[Translation] A randomized, double-blind, parallel, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of local injection of human dental pulp mesenchymal stem cells in the treatment of patients with chronic periodontitis

主要目的：评估人牙髓间充质干细胞不同给药方案对慢性牙周炎治疗的有效性。次要目的：评估人牙髓间充质干细胞不同给药方案对慢性牙周炎治疗的安全性。探索性目的：探索人牙髓间充质干细胞对慢性牙周炎患者龈沟液生物标志物的影响。

[Translation]

Primary purpose: To evaluate the effectiveness of different dosing regimens of human dental pulp mesenchymal stem cells in the treatment of chronic periodontitis. Secondary purpose: To evaluate the safety of different dosing regimens of human dental pulp mesenchymal stem cells in the treatment of chronic periodontitis. Exploratory purpose: To explore the effect of human dental pulp mesenchymal stem cells on gingival crevicular fluid biomarkers in patients with chronic periodontitis.

Start Date13 Nov 2023

Sponsor / Collaborator

Capital University of Medical Sciences

[+1]

CTR20212030 / Active, not recruitingPhase 1

注射用重组新蛭素（酵母）治疗非ST段抬高急性冠状动脉综合征（NSTE-ACS）的安全性、耐受性、药代动力学及药效学研究

[Translation] Safety, tolerability, pharmacokinetics and pharmacodynamics of recombinant hirudin (yeast) for injection in the treatment of non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

1.考察不同剂量的注射用重组新蛭素（酵母）用于治疗NSTE-ACS的耐受性和安全性； 2.探索不同剂量的注射用重组新蛭素（酵母）用于治疗NSTE-ACS的药代动力学特征及药效学特征；

[Translation]

1. To investigate the tolerability and safety of different doses of recombinant new hirudin (yeast) for injection in the treatment of NSTE-ACS; 2. To explore the pharmacokinetic and pharmacodynamic characteristics of different doses of recombinant new hirudin (yeast) for injection in the treatment of NSTE-ACS;

Start Date15 Oct 2021

Sponsor / Collaborator

Beijing Sanyouli Heze Biological Technology Co. Ltd.

[+1]

CTR20211389 / Active, not recruitingPhase 1

牙周基础治疗联合人牙髓间充质干细胞注射液治疗慢性牙周炎的随机、双盲、剂量递增、（空白）对照的安全性、耐受性临床试验

[Translation] A randomized, double-blind, dose-escalation, (blank)-controlled safety and tolerability clinical trial of periodontal basic therapy combined with human dental pulp mesenchymal stem cell injection in the treatment of chronic periodontitis

主要目的：探索人牙髓间充质干细胞治疗慢性牙周炎的安全性和耐受性。次要目的：剂量探索，为后续临床研究的给药方案提供设计依据；探索人牙髓间充质干细胞治疗慢性牙周炎的初步有效性。

[Translation]

Main purpose: To explore the safety and tolerability of human dental pulp mesenchymal stem cells in the treatment of chronic periodontitis. Secondary purpose: To explore the dose, to provide a design basis for the dosing regimen of subsequent clinical studies; to explore the preliminary effectiveness of human dental pulp mesenchymal stem cells in the treatment of chronic periodontitis.

Start Date31 Jul 2021

Sponsor / Collaborator

Capital University of Medical Sciences

[+1]

100 Clinical Results associated with Beijing Sanyouli Heze Biological Technology Co. Ltd.

0 Patents (Medical) associated with Beijing Sanyouli Heze Biological Technology Co. Ltd.

Literatures (Medical) associated with Beijing Sanyouli Heze Biological Technology Co. Ltd.

01 Jan 2023·Drug design, development and therapy

Recombinant Neorudin for the Prevention of Deep-Vein Thrombosis After Spinal-Cord Injury.

Article

Author: Zhou, Gang-Qiao ; Xia, Xia ; Wu, Chu-Tse ; Ren, Bo-Yuan ; Liu, Yu-Bin ; Zheng, Can ; Wang, Wei-Ting ; Hao, Chun-Hua ; Liu, Yun ; Zhang, Lin ; Zhou, Xing-Chen ; Jin, Ji-De

BackgroundWhether anticoagulant therapy should be used after spinal-cord injury (SCI) surgery was controversial. The anticoagulation characteristics of a newly developed anticoagulant, recombinant neorudin (EPR-hirudin (EH)), were explored using a rat model of SCI to provide a basis for clinical anticoagulation therapy of SCI.MethodsA rat model of SCI was developed by Allen's method. Then, thrombosis in the inferior vena cava was induced by ligation. The low-bleeding characteristics of EH were explored by investigating dose-response and time-effect relationships, as well as multiple administration of EH, on thrombus formation complicated with SCI.ResultsEH inhibited thrombosis in a dose-dependent manner by reducing the wet weight and dry weight of the thrombus. An inhibiting action of EH on thrombosis was most evident in the group given EH 2 h after SCI. After multiple intravenous doses of EH, thrombosis inhibition was improved to that observed with low molecular weight heparin (LMWH) (87% vs 90%). EH administration after SCI neither increased bleeding in the injured spine nor damaged to nerve function. Bleeding duration and activated partial thromboplastin time were increased in the high-dose EH group compared with that in the normal-saline group, but were lower than those in the LMWH group.ConclusionEH can reduce thrombus formation in a rat model of SCI, and bleeding is decreased significantly compared with that using LMWH. EH may prevent thrombosis after SCI or spinal surgery.

