Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04451486
Other study ID # N201709009
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 10, 2018
Est. completion date April 25, 2021

Study information

Verified date June 2020
Source Taipei Medical University
Contact Da-Yen Wang, PhD
Phone +886-2-2736-1661
Email dpw1@tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date April 25, 2021
Est. primary completion date December 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Subjects 20 years old and over;

2. Sign of informed consent form;

3. Patients with one missing tooth with D2, D3 bone density;

4. Gums environment defined as alveolar bone height of 10 mm and above, bone width 8 mm and above;

5. Have only one missing maxillary or mandibular posterior tooth (No. 4, 5, 6 or 7) who require a GBR prior to a dental implant.

6. Bone defect(s) must be present with at least two walls missing.

7. The opposing dentition must be nature teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed;

8. Subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions

Exclusion Criteria:

1. Patients who have inadequate organ function described as below:

1. ANC < 1.5 x 109/L

2. Platelets < 100 x 109/L

3. Hb < 9 g/dL

4. Serum bilirubin < 1.5 x the upper limit of normal (ULN)

5. Aspartate aminotransferase (AST [SGOT]) < 2.5 × the ULN

6. Alanine aminotransferase (ALT [SGPT]) > 2.5 × the ULN

7. Serum creatinine > 1.5 mg/dL or a measured creatinine clearance < 60 mL/min;

2. History of neoplastic disease and had been treated with chemotherapy;

3. Uncontrolled Diabetes Mellitus;

4. Dialysis patients;

5. Patients with cardiovascular disease;

6. Osteoporosis patients and patients taking bisphosphonates;

7. History of radiation therapy to the head and neck;

8. Patients with temporomandibular disorder;

9. Pregnant or nursing women;

10. Presence of conditions requiring chronic routine prophylactic use of antibiotics (history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements);

11. Medical conditions requiring prolonged use of steroids;

12. Physical handicaps that would interfere with the ability to perform adequate oral hygiene;

13. Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0;

14. Alcoholism or drug abuse;

15. Patients infected with HIV;

16. Current smokers, ;

17. Local inflammation, including untreated periodontitis;

18. Mucosal diseases such as erosive lichen planus;

19. History of local radiation therapy;

20. Presence of osseous lesions;

21. Unhealed extraction sites;

22. Persistent intraoral infection;

23. Patients with inadequate oral hygiene or unmotivated for adequate home care;

24. Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

25. Patient with a pathology present near the site of dental implantation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SB cells
1x10*5 CD61-Lin- cells /0.25mL DPBS
SB cells
1x10*6 CD61-Lin- cells /0.25mL DPBS
SB cells
1x10*7 CD61-Lin- cells /0.25mL DPBS

Locations

Country Name City State
Taiwan Taipei Medical University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

Schneider R. Prosthetic concerns about atrophic alveolar ridges. Postgrad Dent. 1999;6(2):3-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events Throughout the study, an average of 1 year
Secondary The maximum tolerated dose (MTD) of autologous-derived Small Blood Stem Cells in patients undergoing dental implant surgery. Throughout the study, an average of 1 year
See also
  Status Clinical Trial Phase
Completed NCT06139939 - Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique N/A
Not yet recruiting NCT03840681 - Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla N/A
Completed NCT05143242 - Contour Augmentation by Means of Connective Tissue Grafting Versus Guided Bone Regeneration N/A
Not yet recruiting NCT06286605 - RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A N/A
Recruiting NCT03225495 - Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration N/A
Recruiting NCT06295055 - Semi-rigid Shell Barrier System for Alveolar Bone Augmentation (SSBS for ABA) N/A
Not yet recruiting NCT04679766 - Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence N/A
Recruiting NCT06467630 - Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Not yet recruiting NCT06257225 - Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs N/A
Recruiting NCT05890469 - Effect of Implant Surface Material and Topography on Bone Regeneration. N/A

External Links