NCT06764004

The Effect of Human Umbilical Cord Mesenchymal Stem Cells and Exosomes on the Healing of Postoperative Pain and Periapical Lesions in the Treatment of Apical Periodontitis: Randomized Controlled Clinical Study

Not yet recruiting Phase 1, PHASE2 Last updated 8 January 2025

What this trial tests

Phase 1, PHASE2 trial testing Stem Cell Product in Apical Periodontitis in 45 participants. Not yet recruiting.

Timeline

1 January 2025

Primary endpoint
1 February 2025

1 May 2025

Quick facts

Lead sponsor	TC Erciyes University
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	45
Start date	1 January 2025
Primary completion	1 February 2025
Estimated completion	1 May 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Stem Cell Product — full drug profile →
• Bleeding and clots — full drug profile →

Conditions studied

• Apical Periodontitis — all drugs for Apical Periodontitis →

Sponsor

TC Erciyes University

Who can join

Adults 9 to 15, any sex, with Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this study is to evaluate the effect of Mesenchymal Stem Cells (MSCs) isolated from the umbilical cord and exosomes derived from these cells on the success of the treatment in the regenerative endodontic treatment of necrotic open apex molar teeth.

Regenerative endodontic treatment aims to disinfect root canals and revascularize pulp tissue. Our goals in this study are; obtaining umbilical cord-derived MSCs, obtaining exosomes derived from umbilical cord MSCs, selecting patients with molar teeth with necrotic open apex and periapical lesion, initiation of regenerative endodontic treatment and disinfection of root canals, induction of bleeding in the periapical region and formation of a blood clot in the root canal in the 1st patient group, in the 2nd patient group, umbilical cord-derived MSCs were placed in the root canals without bleeding in the periapical region, in the 3rd patient group, placement of exosomes from umbilical cord-derived MSCs into the root canals without causing bleeding in the periapical region, it is the follow-up of patients at regular intervals for up to 1 year after treatment is completed.

Publications & conference data

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

1. Exosomes in inflammation and cancer: from bench to bedside applications.
   Huang S, Yan F, Qiu Y, Liu T, et al · · 2025 · cited 20× · PMID 40490663 · DOI 10.1186/s43556-025-00280-9
2. The tiny giants of regeneration: MSC-derived extracellular vesicles as next-generation therapeutics.
   Zhang T, Zhang L, Ma X, Song W. · · 2025 · cited 6× · PMID 40746857 · DOI 10.3389/fcell.2025.1612589
3. Biological Nanotherapeutics Derived From Human Umbilical Cord Mesenchymal Stem Cells: Mechanisms and Translational Potential in Multisystem Therapies for Regeneration and Oncology.
   Zhang R, Xu Z, Xu S, Li R, et al · · 2025 · cited 3× · PMID 41078403 · DOI 10.2147/ijn.s550390
4. Current Perspectives on Mesenchymal Stem Cells as a Potential Treatment for Periodontal Diseases and Conditions.
   Cai S, Li C, Wei B, Ye Z, et al · · 2025 · cited 2× · PMID 40838652 · DOI 10.1002/dvg.70024
5. Cell derived nanovesicles for oral and craniofacial tissue regeneration.
   Zhong L, Marschall JS, Shin K, Sun H. · · 2026 · PMID 42065569 · DOI 10.1039/d6nr00456c
6. The roles and clinical applications of mesenchymal stem cells and their exosomes in hematologic diseases.
   Deng M, Zhang X, Zhang Y. · · 2025 · PMID 41444972 · DOI 10.1186/s13287-025-04880-8