31 Aug 2021·Stem Cells InternationalQ3 · MEDICINE

Dental Pulp Mesenchymal Stem Cells Attenuate Limb Ischemia via Promoting Capillary Proliferation and Collateral Development in a Preclinical Model

Q3 · MEDICINE

ArticleOA

Author: Wu, Chu-tse ; Sun, Chengfeng ; Yang, Yuefeng ; Liu, Hongying ; He, Jia ; Wang, Hua ; Liu, Dongmei ; Jiang, Xi ; Li, Youfeng ; Wang, Weiting ; Zhang, Yuning ; Chen, Furong

Critical limb ischemia (CLI), an end-stage manifestation of peripheral artery disease (PAD), still lacks effective therapeutic strategies. Recently, dental pulp-derived mesenchymal stem cells (DP-MSCs) have been attracting more and more attentions in therapeutic applications due to their high proliferation ability, powerful osteogenic differentiation potential, and effective anti-inflammatory effects. In this study, we compared the therapeutic effects of MSCs derived from different sources in a femoral artery-ligated preclinical ischemic model. We found that treatments with MSCs, including bone marrow- (BM-), adipose- (AD-), dental pulp- (DP-), and umbilical cord- (UC-) derived MSCs, improved limb functions, reduced inflammatory responses, increased angiogenesis, and promoted regeneration of muscle fiber. Among them, DP-MSCs and BM-MSCs produced much more impressive effects in restoring limb functions and promoting angiogenesis. The flow velocity restored to nearly 20% of the normal level at 3 weeks after treatments with DP-MSCs and BM-MSCs, and obvious capillary proliferation and collateral development could be observed. Although neovascularization was induced in the ischemic limb after ligation, MSCs, especially DP-MSCs, significantly enhanced the angiogenesis. In vitro experiments showed that serum deprivation improved the expression of angiogenic factors, growth factors, and chemokines in DP-MSCs and UC-MSCs, but not in BM-MSCs and AD-MSCs. However, DP-MSCs produced stronger therapeutic responses than UC-MSCs, which might be due to the higher expression of hepatocyte growth factor (HGF) and hypoxia-inducible factor-1 α (HIF-1α). We speculated that DP-MSCs might stimulate angiogenesis and promote tissue repair via expressing and secreting angiogenic factors, growth factors, and chemokines, especially HGF and HIF-1α. In conclusion, DP-MSCs might be a promising approach for treating CLI.

01 Dec 2020·Trials

Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II)

Letter

Author: Yehenala, Jun ; Zhang, Zhan ; Liu, Zhiming ; He, Yan ; Zhou, Chenliang ; Wang, Hua ; Ye, Qingsong ; Wang, Si ; Zhou, Gangqiao ; Zhao, Yang ; Wu, Bin ; Xia, Zun-En ; Wu, Chu-Tse ; Xia, Xia ; Hu, Ke ; Wang, Songling

AbstractObjectivesTo assess the safety and therapeutic effects of allogeneic human dental pulp stem cells (DPSCs) in treating severe pneumonia caused by COVID-19.Trial designThis is a single centre, two arm ratio 1:1, triple blinded, randomized, placebo-controlled, parallel group, clinical trial.ParticipantsTwenty serious COVID-19 cases will be enrolled in the trial from April 6th to December 31st 2020. Inclusion Criteria: hospitalised patients at Renmin Hospital of Wuhan University satisfy all criteria as below:

Adults aged 18-65 years;

Voluntarily participate in this clinical trial and sign the “informed consent form” or have consent from a legal representative.

Diagnosed with severe pneumonia of COVID-19: nucleic acid test SARS-CoV-2 positive; respiratory distress (respiratory rate > 30 times / min); hypoxia (resting oxygen saturation < 93% or arterial partial pressure of oxygen / oxygen concentration < 300 mmHg).

COVID-19 featured lung lesions in chest X-ray image.

Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria.

Patients have received other experimental treatment for COVID-19 within the last 30 days;

Patients have severe liver condition (e.g., Child Pugh score >=C or AST> 5 times of the upper limit);

Patients with severe renal insufficiency (estimated glomerular filtration rate <=30mL / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis;

Patients who are co-infected with HIV, hepatitis B, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses;

Female patients who have no sexual protection in the last 30 days prior to the screening assessment;

Pregnant or lactating women or women using estrogen contraception;

Patients who are planning to become pregnant during the study period or within 6 months after the end of the study period;

Other conditions that the researchers consider not suitable for participating in this clinical trial.

