PeriodontitisPhase 1NCT04983225
The Safety and Tolerability of Initial Periodontal Therapy Combined With Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis
A Phase 1 study testing Human Dental Pulp Stem Cells and Saline solution in people with Periodontitis, run by Peking University Third Hospital at 1 site in China.
Trial summary
The principal objective of this trial is to investigate the safety and tolerability of human dental pulp stem cells injection in the treatment of chronic periodontitis. The secondary objective is to provide the basis for dosage regimen for further clinical trials and to evaluate the preliminary efficacy. 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 Pulp Stem Cells and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2021to 31 Aug 2024
- Phase
- Phase 1
- 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
- 18 to 65 years old (including threshold ), unlimited gender.
- Radiological examination of the periodontal defect site shows vertical bone defect, and the probing depth (PD) is 4 to 8 mm.
- Voluntarily participate in the clinical study, understand and sign the informed consent, and comply with the relevant regulations during the study period and within 18 months after the end of the study.
Who cannot join
- Subjects with severe periodontal diseases (alveolar bone resorption generally exceeds two-thirds of the tooth root length) and affects the study tooth judgment;
- The grade of studied tooth looseness ≥ grade 2 (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement is grade 2; vertical loosening is grade 3);
- Subjects with surgical treatment of previous periodontal bone defect sites and adjacent periodontal tissues;
- Subjects with non-steroid anti-inflammatory drug, steroid hormone therapy, and/or hormone (except topical hormones) treatment, bisphosphonates within the previous 3 months before screening;
- Subjects with severe systemic infection within the previous 3 months before screening; or antibiotics treatment within 72 h before screening;
- Subjects with uncontrolled hypertension within 1 month before screening (defined as sitting systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg after receiving the optimal antihypertensive therapy);
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- Subjects with systemic diseases (including but not limited to: malignant tumor or with positive tumor examination during screening, diabetes, heart failure caused by heart disease, myocardial infarction within the first 6 months before screening, angina symptoms within the first 6 months before screening, and congenital heart disease, etc.);
- Subjects who are known to be allergic to any of the materials used in the treatment;
- Subjects with the allergic constitution and previous history of allergy to blood products;
- Laboratory test (any of them meets): abnormal liver function: ALT > 80 U/L or AST > 70 U/L; abnormal renal function: serum creatinine (picric acid method) > 97 μmol/L;
- Subjects with a bleeding tendency or coagulant dysfunction (INR ≥ 1.5 × ULN, or APTT ≥ 1.5 × ULN (except the ones who are receiving anticoagulant therapy)) or serious hematologic diseases (such as grade 3 or above anemia (Hb < 80 g/L); grade 2 or above thrombocytopenia ( < 75.0 × 109 /L))
- Viral serology positive (HBsAg, HCV antibody, HIV antibody, treponema pallidum antibody) positive;
- Subjects with unprotected sex within the previous 1 month before the screening;
- Pregnant or lactating women, or subjects with a positive result of β-HCG before the screening, or subjects who are unable or unwilling to take contraceptive measures under the investigator instruction;
- Women with oral contraceptives;
- Subjects with a history of smoking addiction in the previous 12 months before the screening (the number of cigarettes smoked per day ≥ 10);
- Subjects with mental or conscious disorders;
- Subjects who participated in other clinical studies within 3 months before the screening;
- Other circumstances deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Blank Controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Initial Periodontal Therapy Combined With Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis
The principal objective of this trial is to investigate the safety and tolerability of human dental pulp stem cells injection in the treatment of chronic periodontitis. The secondary objective is to provide the basis for dosage regimen for further clinical trials and to evaluate the preliminary efficacy.
Read the detailed description
Initial periodontal therapy involves cleaning, scaling and root planing. The present dose-escalating, randomized, double-blind, blank controlled clinical trial will be conducted to evaluate the safety and tolerability of dental pulp mesenchymal stem cells injection as an adjunct with Initial periodontal therapy in chronic periodontitis. Patients meeting the inclusion criteria will be assigned into five dose groups, in a 3:1 ratio within each group to treat with drug or placebo after initial periodontal therapy. The evaluation will be conducted based on safety and efficacy end points.
