NCT03874572: MESRIX-SAFETY

Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

Status unknown Phase 1 Last updated 29 January 2021

What this trial tests

Phase 1 trial testing Allogeneic adipose derived stem/stromal cells in Xerostomia Due to Radiotherapy in 10 participants. Status unknown.

Timeline

18 March 2019

Primary endpoint
22 June 2020

1 December 2025

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	18 March 2019
Primary completion	22 June 2020
Estimated completion	1 December 2025
Sites	2 locations across Denmark

Drugs / interventions tested

• Allogeneic adipose derived stem/stromal cells — full drug profile →

Conditions studied

• Xerostomia Due to Radiotherapy — all drugs for Xerostomia Due to Radiotherapy →
• Hyposalivation — all drugs for Hyposalivation →
• Xerostomia — all drugs for Xerostomia →
• Oropharynx Cancer — all drugs for Oropharynx Cancer →

Sponsor

Rigshospitalet, Denmark

Who can join

Adults 18 to 75, any sex, with Xerostomia Due to Radiotherapy or Hyposalivation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stromal cells in the tumor microenvironment: accomplices of tumor progression?
   Zhao Y, Shen M, Wu L, Yang H, et al · · 2023 · cited 271× · PMID 37666813 · DOI 10.1038/s41419-023-06110-6
2. Therapeutic Potential of Mesenchymal Stem Cells for Cancer Therapy.
   Hmadcha A, Martin-Montalvo A, Gauthier BR, Soria B, et al · · 2020 · cited 241× · PMID 32117924 · DOI 10.3389/fbioe.2020.00043
3. Therapeutic Mesenchymal Stem/Stromal Cells: Value, Challenges and Optimization.
   Najar M, Melki R, Khalife F, Lagneaux L, et al · · 2021 · cited 64× · PMID 35096805 · DOI 10.3389/fcell.2021.716853
4. Mesenchymal stem cells and cancer therapy: insights into targeting the tumour vasculature.
   Aravindhan S, Ejam SS, Lafta MH, Markov A, et al · · 2021 · cited 55× · PMID 33685452 · DOI 10.1186/s12935-021-01836-9
5. Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II).
   Lynggaard CD, Grønhøj C, Christensen R, Fischer-Nielsen A, et al · · 2022 · cited 31× · PMID 35435231 · DOI 10.1093/stcltm/szac011
6. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
7. Salivary toxicity from PSMA-targeted radiopharmaceuticals: What we have learned and where we are going.
   Muniz M, Loprinzi CL, Orme JJ, Koch RM, et al · · 2024 · cited 17× · PMID 38703593 · DOI 10.1016/j.ctrv.2024.102748
8. Autologous mesenchymal stem cells offer a new paradigm for salivary gland regeneration.
   Marinkovic M, Tran ON, Wang H, Abdul-Azees P, et al · · 2023 · cited 15× · PMID 37165024 · DOI 10.1038/s41368-023-00224-5