<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451486</url>
  </required_header>
  <id_info>
    <org_study_id>N201709009</org_study_id>
    <nct_id>NCT04451486</nct_id>
  </id_info>
  <brief_title>A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery</brief_title>
  <official_title>A Phase I Study to Evaluate The Use of Autologous-Derived Adult Peripheral Small Blood Stem Cells to Enhance Osseointegration of Guided Bone Regeneration in Implant Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to&#xD;
      enhance osseointegration of GBR in patients undergoing dental implant surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to&#xD;
      enhance osseointegration of GBR in patients undergoing dental implant surgery.&#xD;
&#xD;
      Enrolled subjects eligible to receive GBR procedure will be sequentially assigned to 1 of 3&#xD;
      treatment cohorts as follows:&#xD;
&#xD;
      Treatment dose 1 group：1×10*5 CD61-Lin- cells /0.25mL DPBS Treatment dose 2 group：1×10*6&#xD;
      CD61-Lin- cells /0.25mL DPBS Treatment dose 3 group：1×10*7 CD61-Lin- cells /0.25mL DPBS&#xD;
&#xD;
      After receiving the autologous SB cells solution mixed with 1 mL bone substitute, each first&#xD;
      treated subject at each cohort will be followed up to 4-weeks. After the first subject at&#xD;
      each cohort (3 subjects) complete a 4-weeks follow-up period, if investigator and sponsor&#xD;
      judge that there is not either a safety concern or a dose-limiting toxicity (DLT) criteria is&#xD;
      not met, 2 additional subjects within each cohort will be enrolled. A Data Safety Monitoring&#xD;
      Committee will be conveyed after the first 3 treated subjects at each cohort complete undergo&#xD;
      the dental implant procedure (12-weeks follow-up after GBR) to evaluate the safety and&#xD;
      preliminary efficacy of SB cells administered during a GBR procedure, and will provide&#xD;
      recommendations regarding study modification, continuation to enroll next subject(s), cohorts&#xD;
      or study termination.&#xD;
&#xD;
      If the committee recommends further subject enrollment, sequential recruitment will continue&#xD;
      until subjects for each treatment cohort are enrolled, treated and followed up to 24-weeks&#xD;
      after GBR (12-weeks after dental implant) unless there is a safety concern judged by&#xD;
      investigator, sponsor, or a dose-limiting toxicity (DLT) criteria is met. Once this situation&#xD;
      occurs, the committee will assess the progress and safety data of all subjects enrolled, and&#xD;
      will provide recommendations regarding study modification, continuation to enroll next&#xD;
      subject in that or other cohorts, or will recommend study termination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Anticipated">April 25, 2021</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Throughout the study, an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The maximum tolerated dose (MTD) of autologous-derived Small Blood Stem Cells in patients undergoing dental implant surgery.</measure>
    <time_frame>Throughout the study, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Guided Bone Regeneration</condition>
  <arm_group>
    <arm_group_label>Treatment dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1x10*5 CD61-Lin- cells /0.25mL DPBS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1x10*6 CD61-Lin- cells /0.25mL DPBS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1x10*7 CD61-Lin- cells /0.25mL DPBS</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB cells</intervention_name>
    <description>1x10*5 CD61-Lin- cells /0.25mL DPBS</description>
    <arm_group_label>Treatment dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB cells</intervention_name>
    <description>1x10*6 CD61-Lin- cells /0.25mL DPBS</description>
    <arm_group_label>Treatment dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB cells</intervention_name>
    <description>1x10*7 CD61-Lin- cells /0.25mL DPBS</description>
    <arm_group_label>Treatment dose 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects 20 years old and over;&#xD;
&#xD;
          2. Sign of informed consent form;&#xD;
&#xD;
          3. Patients with one missing tooth with D2, D3 bone density;&#xD;
&#xD;
          4. Gums environment defined as alveolar bone height of 10 mm and above, bone width 8 mm&#xD;
             and above;&#xD;
&#xD;
          5. Have only one missing maxillary or mandibular posterior tooth (No. 4, 5, 6 or 7) who&#xD;
             require a GBR prior to a dental implant.&#xD;
&#xD;
          6. Bone defect(s) must be present with at least two walls missing.&#xD;
