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| Name | Class |
|---|---|
| Capital Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-dose group | Experimental | Human Dental Fulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in respiration rate of Vital Signs | Respiratory rate, in beats per minute | within 180 days after administration |
| Changes from baseline in heart rate of Vital Signs | Heart rate in beats per minute |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in interleukin-6 (IL-6) | Changes in IL-6 baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720 | at baseline, 90 days, 180 days，360 days，720 days |
| Change from baseline in tumor necrosis factor-alpha (TNF-α) |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Wang, Master | Contact | +86 010-82266334 | bysykqpeking@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Wang, Master | Department of Stomatology, Peking University Third Hospital, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijng | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40739139 | Derived | 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. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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multicenter, randomized, double-blind, parallel, placebo-controlled study
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double-blind
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| within 180 days after administration |
| Changes from baseline in blood pressure of Vital Signs | Blood pressure in mmHg, both systolic and diastolic blood pressure will be measured. | within 180 days after administration |
| Changes from baseline in body temperature of Vital Signs | Body temperature in Celsius degree | within 180 days after administration |
| Changes from baseline in red blood cell count of Laboratory Examination | Red blood cell count in whole blood is reported in the form of number | within 180 days after administration |
| Changes from baseline in white blood cell count of Laboratory Examination | White blood cell count in whole blood is reported in the form of number | within 180 days after administration |
| Changes from baseline in neutrophil count of Laboratory Examination | Neutrophil count in whole blood is reported in the form of number | within 180 days after administration |
| Changes from baseline in lymphocyte count of Laboratory Examination | Lymphocyte count in whole blood is reported in the form of number | within 180 days after administration |
| Changes from baseline in platelet count of Laboratory Examination | Platelet count in whole blood is reported in the form of number | within 180 days after administration |
| Changes from baseline in hemoglobin of Laboratory Examination | Changes of hemoglobin concentration（g/dL）in whole blood will be recorded. | within 180 days after administration |
| Changes from baseline in PT of Laboratory Examination | Prothrombin time (PT) is a screening test for exogenous coagulation factors | within 180 days after administration |
| Changes from baseline in INR of Laboratory Examination | International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent. | within 180 days after administration |
| Changes from baseline in APTT of Laboratory Examination | Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors | within 180 days after administration |
| Changes from baseline in total bilirubin of Laboratory Examination | Changes of total bilirubin concentration (μmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in direct bilirubin of Laboratory Examination | Changes of direct bilirubin concentration (μmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in ALT of Laboratory Examination | Changes of ALT concentration (U/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in AST of Laboratory Examination | Changes of AST concentration (U/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in total protein of Laboratory Examination | Changes of total protein concentration (g/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in albumin of Laboratory Examination | Changes of albumin concentration (g/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in total bile acid of Laboratory Examination | Changes of total bile acid concentration (μmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in urea of Laboratory Examination | Changes of urea concentration (mmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in creatinine of Laboratory Examination | Changes of creatinine concentration (μmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in uric acid of Laboratory Examination | Changes of uric acid concentration (μmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in glucose of Laboratory Examination | Changes of glucose concentration (mmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in potassium of Laboratory Examination | Changes of potassium concentration (mmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in sodium of Laboratory Examination | Changes of sodium concentration (mmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in chlorine of Laboratory Examination | Changes of chlorine concentration (mmol/L) in serum will be recorded | within 180 days after administration |
| Changes from baseline in Detection of infectious diseases of Laboratory Examination | It refers to infectious diseases screening | within 180 days after administration |
| Changes from baseline in IgA of Laboratory Examination | Changes of IgA concentration （g/L）in serum will be recorded | within 180 days after administration |
| Changes from baseline in IgG of Laboratory Examination | Changes of IgG concentration （g/L）in serum will be recorded | within 180 days after administration |
| Changes from baseline in IgM of Laboratory Examination | Changes of IgM concentration （g/L）in serum will be recorded | within 180 days after administration |
| Changes from baseline in total IgE of Laboratory Examination | Changes of total IgE concentration （g/L）in serum will be recorded | within 180 days after administration |
| Changes from baseline in Pregnancy test of Laboratory Examination | Pregnancy test will be tested in female subjects | within 180 days after administration |
