Evidence map›Paper›PMID 38938599›Full record

ArticleJournal of extracellular biology2022

GMP-compliant manufacturing of biologically active cell-derived vesicles produced by extrusion technology.

Hui-Chong Lau, Dong Woo Han, Jinhee Park, Edwine Lehner, Carina Kals, Claudia Arzt, Elisabeth Bayer, Daniela Auer, Tanja Schally, Eva Grasmann and 8 more

Erratum issuedAbstract read
In one paragraph

Article in Journal of extracellular biology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. Review
  2. Review
  3. Pathogens (Basel, Switzerland) · 2026
    Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Extracellular Vesicle-Based Drug Delivery Systems in Cancer Therapy.International journal of molecular sciences · 2025
    Review
  14. New therapeutic strategies for malaria.Biophysical reviews · 2025
    Review
  15. Article
  16. Review
  17. Article
  18. Trends in Developing Extracellular Vesicle-Based Therapeutics.Brain tumor research and treatment · 2024
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Hui-Chong LauBioDrone Research Institute MDimune Inc. Seoul Korea.
Dong Woo HanBioDrone Research Institute MDimune Inc. Seoul Korea.
Jinhee ParkBioDrone Research Institute MDimune Inc. Seoul Korea.
Edwine LehnerGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Carina KalsGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Claudia ArztTransfer Centre for Extracellular Vesicle Theralytic Technologies (EV-TT) Salzburg Austria.
Elisabeth BayerGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Daniela AuerGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Tanja SchallyGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Eva GrasmannTransfer Centre for Extracellular Vesicle Theralytic Technologies (EV-TT) Salzburg Austria.
Han FangTransfer Centre for Extracellular Vesicle Theralytic Technologies (EV-TT) Salzburg Austria.
Jae-Young LeeDepartment of Ophthalmology, Eunpyeong St. Mary's Hospital, College of Medicine The Catholic University of Korea Seoul Korea.
Hyun Soo LeeDepartment of Ophthalmology, Eunpyeong St. Mary's Hospital, College of Medicine The Catholic University of Korea Seoul Korea.
Jinah HanBioDrone Therapeutics Inc. Seattle USA.
Mario GimonaGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Eva RohdeGMP Unit, Spinal Cord Injury & Tissue Regeneration Centre Salzburg (SCI-TReCS) Paracelsus Medical University Salzburg Austria.
Shingyu BaeBioDrone Research Institute MDimune Inc. Seoul Korea.
Seung Wook OhBioDrone Research Institute MDimune Inc. Seoul Korea.ORCID https://orcid.org/0000-0001-7632-6822

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Extracellular vesicles (EVs) released by a variety of cell types have been shown to act as a natural delivery system for bioactive molecules such as RNAs and proteins. EV therapy holds great promise as a safe and cell-free therapy for many immunological and degenerative diseases. However, translation to clinical application is limited by several factors, including insufficient large-scale manufacturing technologies and low yield. We have developed a novel drug delivery platform technology, BioDrone™, based on cell-derived vesicles (CDVs) produced from diverse cell sources by using a proprietary extrusion process. This extrusion technology generates nanosized vesicles in far greater numbers than naturally obtained EVs. We demonstrate that the CDVs are surrounded by a lipid bilayer membrane with a correct membrane topology. Physical, biochemical and functional characterisation results demonstrate the potential of CDVs to act as effective therapeutics. Umbilical cord mesenchymal stem cell (UCMSC)-derived CDVs exhibit a biological activity that is similar to UCMSCs or UCMSC-derived EVs. Lastly, we present the establishment of a GMP-compliant process to allow the production of a large number of UCMSC-CDVs in a reproducible manner. GMP-compliant manufacturing of CDVs will facilitate the preclinical and clinical evaluation of these emerging therapeutics in anti-inflammatory or regenerative medicine. This study also represents a crucial step in the development of this novel drug delivery platform based on CDVs.

Indexed as

cell‐derived vesiclesdrug delivery platformextrusionGMP‐compliant manufacturingumbilical cord mesenchymal stem cell

Identifiers

PMID38938599
PMCPMC11080851

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.