Evidence map›Paper›PMID 35435231›Full record

ArticleStem cells translational medicine2022

Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II).

Charlotte Duch Lynggaard, Christian Grønhøj, Robin Christensen, Anne Fischer-Nielsen, Jacob Melchiors, Lena Specht, Elo Andersen, Jann Mortensen, Peter Oturai, Gry Hoffmann Barfod and 7 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Stem cells translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
5.9field-weighted citation impact, top 3% 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

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Still thirsting for a fix.Translational cancer research · 2025
    Article
  12. Radiation-Therapy Related Salivary Dysfunction.Seminars in radiation oncology · 2025
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Cancer therapy-related salivary dysfunction.The Journal of clinical investigation · 2024
    Review
  18. Review
  19. Review
  20. Article
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

17 authors at 5 institutions in 1 country.

Charlotte Duch LynggaardDepartment of Otolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-1637-2146
Christian GrønhøjDepartment of Otolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Robin ChristensenSection for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Anne Fischer-NielsenDepartment of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Jacob MelchiorsDepartment of Otolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Lena SpechtDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6902-2190
Elo AndersenDepartment of Oncology, Herlev Hospital, Copenhagen University Hospital, Copenhagen, Denmark.
Jann MortensenDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1399-8995
Peter OturaiDepartment of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Gry Hoffmann BarfodAGiR, Department of Geoscience, Aarhus University, Aarhus C, Denmark.
Eva Kannik HaastrupDepartment of Clinical Immunology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Michael Møller-HansenDepartment of Ophthalmology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Mandana Haack-SørensenCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Annette EkblondCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Jens KastrupCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-3668-5393
Siri Beier JensenDepartment of Dentistry and Oral Health, Aarhus University, Copenhagen, Denmark.
Christian von BuchwaldDepartment of Otolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Copenhagen University Hospital · DKUniversity of Copenhagen · DKAarhus University · DKHerlev Hospital · DKUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)-xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P = .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P = .017) mL/minute. XQ summary score decreased by 22.6 units (P = .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P = .0013), sticky saliva 23.3 (P = .0015), and swallowing 10.0 (P = .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.

Indexed as

Head and Neck NeoplasmsHematopoietic Stem Cell TransplantationMesenchymal Stem CellsRadiation InjuriesXerostomiaFemaleHumansMalecancerclinical trialsmesenchymal stem cellsstem cellsxerostomia

Identifiers

PMID35435231
PMCPMC9154319
OpenAlexW4214837548

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.