| Changes from baseline in urine specific gravity of Laboratory Examination | Changes of urine specific gravity will be recorded | within 180 days after administration |
| Changes from baseline in urine pH of Laboratory Examination | Changes of urine pH value will be recorded | within 180 days after administration |
| Changes from baseline in urine glucose of Laboratory Examination | Changes of urine glucose will be examined by qualitative test (positive or negative) | within 180 days after administration |
| Changes from baseline in urine protein of Laboratory Examination | Changes of urine protein will be examined by qualitative test (positive or negative) | within 180 days after administration |
| Changes from baseline in urine ketone body of Laboratory Examination | Changes of urine ketone body will be examined by qualitative test (positive or negative) | within 180 days after administration |
| Changes from baseline in urine white blood cell of Laboratory Examination | Changes of white blood cell in urine will be examined by qualitative test (positive or negative) | within 180 days after administration |
| Changes from baseline in urine bilirubin of Laboratory Examination | Changes of urine bilirubin will be examined by qualitative test (positive or negative) | within 180 days after administration |
| Changes from baseline in urine occult blood of Laboratory Examination | Changes of urine occult blood will be examined by qualitative test (positive or negative) | within 180 days after administration |
| Changes from baseline in ECG PR interval | The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded. | within 180 days after administration |
| Changes from baseline in ECG QRS interval | The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded. | within 180 days after administration |
| Changes from baseline in ECG RR interval | The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded. | within 180 days after administration |
| Changes from baseline in ECG QT interval | The cardiac rhythm is showed in 12 Leads Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded. | within 180 days after administration |
| Incidence of Treatment-Emergent Adverse Event | Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events during the study period, and the severity of adverse events is determined according to the NCI CTCAE version 5.0 | within 180 days after administration |
| Change from baseline in Clinical Attachment Level (AL) | Clinical Attachment Level (AL) may be assessed to the nearest millimeter by means of a graduated probe and expressed as the distance in millimeters from the CEJ to the bottom of the probeable gingival/periodontal pocket | at baseline, 90 days, 180 days |
| Change from baseline in Tooth Mobility (TM) | The continuous loss of the supporting tissues during periodontal disease progression may result in increased tooth mobility, which is divided into 3 degree: I°, II°, and III°. Changes from baseline in tooth mobility will be recorded | at baseline, 90 days, 180 days |
| Change from baseline in Probing Depth (PD) | The probing depth is the distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured to the nearest millimeter by means of periodontal probe | at baseline, 90 days, 180 days |
| Change from baseline in Gingival recession （GR） | Exposure of the tooth through apical migration of the gingiva is called gingival recession. Recorded as the distance in millimeters from the CEJ to the gingival margin | at baseline, 90 days, 180 days |
| Change from baseline in Probing bleeding on probing (BOP) | A periodontal probe is inserted to the "bottom" of the gingival/periodontal pocket applying light force and is moved gently along the tooth (root) surface. If bleeding is provoked by this examination, the site examined is considered bleeding on probing-positive and, hence, inflamed. Probing Bleeding Index is divided into 5 grades: 0, 1, 2, 3 and 4. | at baseline, 90 days, 180 days |
Changes in TNF-α baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720 |
| at baseline, 90 days, 180 days，360 days，720 days |
| Change from baseline in matrix metalloproteinase-8 (MMP-8) | Changes in MMP-8 baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720 | at baseline, 90 days, 180 days，360 days，720 days |
| Change from baseline in interleukin-1beta (IL-1β) | Changes in IL-1β baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720 | at baseline, 90 days, 180 days，360 days，720 days |
| Change from baseline in osteoprotegerin (OPG) | Changes in OPG baseline will be confirmed through gingival crevicular fluid detection at D90 D180 D360 and D720 | at baseline, 90 days, 180 days，360 days，720 days |
| 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 D360 and D720 | at baseline, 360 days，720 days |
| Change from baseline in Clinical Attachment Level (AL) | Clinical Attachment Level (AL) may be assessed to the nearest millimeter by means of a graduated probe and expressed as the distance in millimeters from the CEJ to the bottom of the probeable gingival/periodontal pocket | at baseline, 360 days，720 days |
| Change from baseline in Probing Depth (PD) | The probing depth is the distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured to the nearest millimeter by means of periodontal probe | at baseline, 360 days，720 days |
| Change from baseline in Tooth Mobility (TM) | The continuous loss of the supporting tissues during periodontal disease progression may result in increased tooth mobility, which is divided into 3 degree: I°, II°, and III°. Changes from baseline in tooth mobility will be recorded | at baseline, 360 days，720 days |
| Change from baseline in Gingival recession （GR） | Exposure of the tooth through apical migration of the gingiva is called gingival recession. Recorded as the distance in millimeters from the CEJ to the gingival margin | at baseline, 360 days，720 days |
| Change from baseline in Probing bleeding on probing (BOP) | A periodontal probe is inserted to the "bottom" of the gingival/periodontal pocket applying light force and is moved gently along the tooth (root) surface. If bleeding is provoked by this examination, the site examined is considered bleeding on probing-positive and, hence, inflamed. Probing Bleeding Index is divided into 5 grades: 0, 1, 2, 3 and 4. | at baseline, 360 days，720 days |