- Conditions
- Periodontitis
- Being tested
- Human Dental Pulp Stem Cells, Saline solution
- 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 Pulp Stem CellsDrug
Also called Initial periodontal therapy
Investigational drugs: based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), human dental pulp stem cell injection will be given for a single local injection;
Saline solutionOther
Also called Initial periodontal therapy
Blank control: initial Basal periodontal therapy (supragingival cleansing, subgingival scaling and root planning) followed by a single local injection of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| 1×10^6 cells/site group | Experimental | Human Dental Pulp Stem Cells Injection: 1×10^6 cells/periodontal defect site. Receives: Drug: Human Dental Pulp Stem Cells |
| 5×10^6 cells/site group | Experimental | Human Dental Pulp Stem Cells Injection: 5×10^6 cells/periodontal defect site. Receives: Drug: Human Dental Pulp Stem Cells |
| 1×10^7 cells/site group | Experimental | Human Dental Pulp Stem Cells Injection: 1×10^7 cells/periodontal defect site. Receives: Drug: Human Dental Pulp Stem Cells |
| 2×10^7 cells/two sites group | Experimental | Human Dental Pulp Stem Cells Injection: 1×10^7 cells/periodontal defect site, two locations in total, and the total cell injection volume is 2 × 10^7 cells/2 periodontal defect sites. Receives: Drug: Human Dental Pulp Stem Cells |
| 3~4×10^7 cells/three or four sites group | Experimental | Human Dental Pulp Stem Cells Injection: 1×10^7 cells/periodontal defect site, three or four locations in total, and the total cell injection volume is 3 × 10^7 to 4 × 10^7 cells/3 to 4 periodontal defect sites. Receives: Drug: Human Dental Pulp Stem Cells |
| Saline solution group | Placebo comparator | Saline solution: 0.6mL/periodontal defect site. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in respiration rate of Vital Signs.
Respiration rate in mg(μl)/(h·g)
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
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 CPR of Laboratory Examination
C-reactive protein (CPR) is a phylogenetically highly conserved plasma protein, changes of its plasma concentration（mg/L）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 stool form of Laboratory Examination
Stool form is classified by Bristol Stool Form Scale into 7 categories scored from 1 to 7; (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid.
Measured: within 180 days after administration.
Changes from baseline in stool white blood cells of Laboratory Examination
White blood cell count in stools is reported in the form of number.
Measured: within 180 days after administration.
Changes from baseline in stool red blood cells of Laboratory Examination
Red blood cell count in stools is reported in the form of number.
Measured: within 180 days after administration.
Changes from baseline in stool parasite egg of Laboratory Examination
Parasite egg count in stools is reported in the form of number.
Measured: within 180 days after administration.
Changes from baseline in stool OBT of Laboratory Examination
Changes of stool OBT will be examined by qualitative test (positive or negative).
Measured: within 180 days after administration.
Changes from baseline in ECG
The cardiac rhythm is showed in ECG 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.
Secondary outcomes (7)
Incidence of Treatment-Emergent Adverse Event
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events within 360 days and 720 days after administration, and the severity of adverse events is determined according to the NCI CTCAE version 5.0.
Measured: within 360 days and 720 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.
The clinical assessment requires the measurement of the distance from the free gingival margin (FGM) to the CEJ for each tooth surface. After this recording, AL may be calculated from the periodontal chart (i.e. PPD - distance CEJ to FGM). In cases with gingival recession, the distance FGM-CEJ turns negative and, hence, will be added to the PPD to determine AL.
Measured: at baseline, 90 days, 180 days ,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.
Measured: at baseline, 90 days, 180 days ,360 days, 720 days.
Change from baseline in Probing Bleeding Index （BI）
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 ,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.
Measured: at baseline, 90 days, 180 days ,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.
Measured: at baseline, 90 days, 180 days ,360 days, 720 days.
Changes from baseline in height of the periodontal bone defect and average density of alveolar ridge.
