A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Taipei Medical University
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Updated on 19 February 2024
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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 group1105 CD61-Lin- cells /0.25mL DPBS Treatment dose 2 group1106 CD61-Lin- cells /0.25mL DPBS Treatment dose 3 group110*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.

Details
Condition Guided Bone Regeneration
Age 20years - 100years
Treatment SB cells
Clinical Study IdentifierNCT04451486
SponsorTaipei Medical University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects 20 years old and over
Sign of informed consent form
Patients with one missing tooth with D2, D3 bone density
Gums environment defined as alveolar bone height of 10 mm and above, bone width 8 mm and above
Have only one missing maxillary or mandibular posterior tooth (No. 4, 5, 6 or 7) who require a GBR prior to a dental implant
Bone defect(s) must be present with at least two walls missing
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
Subject is able to understand and comply with protocol requirements, instructions and protocol stated restrictions

Exclusion Criteria

Patients who have inadequate organ function described as below
ANC < 1.5 x 109/L
Platelets < 100 x 109/L
Hb < 9 g/dL
Serum bilirubin < 1.5 x the upper limit of normal (ULN)
Aspartate aminotransferase (AST [SGOT]) < 2.5 the ULN
Alanine aminotransferase (ALT [SGPT]) > 2.5 the ULN
Serum creatinine > 1.5 mg/dL or a measured creatinine clearance < 60 mL/min
History of neoplastic disease and had been treated with chemotherapy
Uncontrolled Diabetes Mellitus
Dialysis patients
Patients with cardiovascular disease
Osteoporosis patients and patients taking bisphosphonates
History of radiation therapy to the head and neck
Patients with temporomandibular disorder
Pregnant or nursing women
Presence of conditions requiring chronic routine prophylactic use of antibiotics (history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
Medical conditions requiring prolonged use of steroids
Physical handicaps that would interfere with the ability to perform adequate oral hygiene
Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0
Alcoholism or drug abuse
Patients infected with HIV
Current smokers
Local inflammation, including untreated periodontitis
Mucosal diseases such as erosive lichen planus
History of local radiation therapy
Presence of osseous lesions
Unhealed extraction sites
Persistent intraoral infection
Patients with inadequate oral hygiene or unmotivated for adequate home care
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
Patient with a pathology present near the site of dental implantation
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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