ReviewJournal of clinical microbiology2023
Sterility Testing for Hematopoietic Stem Cells.
Review in Journal of clinical microbiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 20 citations in OpenAlex.
- Direct microbiota profiling of apheresis-associated products for microbiological insights in cell therapy.Scientific reports · 2026Article
- Accelerated sterility testing unlocks safe delivery of life-saving therapies.Nature biomedical engineering · 2026Article
- One-day rapid sterility test for human-derived biopharmaceuticals.Nature biomedical engineering · 2026Article
- Evaluation of an automated blood culture detection system for sterility testing of cellular and gene therapy products.Microbiology spectrum · 2026Article
- Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings.Journal of clinical microbiology · 2025Article
- Reply to "Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings".Journal of clinical microbiology · 2025Article
- Comprehensive evaluation of the clinical feasibility of using perinatal medical waste as a source for fetal mesenchymal stem cell banking under good manufacturing practice conditions.Cell and tissue banking · 2025Observational
- All you need to know about equipment validation for sterility testing.Journal of clinical microbiology · 2025Review
- Body Fluid-Derived Stem Cells: Powering Innovative, Less-Invasive Cell Therapies.International journal of molecular sciences · 2025Review
- Machine learning aided UV absorbance spectroscopy for microbial contamination in cell therapy products.Scientific reports · 2025Article
- Synergistic potential of stem cells and microfluidics in regenerative medicine.Molecular and cellular biochemistry · 2025Review
- Moving Toward Collecting High-Quality Umbilical Cord Blood: Application of Quality Control Circle.Journal of blood medicine · 2025Article
- Challenges and mitigation strategies associated with Burkholderia cepacia complex contamination in pharmaceutical manufacturing.Archives of microbiology · 2024Review
- Advances in ex vivo expansion of hematopoietic stem and progenitor cells for clinical applications.Frontiers in bioengineering and biotechnology · 2024Review
- Performance of the MSI-2 Database for Fungal Identification by Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry from Cleanroom Environments.Journal of clinical microbiology · 2023Article
- Advancing herbal medicine: enhancing product quality and safety through robust quality control practices.Frontiers in pharmacology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
Over the last two decades, rapid technological advances have led to the wide adoption of cell and gene therapy products for the treatment of a variety of disease states. In this study, we reviewed the literature between 2003 and 2021 to provide a summary of overarching trends associated with microbial contamination in hematopoietic stem cells (HSCs) derived from peripheral blood, bone marrow, and cord blood. We provide a brief background on the regulatory context for human cells, tissues, and cellular and tissue-based products (HCT/Ps) as regulated by the US Food and Drug Administration (FDA), sterility testing expectations for autologous (Section 361) and allogeneic (Section 351) HSC products, and discuss clinical risks associated with the infusion of a contaminated HSC product. Finally, we discuss the expectations for current good tissue practices (cGTP) and current good manufacturing practices (cGMP) for the manufacturing and testing of HSC based on Section 361 and Section 351 categorization, respectively. We provide commentary on what is practiced in the field and discuss the critical need for updates to professional standards that keep pace with advancing technologies with an aim to clarify expectations for manufacturing and testing facilities to improve standardization across institutions.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.