Changes in the height of the periodontal bone defect and the mean alveolar ridge density will be detected by Cone Beam Computed Tomography (CBCT)
Measured: at baseline, 90 days, 180 days ,360 days, 720 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start31 Jul 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT04983225
- Sponsor's protocol ID
- SH-hDP-MSC-101
- Status last verified
- May 2023
- First submitted
- 23 Jun 2021
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Blank Controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Initial Periodontal Therapy Combined With Human Dental Pulp Stem Cell Injection in the Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04983225
- Acronym / sponsor ID
- SH-hDP-MSC-101
- Conditions
- Periodontitis
- Keywords
- Human Dental Pulp Stem Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 30 Jul 2021 (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 principal objective of this trial is to investigate the safety and tolerability of human dental pulp stem cells injection in the treatment of chronic periodontitis. The secondary objective is to provide the basis for dosage regimen for further clinical trials and to evaluate the preliminary efficacy.
Detailed description
Initial periodontal therapy involves cleaning, scaling and root planing. The present dose-escalating, randomized, double-blind, blank controlled clinical trial will be conducted to evaluate the safety and tolerability of dental pulp mesenchymal stem cells injection as an adjunct with Initial periodontal therapy in chronic periodontitis. Patients meeting the inclusion criteria will be assigned into five dose groups, in a 3:1 ratio within each group to treat with drug or placebo after initial periodontal therapy. The evaluation will be conducted based on safety and efficacy end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1×10^6 cells/site group | Experimental | Drug: Human Dental Pulp Stem CellsHuman Dental Pulp Stem Cells Injection: 1×10^6 cells/periodontal defect site. |
| 5×10^6 cells/site group | Experimental | Drug: Human Dental Pulp Stem CellsHuman Dental Pulp Stem Cells Injection: 5×10^6 cells/periodontal defect site. |
| 1×10^7 cells/site group | Experimental | Drug: Human Dental Pulp Stem CellsHuman Dental Pulp Stem Cells Injection: 1×10^7 cells/periodontal defect site. |
| 2×10^7 cells/two sites group | Experimental | Drug: Human Dental Pulp Stem CellsHuman Dental Pulp Stem Cells Injection: 1×10^7 cells/periodontal defect site, two locations in total, and the total cell injection volume is 2 × 10^7 cells/2 periodontal defect sites. |
| 3~4×10^7 cells/three or four sites group | Experimental | Drug: Human Dental Pulp Stem CellsHuman Dental Pulp Stem Cells Injection: 1×10^7 cells/periodontal defect site, three or four locations in total, and the total cell injection volume is 3 × 10^7 to 4 × 10^7 cells/3 to 4 periodontal defect sites. |
| Saline solution group | Placebo comparator | Other: Saline solutionSaline solution: 0.6mL/periodontal defect site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years old (including threshold ), unlimited gender.
- Radiological examination of the periodontal defect site shows vertical bone defect, and the probing depth (PD) is 4 to 8 mm.
- Voluntarily participate in the clinical study, understand and sign the informed consent, and comply with the relevant regulations during the study period and within 18 months after the end of the study.
Key exclusion criteria (19 listed)
- Subjects with severe periodontal diseases (alveolar bone resorption generally exceeds two-thirds of the tooth root length) and affects the study tooth judgment;
- The grade of studied tooth looseness ≥ grade 2 (only buccolingual movement is defined as grade 1; buccolingual and mesiodistal movement is grade 2; vertical loosening is grade 3);
- Subjects with surgical treatment of previous periodontal bone defect sites and adjacent periodontal tissues;
- Subjects with non-steroid anti-inflammatory drug, steroid hormone therapy, and/or hormone (except topical hormones) treatment, bisphosphonates within the previous 3 months before screening;
- Subjects with severe systemic infection within the previous 3 months before screening; or antibiotics treatment within 72 h before screening;
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 Pulp Stem CellsAlso: Initial periodontal therapyInvestigational drugs: based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), human dental pulp stem cell injection will be given for a single local injection; | Drug | 1×10^6 cells/site group, 1×10^7 cells/site group, 2×10^7 cells/two sites group, 3~4×10^7 cells/three or four sites group, 5×10^6 cells/site group |
| Saline solutionAlso: Initial periodontal therapyBlank control: initial Basal periodontal therapy (supragingival cleansing, subgingival scaling and root planning) followed by a single local injection of normal saline. | Other | Saline solution group |
Primary outcome
Changes from baseline in respiration rate of Vital Signs.
