Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients

NCT ID: NCT05924373

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2026-09-30

Brief Summary

The primary objective:To evaluate the efficacy of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients.

The secondary objective:To evaluate the safety of different administration protocols of human dental pulp mesenchymal stem cells for the treatment of chronic periodontitis patients.

The exploratory objective:To investigate the effects of human dental pulp mesenchymal stem cells on biomarkers in gingival crevicular fluid in chronic periodontitis patients.

Detailed Description

This is a multicenter, randomized, double-blind, parallel, placebo-controlled study, including three treatment groups which are single-dose group, two-dose group (low-dose), and two-dose group (high-dose). The patients of single-dose group will receive only one dose on day 1 (D1), and the patients of two-dose groups will receive one dose on D1 and D90 respectively. 68 participants will be enrolled in each group, and be randomized (3:1) to receive human dental pulp mesenchymal stem cells (hDP-MSCs) or placebo (normal saline). Participants in the single-dose group and the two-dose group (high-dose) will receive local injection of 1.0 × 107 hDP-MSCs (0.6mL normal saline suspension) / periodontal defect site or 0.6mL normal saline / periodontal defect site, and participants in the two-dose group (low-dose) will receive local injection of 1.0 × 106 hDP-MSCs (0.6mL normal saline suspension) / periodontal defect site or 0.6mL normal saline / periodontal defect site. All participants will receive basic periodontal treatment simultaneously.

Dosing interval: the dosing interval is set at 89 days, which is based on the results of preclinical trials of hDP-MSCs, the improvement of periodontitis observed on D90 after hDP-MSCs administration, and good safety profile in phase 1 clinical trial.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

two-dose group (low-dose)

Human Dental Pulp Stem Cells Injection: 1X 10\^6 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration.

Group Type: EXPERIMENTAL

Human Dental Fulp Stem Cells

Intervention Type: DRUG

Investigational drugs: Based on the initial periodontal treatment (supragingival cleansing, subgingival scaling and root planning), human pulp stem cell injections will be given for a single or two local injection

two-dose group (high-dose)

Human Dental Pulp Stem Cells Injection: 1X 10\^7 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration.

Group Type: EXPERIMENTAL

Human Dental Fulp Stem Cells

Intervention Type: DRUG

Investigational drugs: Based on the initial periodontal treatment (supragingival cleansing, subgingival scaling and root planning), human pulp stem cell injections will be given for a single or two local injection

single-dose group

Human Dental Fulp Stem Cells Injection: 1X 10\^7 cells/periodontaldefect site.

Group Type: EXPERIMENTAL

Human Dental Fulp Stem Cells

Intervention Type: DRUG

Investigational drugs: Based on the initial periodontal treatment (supragingival cleansing, subgingival scaling and root planning), human pulp stem cell injections will be given for a single or two local injection

Interventions

Human Dental Fulp Stem Cells

Investigational drugs: Based on the initial periodontal treatment (supragingival cleansing, subgingival scaling and root planning), human pulp stem cell injections will be given for a single or two local injection

Intervention Type: DRUG

Other Intervention Names

Initial periodontal therapy

Eligibility Criteria

Inclusion Criteria

• Participants are eligible to be included in the study only if all of the following criteria apply:

1)18 to 65 years old (including threshold), unlimited gender; 2)Radiological examination of the periodontal defect site shows angular bone defect; 3)The probing depth (PD) at the periodontal defect site is 4 to 8 mm at baseline; 4)Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures; 5)Voluntarily participate in the clinical study, understand and sign the informed consent;

Exclusion Criteria

• Participants are excluded from the study if any of the following criteria apply:

1. Participants with severe periodontal diseases (alveolar bone resorption exceeds two-thirds of the tooth root length) which affect the investigator's judgment;

2. The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement is grade 2; vertical loosening is grade 3);

3. The studied tooth with occlusal trauma which affect the investigator's judgment;

4. Participants with surgical treatment of previous periodontal defect sites and adjacent periodontal tissues;

5. Participants with non-steroid anti-inflammatory drug, steroid hormone therapy, and/or other hormone (except topical hormones) treatment within past 3 months of the screening visit, and/or previous use of bisphosphonates;

6. Participants with severe systemic infection within past 3 months of the screening visit, or antibiotics treatment within past 72h of the screening visit;

7. Participants with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after receiving the optimal antihypertensive therapy);

8. Participants with severe or uncontrolled diseases in any system (cardiac, hepatic, renal, respiratory, hematologic, endocrine, nervous, or psychiatric);

9. Participants are known to be allergic to any materials that may be used during surgery (allergy-prone constitution or history of allergy to blood products);

10. Any of the following abnormalities in clinical laboratory tests at screening: ALT > 3 ULN, total bilirubin > 1.5 ULN, serum creatinine > 1.5 ULN, international normalized ratio (INR) ≥ 1.5 ULN or activated partial thromboplastin time (APTT) ≥ 1.5 ULN (except for patients receiving anticoagulation therapy), Hb < 80 g/L, or PLT < 75.0×109/L;

11. Positive result for any of the following tests at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab);

12. Females who are pregnant or breastfeeding;

13. Participants and their partners who plan to conceive or do not agree to use the effective non-pharmacological method of contraceptive during the trial from screening visit to 6 months after the end of the trial;

14. Participants participated in other clinical studies within past 3 months of the screening visit;

15. Participants with a history of smoking addiction within past 12 months of the screening visit (the number of cigarettes smoked per day ≥ 10); Other circumstances deemed inappropriate by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao Wang, Master

Role: PRINCIPAL_INVESTIGATOR

Department of Stomatology, Peking University Third Hospital, Beijing, China

Locations

Peking University Third Hospital

Beijing, Beijng, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Wang, Master

Role: CONTACT

bysykqpeking@126.com

+86 010-82266334

Facility Contacts

Meng Wan, doctor

Role: primary

wanmengpeking@126.com

+86 010-82266263

References

Liu Y, Liu Y, Hu J, Han J, Song L, Liu X, Han N, Xia X, He J, Meng H, Wan M, Wang H, Liu X, Gao Z, Wang X, Wu C, Wang S. Impact of allogeneic dental pulp stem cell injection on tissue regeneration in periodontitis: a multicenter randomized clinical trial. Signal Transduct Target Ther. 2025 Jul 31;10(1):239. doi: 10.1038/s41392-025-02320-w.

Reference Type: DERIVED

PMID: 40739139 (View on PubMed)

Other Identifiers

SH-hDP-MSC-102

Identifier Type: -

Identifier Source: org_study_id