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

Last updated: May 26, 2024
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Periodontitis

Treatment

Human Dental Fulp Stem Cells

Clinical Study ID

NCT05924373
SH-hDP-MSC-102
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants are eligible to be included in the study only if all of the followingcriteria 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

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:
  1. Participants with severe periodontal diseases (alveolar bone resorption exceedstwo-thirds of the tooth root length) which affect the investigator's judgment;

  2. The grade of studied tooth looseness ≥ grade 3 at baseline (only buccolingualmovement 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'sjudgment;

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

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

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

  7. Participants with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic bloodpressure ≥ 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 duringsurgery (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 partialthromboplastin time (APTT) ≥ 1.5 ULN (except for patients receivinganticoagulation therapy), Hb < 80 g/L, or PLT < 75.0×109/L;

  11. Positive result for any of the following tests at screening: hepatitis Bsurface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), humanimmunodeficiency 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 theeffective non-pharmacological method of contraceptive during the trial fromscreening visit to 6 months after the end of the trial;

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

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

Study Design

Total Participants: 204
Treatment Group(s): 1
Primary Treatment: Human Dental Fulp Stem Cells
Phase: 2
Study Start date:
November 27, 2023
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijng 100191
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.