landscape for stem cell therapies, considering existing frameworks for cellular therapies.

Main Methods:

  • Review of current knowledge on stem cell product characteristics.
  • Comparative analysis of stem cell-derived products with existing FDA-regulated cellular therapies.

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Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow
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Last Updated: Jun 28, 2026

Derivation and Characterization of a Transgene-free Human Induced Pluripotent Stem Cell Line and Conversion into Defined Clinical-grade Conditions
10:48

Derivation and Characterization of a Transgene-free Human Induced Pluripotent Stem Cell Line and Conversion into Defined Clinical-grade Conditions

Published on: November 26, 2014

Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids
11:01

Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids

Published on: September 25, 2016

Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow
09:03

Human Mesenchymal Stem Cell Processing for Clinical Applications Using a Closed Semi-Automated Workflow

Published on: March 17, 2023

  • Evaluation of potential, theoretical, and unsuspected risks versus benefits.
  • Main Results:

    • Stem cell-derived products share fundamental biological characteristics with other regulated cellular therapies.
    • Existing regulatory authorities can be applied to stem cell-derived products.
    • Specific properties of stem cell products necessitate careful and thorough evaluation.

    Conclusions:

    • Stem cell therapies hold significant therapeutic promise, warranting careful consideration of risks and benefits.
    • Current regulatory frameworks are adaptable for stem cell-derived products.
    • Ongoing vigilance and evaluation are essential as stem cell therapies advance towards clinical application.