Time frame: within 180 days after administration.
Respiration rate in mg(μl)/(h·g)
Changes from baseline in heart rate of Vital Signs.
Time frame: within 180 days after administration.
Heart rate in beats per minute
Changes from baseline in blood pressure of Vital Signs.
Time frame: within 180 days after administration.
Blood pressure in mmHg
Changes from baseline in body temperature of Vital Signs.
Time frame: within 180 days after administration.
Body temperature in Celsius degree
Changes from baseline in red blood cell count of Laboratory Examination
Time frame: within 180 days after administration.
Red blood cell count in whole blood is reported in the form of number.
Changes from baseline in white blood cell count of Laboratory Examination
Time frame: within 180 days after administration.
White blood cell count in whole blood is reported in the form of number.
Changes from baseline in neutrophil count of Laboratory Examination
Time frame: within 180 days after administration.
Neutrophil count in whole blood is reported in the form of number.
Changes from baseline in lymphocyte count of Laboratory Examination
Time frame: within 180 days after administration.
Lymphocyte count in whole blood is reported in the form of number.
Changes from baseline in platelet count of Laboratory Examination
Time frame: within 180 days after administration.
Platelet count in whole blood is reported in the form of number.
Changes from baseline in hemoglobin of Laboratory Examination
Time frame: within 180 days after administration.
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Changes from baseline in PT of Laboratory Examination
Time frame: within 180 days after administration.
Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Changes from baseline in INR of Laboratory Examination
Time frame: within 180 days after administration.
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.
Changes from baseline in APTT of Laboratory Examination
Time frame: within 180 days after administration.
Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.
Changes from baseline in total bilirubin of Laboratory Examination
Time frame: within 180 days after administration.
Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in direct bilirubin of Laboratory Examination
Time frame: within 180 days after administration.
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in ALT of Laboratory Examination
Time frame: within 180 days after administration.
Changes of ALT concentration (U/L) in serum will be recorded.
Changes from baseline in AST of Laboratory Examination
Time frame: within 180 days after administration.
Changes of AST concentration (U/L) in serum will be recorded.
Changes from baseline in total protein of Laboratory Examination
Time frame: within 180 days after administration.
Changes of total protein concentration (g/L) in serum will be recorded.
Changes from baseline in albumin of Laboratory Examination
Time frame: within 180 days after administration.
Changes of albumin concentration (g/L) in serum will be recorded.
Changes from baseline in total bile acid of Laboratory Examination
Time frame: within 180 days after administration.
Changes of total bile acid concentration (μmol/L) in serum will be recorded.
Changes from baseline in urea of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urea concentration (mmol/L) in serum will be recorded.
Changes from baseline in creatinine of Laboratory Examination
Time frame: within 180 days after administration.
Changes of creatinine concentration (μmol/L) in serum will be recorded.
Changes from baseline in uric acid of Laboratory Examination
Time frame: within 180 days after administration.
Changes of uric acid concentration (μmol/L) in serum will be recorded.
Changes from baseline in glucose of Laboratory Examination
Time frame: within 180 days after administration.
Changes of glucose concentration (mmol/L) in serum will be recorded.
Changes from baseline in potassium of Laboratory Examination
Time frame: within 180 days after administration.
Changes of potassium concentration (mmol/L) in serum will be recorded.
Changes from baseline in sodium of Laboratory Examination
Time frame: within 180 days after administration.
Changes of sodium concentration (mmol/L) in serum will be recorded.
Changes from baseline in chlorine of Laboratory Examination
Time frame: within 180 days after administration.
Changes of chlorine concentration (mmol/L) in serum will be recorded.
Changes from baseline in CPR of Laboratory Examination
Time frame: within 180 days after administration.
