Using dental stem cells to treat chronic gum disease

A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate Efficacy and Safety of Local Injection of Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients.

This study is testing whether dental stem cells can help people with chronic gum disease feel better and improve their oral health.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Locations: 1 site (Beijing, Beijng)
• Trial ID: NCT05924373 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of human dental pulp mesenchymal stem cells (hDP-MSCs) in treating patients with chronic periodontitis. It is a multicenter, randomized, double-blind, parallel, placebo-controlled study involving three treatment groups: a single-dose group, a low-dose two-dose group, and a high-dose two-dose group. Participants will receive either hDP-MSCs or a placebo, with the primary focus on assessing the efficacy of different administration protocols and the secondary focus on safety. Additionally, the study will explore the effects of hDP-MSCs on biomarkers in the gingival crevicular fluid of participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with specific periodontal defects and probing depths between 4 to 8 mm.

Not a fit: Patients with severe periodontal diseases or significant tooth looseness may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from chronic periodontitis.

How similar studies have performed: While the use of stem cells in periodontal treatment is an emerging field, this specific approach has not been widely tested in prior studies.

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.

Where this trial is running

Beijing, Beijng

• Peking University Third Hospital — Beijing, Beijng, China (RECRUITING)

Study contacts

• Principal investigator: Xiao Wang, Master — Department of Stomatology, Peking University Third Hospital, Beijing, China
• Study coordinator: Xiao Wang, Master

Conditions: Periodontitis, Human Dental Pulp Stem Cell