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

NCT05924373 | Recruiting Phase 2

• 1 other identifier: SH-hDP-MSC-102
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Human Dental Pulp Stem Cell

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in height of the periodontal bone defect

  Changes from baseline in height of the periodontal bone defect which will be examined by CBCT at D90±7 and D180±14 (primary efficacy endpoint)

  at baseline, 90 days, 180 days

Secondary Outcomes (51)

• Changes from baseline in respiration rate of Vital Signs

  within 180 days after administration

• Changes from baseline in heart rate of Vital Signs

  within 180 days after administration

• Changes from baseline in blood pressure of Vital Signs

  within 180 days after administration

• Changes from baseline in body temperature of Vital Signs

  within 180 days after administration

• Changes from baseline in red blood cell count of Laboratory Examination

  within 180 days after administration

Other Outcomes (11)

• Change from baseline in interleukin-6 (IL-6)

  at baseline, 90 days, 180 days，360 days，720 days

• Change from baseline in tumor necrosis factor-alpha (TNF-α)

  at baseline, 90 days, 180 days，360 days，720 days

• Change from baseline in matrix metalloproteinase-8 (MMP-8)

  at baseline, 90 days, 180 days，360 days，720 days

Study Arms (3)

single-dose group

EXPERIMENTAL

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

Drug: Human Dental Fulp Stem Cells

two-dose group (low-dose)

EXPERIMENTAL

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

Drug: Human Dental Fulp Stem Cells

two-dose group (high-dose)

EXPERIMENTAL

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

Drug: Human Dental Fulp Stem Cells

Interventions

Human Dental Fulp Stem Cells 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

Also known as: Initial periodontal therapy

single-dose group; two-dose group (high-dose); two-dose group (low-dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Participants with severe periodontal diseases (alveolar bone resorption exceeds two-thirds of the tooth root length) which affect the investigator's judgment;
• 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);
• The studied tooth with occlusal trauma which affect the investigator's judgment;
• Participants with surgical treatment of previous periodontal defect sites and adjacent periodontal tissues;
• 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;
• Participants with severe systemic infection within past 3 months of the screening visit, or antibiotics treatment within past 72h of the screening visit;
• 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);
• Participants with severe or uncontrolled diseases in any system (cardiac, hepatic, renal, respiratory, hematologic, endocrine, nervous, or psychiatric);
• 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);
• 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;
• 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);
• Females who are pregnant or breastfeeding;
• 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;
• Participants participated in other clinical studies within past 3 months of the screening visit;

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Capital Medical University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijng, 100191, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40739139 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Xiao Wang, Master

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Wang, Master

CONTACT

+86 010-82266334; bysykqpeking@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, double-blind, parallel, placebo-controlled study

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 29, 2023
• Study Start: November 27, 2023
• Primary Completion: March 7, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 29, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)