C-reactive protein (CPR) is a phylogenetically highly conserved plasma protein, changes of its plasma concentration（mg/L）will be recorded.
Changes from baseline in Detection of infectious diseases of Laboratory Examination
Time frame: within 180 days after administration.
It refers to infectious diseases screening.
Changes from baseline in IgA of Laboratory Examination
Time frame: within 180 days after administration.
Changes of IgA concentration （g/L）in serum will be recorded.
Changes from baseline in IgG of Laboratory Examination
Time frame: within 180 days after administration.
Changes of IgG concentration （g/L）in serum will be recorded.
Changes from baseline in IgM of Laboratory Examination
Time frame: within 180 days after administration.
Changes of IgM concentration （g/L）in serum will be recorded.
Changes from baseline in total IgE of Laboratory Examination
Time frame: within 180 days after administration.
Changes of total IgE concentration （g/L）in serum will be recorded.
Changes from baseline in Pregnancy test of Laboratory Examination
Time frame: within 180 days after administration.
Pregnancy test will be tested in female subjects
Changes from baseline in urine specific gravity of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine specific gravity will be recorded.
Changes from baseline in urine pH of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine pH value will be recorded.
Changes from baseline in urine glucose of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine glucose will be examined by qualitative test (positive or negative).
Changes from baseline in urine protein of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine protein will be examined by qualitative test (positive or negative).
Changes from baseline in urine ketone body of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine ketone body will be examined by qualitative test (positive or negative).
Changes from baseline in urine white blood cell of Laboratory Examination
Time frame: within 180 days after administration.
Changes of white blood cell in urine will be examined by qualitative test (positive or negative).
Changes from baseline in urine bilirubin of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine bilirubin will be examined by qualitative test (positive or negative).
Changes from baseline in urine occult blood of Laboratory Examination
Time frame: within 180 days after administration.
Changes of urine occult blood will be examined by qualitative test (positive or negative).
Changes from baseline in stool form of Laboratory Examination
Time frame: within 180 days after administration.
Stool form is classified by Bristol Stool Form Scale into 7 categories scored from 1 to 7; (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid.
Changes from baseline in stool white blood cells of Laboratory Examination
Time frame: within 180 days after administration.
White blood cell count in stools is reported in the form of number.
Changes from baseline in stool red blood cells of Laboratory Examination
Time frame: within 180 days after administration.
Red blood cell count in stools is reported in the form of number.
Changes from baseline in stool parasite egg of Laboratory Examination
Time frame: within 180 days after administration.
Parasite egg count in stools is reported in the form of number.
Changes from baseline in stool OBT of Laboratory Examination
Time frame: within 180 days after administration.
Changes of stool OBT will be examined by qualitative test (positive or negative).
Changes from baseline in ECG
Time frame: within 180 days after administration.
The cardiac rhythm is showed in ECG in the form of continuous curve. Changes of this continuous curve will be recorded.
Incidence of Treatment-Emergent Adverse Event
Time frame: within 180 days after administration.
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.
7 secondary outcomes
Incidence of Treatment-Emergent Adverse Event
Time frame: within 360 days and 720 days after administration
Change from baseline in Clinical Attachment Level (AL).
Time frame: at baseline, 90 days, 180 days ,360 days, 720 days.
Change from baseline in Probing Depth (PD).
Time frame: at baseline, 90 days, 180 days ,360 days, 720 days.
Change from baseline in Probing Bleeding Index （BI）
Time frame: at baseline, 90 days, 180 days ,360 days, 720 days.
Change from baseline in Gingival recession （GR）
Time frame: at baseline, 90 days, 180 days ,360 days, 720 days.
Change from baseline in Tooth Mobility (TM).
Time frame: at baseline, 90 days, 180 days ,360 days, 720 days.
Changes from baseline in height of the periodontal bone defect and average density of alveolar ridge.
Time frame: at baseline, 90 days, 180 days ,360 days, 720 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- 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 1 study testing Human Dental Pulp Stem Cells and Saline solution 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 3 inclusion and 19 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 31 May 2023. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in respiration rate of Vital Signs. (time frame: within 180 days after administration.). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.