Evidence map›Paper›PMID 38543329›Full record

ArticlePharmaceutics2024

Optimization of the Production Process of Clinical-Grade Human Salivary Gland Organoid-Derived Cell Therapy for the Treatment of Radiation-Induced Xerostomia in Head and Neck Cancer.

Jacoba van Zanten, Annelies Jorritsma-Smit, Hans Westra, Mirjam Baanstra, Anne de Bruin-Jellema, Derk Allersma, Bahez Gareb, Rob P Coppes

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% of its field
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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. New developments and applications of human organoids.Nature reviews. Molecular cell biology · 2026
    Review
  4. Article
  5. Article
  6. Review
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  8. Article
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  10. Article
  11. Review
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  13. Article
  14. Cancer therapy-related salivary dysfunction.The Journal of clinical investigation · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Jacoba van ZantenDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.
Annelies Jorritsma-SmitDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.
Hans WestraDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.
Mirjam BaanstraDepartment of BioMedical Sciences, University of Groningen (RUG) and University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.
Anne de Bruin-JellemaDepartment of BioMedical Sciences, University of Groningen (RUG) and University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.
Derk AllersmaDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.
Bahez GarebDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.ORCID 0000-0001-8672-391X
Rob P CoppesDepartment of BioMedical Sciences, University of Groningen (RUG) and University Medical Center Groningen (UMCG), 9713 GZ Groningen, The Netherlands.ORCID 0000-0001-5503-1064
University Medical Center Groningen · NL

Funding

Netherlands Organisation for Health Research and Development 116001023
6 · The paper itself

Abstract

Head and neck cancer is a common cancer worldwide. Radiotherapy has an essential role in the treatment of head and neck cancers. After irradiation, early effects of reduced saliva flow and hampered water secretion are seen, along with cell loss and a decline in amylase production. Currently, there is no curative treatment for radiation-induced hyposalivation/xerostomia. This study aimed to develop and optimize a validated manufacturing process for salivary gland organoid cells containing stem/progenitor cells using salivary gland patient biopsies as a starting material. The manufacturing process should comply with GMP requirements to ensure clinical applicability. A laboratory-scale process was further developed into a good manufacturing practice (GMP) process. Clinical-grade batches complying with set acceptance and stability criteria were manufactured. The results showed that the manufactured salivary gland-derived cells were able to self-renew, differentiate, and show functionality. This study describes the optimization of an innovative and promising novel cell-based therapy.

Indexed as

ATMPcell therapyGMPhuman salivary gland stem cellshyposalivationorganoids

Identifiers

PMID38543329
PMCPMC10976128
OpenAlexW4393036831

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.