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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Changes from baseline in height of the periodontal bone defect [Срок оценки: at baseline, 90 days, 180 days]

Вторичные конечные точки (12)

• Changes from baseline in respiration rate of Vital Signs [Срок оценки: within 180 days after administration]
• Changes from baseline in heart rate of Vital Signs [Срок оценки: within 180 days after administration]
• Changes from baseline in blood pressure of Vital Signs [Срок оценки: within 180 days after administration]
• Changes from baseline in body temperature of Vital Signs [Срок оценки: within 180 days after administration]
• Changes from baseline in red blood cell count of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in white blood cell count of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in neutrophil count of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in lymphocyte count of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in platelet count of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in hemoglobin of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in PT of Laboratory Examination [Срок оценки: within 180 days after administration]
• Changes from baseline in INR of Laboratory Examination [Срок оценки: within 180 days after administration]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT05924373 · SH-hDP-MSC-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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