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 Concept Videos

Multipotency of Hematopoietic Stem Cells01:19

Multipotency of Hematopoietic Stem Cells

3.2K
The hematopoietic stem cells or HSCs are multipotent, meaning they can differentiate and give rise to all blood and immune cells. HSCs are maintained in the quiescent stage until an external stimulus initiates their differentiation. The multipotent HSCs exist as two heterogeneous populations, long-term repopulating cells (LTRC) and short-term repopulating cells (STRC). The two HSC populations have different surface markers or receptors and are classified based on quiescence and long-term...
3.2K

You might also read

Related Articles

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

Sort by
Same author

Development, Validation, and Implementation of a Pharmaceutical Facility Disinfection Program.

PDA journal of pharmaceutical science and technology·2026
Same author

PAT Implementation - Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products.

PDA journal of pharmaceutical science and technology·2025
Same author

Reply to "Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings".

Journal of clinical microbiology·2025
Same author

Considerations for the Validation of Non-CFU Based Bio-Fluorescent Particle Counting Technologies.

PDA journal of pharmaceutical science and technology·2025
Same author

All you need to know about equipment validation for sterility testing.

Journal of clinical microbiology·2025
Same author

Comparison of BIOBALL and EZ-Accu Shot for accurate quantification as certified quality control reference material.

Journal of clinical microbiology·2025
Same journal

Ebola laboratory preparedness at frontline hospitals: can we or can't we?

Journal of clinical microbiology·2026
Same journal

Reporting macrolide-resistant <i>Mycoplasma pneumoniae</i>: a diagnostic obligation?

Journal of clinical microbiology·2026
Same journal

Diagnostic value of HHV-6A/B genotyping in immunocompromised adults.

Journal of clinical microbiology·2026
Same journal

Multicenter performance evaluation of the Simplexa <i>C. auris</i> Direct assay for the detection of <i>Candida auris</i> colonization in bilateral axilla/groin swabs.

Journal of clinical microbiology·2026
Same journal

Comparison of blood culture contamination rates with standard practice versus two blood diversion devices at a single institution.

Journal of clinical microbiology·2026
Same journal

Risk assessment and mitigation of hepatitis C virus RNA carryover contamination in a reflex testing algorithm.

Journal of clinical microbiology·2026
See all related articles

Related Experiment Video

Updated: Aug 8, 2025

Isolation Method for Long-Term and Short-Term Hematopoietic Stem Cells
06:41

Isolation Method for Long-Term and Short-Term Hematopoietic Stem Cells

Published on: May 19, 2023

1.9K

Sterility Testing for Hematopoietic Stem Cells.

Tony Cundell1, J Wade Atkins2, Anna F Lau3

  • 1Microbiological Consulting, LLC, Rye, New York, USA.

Journal of Clinical Microbiology
|February 27, 2023
PubMed
Summary
This summary is machine-generated.

Microbial contamination in hematopoietic stem cells (HSCs) poses risks in cell and gene therapies. This review highlights trends, regulatory expectations, and the need for updated standards to ensure product safety and efficacy.

Keywords:
bone marrowclinical riskcontaminationcord bloodhematopoietic stem cellsperipheral bloodsterility testing

More Related Videos

Competitive Transplants to Evaluate Hematopoietic Stem Cell Fitness
08:53

Competitive Transplants to Evaluate Hematopoietic Stem Cell Fitness

Published on: August 31, 2016

15.3K
Detection of Residual Donor Erythroid Progenitor Cells after Hematopoietic Stem Cell Transplantation for Patients with Hemoglobinopathies
11:59

Detection of Residual Donor Erythroid Progenitor Cells after Hematopoietic Stem Cell Transplantation for Patients with Hemoglobinopathies

Published on: September 6, 2017

7.4K

Related Experiment Videos

Last Updated: Aug 8, 2025

Isolation Method for Long-Term and Short-Term Hematopoietic Stem Cells
06:41

Isolation Method for Long-Term and Short-Term Hematopoietic Stem Cells

Published on: May 19, 2023

1.9K
Competitive Transplants to Evaluate Hematopoietic Stem Cell Fitness
08:53

Competitive Transplants to Evaluate Hematopoietic Stem Cell Fitness

Published on: August 31, 2016

15.3K
Detection of Residual Donor Erythroid Progenitor Cells after Hematopoietic Stem Cell Transplantation for Patients with Hemoglobinopathies
11:59

Detection of Residual Donor Erythroid Progenitor Cells after Hematopoietic Stem Cell Transplantation for Patients with Hemoglobinopathies

Published on: September 6, 2017

7.4K

Area of Science:

  • Cell and Gene Therapy
  • Hematopoietic Stem Cell Transplantation
  • Microbial Contamination

Background:

  • Cell and gene therapies have advanced significantly, increasing the adoption of hematopoietic stem cells (HSCs).
  • Microbial contamination in HSC products presents a serious clinical risk.
  • Regulatory frameworks like the US FDA's oversight of human cells, tissues, and cellular and tissue-based products (HCT/Ps) are crucial.

Purpose of the Study:

  • To review literature from 2003-2021 on microbial contamination trends in HSCs.
  • To summarize regulatory expectations for sterility testing of autologous (Section 361) and allogeneic (Section 351) HSC products.
  • To discuss clinical risks and current practices in HSC manufacturing and testing.

Main Methods:

  • Literature review of scientific publications and regulatory guidance.
  • Analysis of trends in microbial contamination associated with HSCs from various sources (peripheral blood, bone marrow, cord blood).
  • Examination of regulatory requirements under current good tissue practices (cGTP) and current good manufacturing practices (cGMP).

Main Results:

  • Identified overarching trends in microbial contamination within HSC products over two decades.
  • Outlined sterility testing expectations for different categories of HSC products (Section 361 vs. Section 351).
  • Discussed clinical risks associated with infusing contaminated HSC products.

Conclusions:

  • There is a critical need to update professional standards for manufacturing and testing HSCs to align with technological advancements.
  • Clarifying expectations for facilities is essential for improving standardization across institutions.
  • Enhanced standardization and updated practices are vital for ensuring the safety and efficacy of cell and gene therapies using HSCs.