NCT04983225

The Safety and Tolerability of Initial Periodontal Therapy Combined With Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis

Status unknown Phase 1 Last updated 31 May 2023

What this trial tests

Phase 1 trial testing Human Dental Pulp Stem Cells in Periodontitis in 36 participants. Status unknown.

Timeline

31 July 2021

Primary endpoint
31 July 2024

31 August 2024

Quick facts

Lead sponsor	Peking University Third Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	36
Start date	31 July 2021
Primary completion	31 July 2024
Estimated completion	31 August 2024
Sites	1 location across China

Drugs / interventions tested

• Human Dental Pulp Stem Cells — full drug profile →
• Saline solution

Conditions studied

• Periodontitis — all drugs for Periodontitis →

Sponsor

Peking University Third Hospital

Who can join

Adults 18 to 65, any sex, with Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The principal objective of this trial is to investigate the safety and tolerability of human dental pulp stem cells injection in the treatment of chronic periodontitis. The secondary objective is to provide the basis for dosage regimen for further clinical trials and to evaluate the preliminary efficacy.

Publications & conference data

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

1. Immunomodulatory properties of mesenchymal stem cells/dental stem cells and their therapeutic applications.
   Li P, Ou Q, Shi S, Shao C. · · 2023 · cited 157× · PMID 36973490 · DOI 10.1038/s41423-023-00998-y
2. Clinical trials using dental stem cells: 2022 update.
   Song WP, Jin LY, Zhu MD, Wang H, et al · · 2023 · cited 25× · PMID 37007456 · DOI 10.4252/wjsc.v15.i3.31
3. Immunomodulatory Mechanism and Potential Application of Dental Pulp-Derived Stem Cells in Immune-Mediated Diseases.
   Min Q, Yang L, Tian H, Tang L, et al · · 2023 · cited 23× · PMID 37175774 · DOI 10.3390/ijms24098068
4. Mesenchymal Stromal Cells Derived from Dental Tissues: Immunomodulatory Properties and Clinical Potential.
   Poblano-Pérez LI, Castro-Manrreza ME, González-Alva P, Fajardo-Orduña GR, et al · · 2024 · cited 13× · PMID 38396665 · DOI 10.3390/ijms25041986
5. Research progress on optimization of <i>in vitro</i> isolation, cultivation and preservation methods of dental pulp stem cells for clinical application.
   Wang X, Li F, Wu S, Xing W, et al · · 2024 · cited 6× · PMID 38633667 · DOI 10.3389/fbioe.2024.1305614
6. Characterization of a Stemness-Optimized Purification Method for Human Dental-Pulp Stem Cells: An Approach to Standardization.
   Dieterle MP, Gross T, Steinberg T, Tomakidi P, et al · · 2022 · cited 5× · PMID 36291072 · DOI 10.3390/cells11203204
7. Neural crest-derived mesenchymal stem cells: Fates and perspectives.
   He YL, Chen SJ, Xia DS, Song WP. · · 2025 · PMID 41025106 · DOI 10.4252/wjsc.v17.i9.107689