&#xD;
          7. The opposing dentition must be nature teeth or fixed crowns or bridges on natural&#xD;
             teeth or implants. Removable prostheses or dentures opposing the study implants are&#xD;
             not allowed;&#xD;
&#xD;
          8. Subject is able to understand and comply with protocol requirements, instructions and&#xD;
             protocol stated restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have inadequate organ function described as below:&#xD;
&#xD;
               1. ANC &lt; 1.5 x 109/L&#xD;
&#xD;
               2. Platelets &lt; 100 x 109/L&#xD;
&#xD;
               3. Hb &lt; 9 g/dL&#xD;
&#xD;
               4. Serum bilirubin &lt; 1.5 x the upper limit of normal (ULN)&#xD;
&#xD;
               5. Aspartate aminotransferase (AST [SGOT]) &lt; 2.5 × the ULN&#xD;
&#xD;
               6. Alanine aminotransferase (ALT [SGPT]) &gt; 2.5 × the ULN&#xD;
&#xD;
               7. Serum creatinine &gt; 1.5 mg/dL or a measured creatinine clearance &lt; 60 mL/min;&#xD;
&#xD;
          2. History of neoplastic disease and had been treated with chemotherapy;&#xD;
&#xD;
          3. Uncontrolled Diabetes Mellitus;&#xD;
&#xD;
          4. Dialysis patients;&#xD;
&#xD;
          5. Patients with cardiovascular disease;&#xD;
&#xD;
          6. Osteoporosis patients and patients taking bisphosphonates;&#xD;
&#xD;
          7. History of radiation therapy to the head and neck;&#xD;
&#xD;
          8. Patients with temporomandibular disorder;&#xD;
&#xD;
          9. Pregnant or nursing women;&#xD;
&#xD;
         10. Presence of conditions requiring chronic routine prophylactic use of antibiotics&#xD;
             (history of rheumatic heart disease, bacterial endocarditis, cardiac valvular&#xD;
             anomalies, prosthetic joint replacements);&#xD;
&#xD;
         11. Medical conditions requiring prolonged use of steroids;&#xD;
&#xD;
         12. Physical handicaps that would interfere with the ability to perform adequate oral&#xD;
             hygiene;&#xD;
&#xD;
         13. Use of any investigational drug or device within the 30-day period immediately prior&#xD;
             to implant surgery on study day 0;&#xD;
&#xD;
         14. Alcoholism or drug abuse;&#xD;
&#xD;
         15. Patients infected with HIV;&#xD;
&#xD;
         16. Current smokers, ;&#xD;
&#xD;
         17. Local inflammation, including untreated periodontitis;&#xD;
&#xD;
         18. Mucosal diseases such as erosive lichen planus;&#xD;
&#xD;
         19. History of local radiation therapy;&#xD;
&#xD;
         20. Presence of osseous lesions;&#xD;
&#xD;
         21. Unhealed extraction sites;&#xD;
&#xD;
         22. Persistent intraoral infection;&#xD;
&#xD;
         23. Patients with inadequate oral hygiene or unmotivated for adequate home care;&#xD;
&#xD;
         24. Conditions or circumstances, in the opinion of the investigator, which would prevent&#xD;
             completion of study participation or interfere with analysis of study results, such as&#xD;
             history of non-compliance, or unreliability.&#xD;
&#xD;
         25. Patient with a pathology present near the site of dental implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Da-Yen Wang, PhD</last_name>
    <phone>+886-2-2736-1661</phone>
    <phone_ext>5401</phone_ext>
    <email>dpw1@tmu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sheng-Wei Feng, PhD</last_name>
    <phone>+886-2-2736-1661</phone>
    <phone_ext>5401</phone_ext>
    <email>shengwei@tmu.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Da-Yen Wang, PhD</last_name>
      <phone>+886-2-2736-1661</phone>
      <phone_ext>5401</phone_ext>
      <email>dpw1@tmu.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Sheng-Wei Feng, PhD</last_name>
      <phone>+886-2-2736-1661</phone>
      <phone_ext>5401</phone_ext>
      <email>shengwei@tmu.edu.tw</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Schneider R. Prosthetic concerns about atrophic alveolar ridges. Postgrad Dent. 1999;6(2):3-7.</citation>
    <PMID>11360322</PMID>
  </reference>
  <reference>
    <citation>de Baat C, Kalk W, van 't Hof M. Factors connected with alveolar bone resorption among institutionalized elderly people. Community Dent Oral Epidemiol. 1993 Oct;21(5):317-20. doi: 10.1111/j.1600-0528.1993.tb00783.x.</citation>
    <PMID>8222609</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SB cell、autologous、Osseointegration</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451486
org study id: N201709009
nct id: NCT04451486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to
      enhance osseointegration of GBR in patients undergoing dental implant surgery.