Intervention and comparatorThere will be two study groups: experimental and control. Both will receive all necessary routine treatment for COVID-19.The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x107 human DPSCs in 30ml saline solution) on day 1, 4 and 7;The control group will receive an equal amount of saline (placebo) on the same days.Clinical and laboratory observations will be performed for analysis during a period of 28 days for each case since the commencement of the study.Main outcomes1. Primary outcomeThe primary outcome is Time To Clinical Improvement (TTCI). By definition, TTCI is the time (days) it takes to downgrade two levels from the following six ordered grades [(grade 1) discharge to (grade 6) death] in the clinical state of admission to the start of study treatments (hDPSCs or placebo).Six grades of ordered variables: GradeDescriptionGrade 1:Discharged of patient;Grade 2:Hospitalized without oxygen supplement;Grade 3:Hospitalized, oxygen supplement is required, but NIV / HFNC is not required;Grade 4:Hospitalized in intensive care unit, and NIV / HFNC treatment is required;Grade 5:Hospitalized in intensive care unit, requiring ECMO and/or IMV;Grade 6:Death.

Abbreviations: NIV, non-invasive mechanical ventilation; HFNC, high-flow nasal catheter; IMV, invasive mechanical ventilation.

2. Secondary outcomes2.1 vital signs: heart rate, blood pressure (systolic blood pressure, diastolic blood pressure). During the screening period, hospitalization every day (additional time points of D1, D4, D7 30min before injection, 2h ± 30min, 24h ± 30min after the injection) and follow-up period D90 ± 3 days.2.2 Laboratory examinations: during the screening period, 30 minutes before D1, D4, D7 infusion, 2h ± 30min, 24h ± 30min after the end of infusion, D10, D14, D28 during hospitalization or discharge day and follow-up period D90 ± 3 days.2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets;2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate.2.5 Inflammation indicators: hypersensitive C-reactive protein, serum amyloid (SAA);2.6 Infectious disease testing: Hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), Hepatitis C (Anti-HCV), AIDS (HIVcombin), syphilis (Anti-TP), cytomegalovirus CMV-IgM, cytomegalovirus CMV-IgG; only during the screening period and follow-up period D90 ± 3.2.7 Immunological testing:Collect peripheral blood to detect the phenotype of T lymphocyte, B lymphocyte, natural killer cell, Macrophage and neutrophil by using flow cytometry.Collect peripheral blood to detect the gene profile of mononuclear cells by using single-cell analyses.Collect peripheral blood serum to detect various immunoglobulin changes: IgA, IgG, IgM, total IgE;Collect peripheral blood serum to explore the changes of cytokines, Th1 cytokines (IL-1 β, IL-2, TNF-a, ITN-γ), Th2 cytokines (IL-4, IL-6, IL -10).2.8 Pregnancy test: blood β-HCG, female subjects before menopause are examined during the screening period and follow-up period D90 ± 3.2.9 Urine routine: color, clarity, urine sugar, bilirubin, ketone bodies, specific gravity, pH, urobilinogen, nitrite, protein, occult blood, leukocyte enzymes, red blood cells, white blood cells, epithelial cells, non-squamous epithelial cells , Transparent cast, pathological cast, crystal, fungus;2.10 Stool Routine: color, traits, white blood cells, red blood cells, fat globules, eggs of parasites, fungi, occult blood (chemical method), occult blood (immune method), transferrin (2h ± 30min after the injection and not detected after discharge).RandomizationBlock randomization method will be applied by computer to allocate the participants into experimental and control groups. The random ratio is 1:1.Blinding (masking)Participants, outcomes assessors and investigators (including personnel in laboratory and imaging department who issue the sample report or image observations) will be blinded.Injections of cell suspension and saline will be coded in accordance with the patient’s randomisation group.The blind strategy is kept by an investigator who does not deliver the medical care or assess primary outcome results.Numbers to be randomized (sample size)Twenty participants will be randomized to the experimental and control groups (10 per group).Trial StatusProtocol version number, hDPSC-CoVID-2019-02-2020 Version 2.0, March 13, 2020.Patients screening commenced on 16th April and an estimated date of the recruitment of the final participants will be around end of July. .Trial registrationRegistration:World Health Organization Trial Registry: ChiCTR2000031319; March 27,2020.ClinicalTrials.gov Identifier: NCT04336254; April 7, 2020Other Study ID Numbers: hDPSC-CoVID-2019-02-2020Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

100 Deals associated with Beijing Sanyouli Heze Biological Technology Co. Ltd.

100 Translational Medicine associated with Beijing Sanyouli Heze Biological Technology Co. Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Allogeneic dental pulp mesenchymal stem cell therapy (Beijing SH Bio-Tech Corporation/Utooth Biological Technology)	Chronic Periodontitis More	Phase 2
EH(Beijing SH Bio-Tech) ( prothrombin )	Non ST segment elevation acute coronary syndrome More	Phase 1
CD19 CAR-T (Beijing Sanyouli Heze Biological Technology) ( CD19 )	Acute Lymphoblastic Leukemia More	Phase 1

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