PeriodontitisPhase 2NCT05924373
Human Dental Pulp Mesenchymal Stem Cells for the Treatment of Chronic Periodontitis Patients
A Phase 2 study testing Human Dental Fulp Stem Cells in people with Periodontitis, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Human Dental Fulp Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijng, 100191
Meng Wan, doctor, +86 010-82266263, wanmengpeking@126.com
About this study
Official title: 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.
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.
Read the detailed 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.
- Conditions
- Periodontitis
- Being tested
- Human Dental Fulp Stem Cells
- Keywords
- Human Dental Pulp Stem Cell
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Dental Fulp Stem CellsDrug
Also called Initial periodontal therapy
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
| Study group | Role | What they receive |
|---|---|---|
| single-dose group | Experimental | Human Dental Fulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site. Receives: 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. Receives: 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. Receives: Drug: Human Dental Fulp Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at baseline, 90 days, 180 days
Secondary outcomes (51)
Changes from baseline in respiration rate of Vital Signs
Respiratory rate, in beats per minute
Measured: within 180 days after administration
Changes from baseline in heart rate of Vital Signs
Heart rate in beats per minute
Measured: 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.
Measured: within 180 days after administration
Changes from baseline in body temperature of Vital Signs
Body temperature in Celsius degree
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: within 180 days after administration
Changes from baseline in PT of Laboratory Examination
Prothrombin time (PT) is a screening test for exogenous coagulation factors
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: within 180 days after administration
Changes from baseline in ALT of Laboratory Examination
Changes of ALT concentration (U/L) in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in AST of Laboratory Examination
Changes of AST concentration (U/L) in serum will be recorded
Measured: 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
Measured: within 180 days after administration
Changes from baseline in albumin of Laboratory Examination
Changes of albumin concentration (g/L) in serum will be recorded
Measured: 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
Measured: within 180 days after administration
Changes from baseline in urea of Laboratory Examination
Changes of urea concentration (mmol/L) in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in creatinine of Laboratory Examination
Changes of creatinine concentration (μmol/L) in serum will be recorded
Measured: 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
Measured: within 180 days after administration
Changes from baseline in glucose of Laboratory Examination
Changes of glucose concentration (mmol/L) in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in potassium of Laboratory Examination
Changes of potassium concentration (mmol/L) in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in sodium of Laboratory Examination
Changes of sodium concentration (mmol/L) in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in chlorine of Laboratory Examination
Changes of chlorine concentration (mmol/L) in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in Detection of infectious diseases of Laboratory Examination
It refers to infectious diseases screening
Measured: within 180 days after administration
Changes from baseline in IgA of Laboratory Examination
Changes of IgA concentration （g/L）in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in IgG of Laboratory Examination
Changes of IgG concentration （g/L）in serum will be recorded
Measured: within 180 days after administration
Changes from baseline in IgM of Laboratory Examination
Changes of IgM concentration （g/L）in serum will be recorded
Measured: 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
Measured: within 180 days after administration
Changes from baseline in Pregnancy test of Laboratory Examination
Pregnancy test will be tested in female subjects
Measured: within 180 days after administration
Changes from baseline in urine specific gravity of Laboratory Examination
Changes of urine specific gravity will be recorded
Measured: within 180 days after administration
Changes from baseline in urine pH of Laboratory Examination
Changes of urine pH value will be recorded
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: at baseline, 90 days, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start27 Nov 2023
- Primary completion7 Mar 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, double-blind, parallel, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Sponsor
- Investigators
- Xiao Wang, Master, Principal investigator, Department of Stomatology, Peking University Third Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924373
- Sponsor's protocol ID
- SH-hDP-MSC-102
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40739139
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05924373
- Acronym / sponsor ID
- SH-hDP-MSC-102
- Conditions
- Periodontitis
- Keywords
- Human Dental Pulp Stem Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- multicenter, randomized, double-blind, parallel, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| single-dose group | Experimental | Drug: Human Dental Fulp Stem CellsHuman Dental Fulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site. |
| two-dose group (low-dose) | Experimental | Drug: Human Dental Fulp Stem CellsHuman 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 | Drug: Human Dental Fulp Stem CellsHuman Dental Pulp Stem Cells Injection: 1X 10^7 cells/periodontaldefect site. Continuous administration twice, with an interval of 89 days between each administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (16 listed)
- Participants are excluded from the study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Dental Fulp Stem CellsAlso: Initial periodontal therapyInvestigational 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 | Drug | single-dose group, two-dose group (high-dose), two-dose group (low-dose) |
Primary outcome
Changes from baseline in height of the periodontal bone defect
Time frame: at baseline, 90 days, 180 days
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)
51 secondary outcomes
Changes from baseline in respiration rate of Vital Signs
Time frame: within 180 days after administration
Changes from baseline in heart rate of Vital Signs
Time frame: within 180 days after administration
Changes from baseline in blood pressure of Vital Signs
Time frame: within 180 days after administration
Changes from baseline in body temperature of Vital Signs
Time frame: within 180 days after administration
Changes from baseline in red blood cell count of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in white blood cell count of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in neutrophil count of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in lymphocyte count of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in platelet count of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in hemoglobin of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in PT of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in INR of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in APTT of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in total bilirubin of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in direct bilirubin of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in ALT of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in AST of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in total protein of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in albumin of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in total bile acid of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urea of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in creatinine of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in uric acid of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in glucose of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in potassium of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in sodium of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in chlorine of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in Detection of infectious diseases of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in IgA of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in IgG of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in IgM of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in total IgE of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in Pregnancy test of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine specific gravity of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine pH of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine glucose of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine protein of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine ketone body of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine white blood cell of Laboratory Examination
Time frame: within 180 days after administration
Changes from baseline in urine bilirubin of Laboratory Examination
Time frame: within 180 days after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 40739139Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Wang, Master principal investigator
Department of Stomatology, Peking University Third Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Dental Fulp Stem Cells in people with Periodontitis, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Wang, Master (+86 010-82266334, bysykqpeking@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in height of the periodontal bone defect (time frame: at baseline, 90 days, 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05924373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.