This is a Phase 1 study to evaluate the safety profile of autologous-derived SB cells to
      enhance osseointegration of GBR in patients undergoing dental implant surgery.

      Enrolled subjects eligible to receive GBR procedure will be sequentially assigned to 1 of 3
      treatment cohorts as follows:

      Treatment dose 1 group：1×10*5 CD61-Lin- cells /0.25mL DPBS Treatment dose 2 group：1×10*6
      CD61-Lin- cells /0.25mL DPBS Treatment dose 3 group：1×10*7 CD61-Lin- cells /0.25mL DPBS

      After receiving the autologous SB cells solution mixed with 1 mL bone substitute, each first
      treated subject at each cohort will be followed up to 4-weeks. After the first subject at
      each cohort (3 subjects) complete a 4-weeks follow-up period, if investigator and sponsor
      judge that there is not either a safety concern or a dose-limiting toxicity (DLT) criteria is
      not met, 2 additional subjects within each cohort will be enrolled. A Data Safety Monitoring
      Committee will be conveyed after the first 3 treated subjects at each cohort complete undergo
      the dental implant procedure (12-weeks follow-up after GBR) to evaluate the safety and
      preliminary efficacy of SB cells administered during a GBR procedure, and will provide
      recommendations regarding study modification, continuation to enroll next subject(s), cohorts
      or study termination.

      If the committee recommends further subject enrollment, sequential recruitment will continue
      until subjects for each treatment cohort are enrolled, treated and followed up to 24-weeks
      after GBR (12-weeks after dental implant) unless there is a safety concern judged by
      investigator, sponsor, or a dose-limiting toxicity (DLT) criteria is met. Once this situation
      occurs, the committee will assess the progress and safety data of all subjects enrolled, and
      will provide recommendations regarding study modification, continuation to enroll next
      subject in that or other cohorts, or will recommend study termination.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: Throughout the study, an average of 1 year
measure: The maximum tolerated dose (MTD) of autologous-derived Small Blood Stem Cells in patients undergoing dental implant surgery.
time frame: Throughout the study, an average of 1 year
arm group label: Treatment dose 1
arm group type: Experimental
description: 1x10*5 CD61-Lin- cells /0.25mL DPBS
arm group label: Treatment dose 2
arm group type: Experimental
description: 1x10*6 CD61-Lin- cells /0.25mL DPBS
arm group label: Treatment dose 3
arm group type: Experimental
description: 1x10*7 CD61-Lin- cells /0.25mL DPBS
intervention type: Drug
intervention name: SB cells
description: 1x10*5 CD61-Lin- cells /0.25mL DPBS
arm group label: Treatment dose 1
intervention type: Drug
intervention name: SB cells
description: 1x10*6 CD61-Lin- cells /0.25mL DPBS
arm group label: Treatment dose 2
intervention type: Drug
intervention name: SB cells
description: 1x10*7 CD61-Lin- cells /0.25mL DPBS
arm group label: Treatment dose 3
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Da-Yen Wang, PhD
phone: +886-2-2736-1661
phone ext: 5401
email: dpw1@tmu.edu.tw
last name: Sheng-Wei Feng, PhD
phone: +886-2-2736-1661
phone ext: 5401
email: shengwei@tmu.edu.tw
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
citation: Schneider R. Prosthetic concerns about atrophic alveolar ridges. Postgrad Dent. 1999;6(2):3-7.
PMID: 11360322
citation: de Baat C, Kalk W, van 't Hof M. Factors connected with alveolar bone resorption among institutionalized elderly people. Community Dent Oral Epidemiol. 1993 Oct;21(5):317-20. doi: 10.1111/j.1600-0528.1993.tb00783.x.
PMID: 8222609
responsible party type: Sponsor