Guided Bone RegenerationPhase 1NCT04451486
A Phase I Study of SB Cell for the Enhanced Osseointegration of Guided Bone Regeneration in Implant Surgery
A Phase 1 study testing SB cells in people with Guided Bone Regeneration, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration
- What is being tested?
- SB cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2018to 25 Apr 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Da-Yen Wang, PhD, +886-2-2736-1661 ext. 5401, dpw1@tmu.edu.tw
Sheng-Wei Feng, PhD, +886-2-2736-1661 ext. 5401, shengwei@tmu.edu.tw
About this study
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
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.
Read the detailed 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.
- Conditions
- Guided Bone Regeneration
- Being tested
- SB cells
- Keywords
- SB cell、autologous、Osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB cellsDrug
1x10*5 CD61-Lin- cells /0.25mL DPBS
SB cellsDrug
1x10*6 CD61-Lin- cells /0.25mL DPBS
SB cellsDrug
1x10*7 CD61-Lin- cells /0.25mL DPBS
| Study group | Role | What they receive |
|---|---|---|
| Treatment dose 1 | Experimental | 1x10*5 CD61-Lin- cells /0.25mL DPBS Receives: Drug: SB cells |
| Treatment dose 2 | Experimental | 1x10*6 CD61-Lin- cells /0.25mL DPBS Receives: Drug: SB cells |
| Treatment dose 3 | Experimental | 1x10*7 CD61-Lin- cells /0.25mL DPBS Receives: Drug: SB cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Throughout the study, an average of 1 year
Secondary outcomes (1)
The maximum tolerated dose (MTD) of autologous-derived Small Blood Stem Cells in patients undergoing dental implant surgery.
Measured: Throughout the study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Aug 2018
- Primary completion12 Dec 2019
- Study completion25 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Guided Bone RegenerationStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451486
- Sponsor's protocol ID
- N201709009
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schneider R. Prosthetic concerns about atrophic alveolar ridges. Postgrad Dent. 1999;6(2):3-7.
PubMed 11360322de 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.
PubMed 8222609Feng SW, Su YH, Lin YK, Wu YC, Huang YH, Yang FH, Chiang HJ, Yen Y, Wang PD. Small blood stem cells for enhancing early osseointegration formation on dental implants: a human phase I safety study. Stem Cell Res Ther. 2021 Jul 2;12(1):380. doi: 10.1186/s13287-021-02461-z.
PubMed 34215319
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04451486
- Acronym / sponsor ID
- N201709009
- Conditions
- Guided Bone Regeneration
- Keywords
- SB cell、autologous、Osseointegration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 25 Apr 2021 (estimated)
- First posted
- 30 Jun 2020 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment dose 1 | Experimental | Drug: SB cells1x10*5 CD61-Lin- cells /0.25mL DPBS |
| Treatment dose 2 | Experimental | Drug: SB cells1x10*6 CD61-Lin- cells /0.25mL DPBS |
| Treatment dose 3 | Experimental | Drug: SB cells1x10*7 CD61-Lin- cells /0.25mL DPBS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (32 listed)
- Patients who have inadequate organ function described as below:
- History of neoplastic disease and had been treated with chemotherapy;
- Uncontrolled Diabetes Mellitus;
- Dialysis patients;
- Patients with cardiovascular disease;
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 |
|---|---|---|
| SB cells1x10*5 CD61-Lin- cells /0.25mL DPBS | Drug | Treatment dose 1 |
| SB cells1x10*6 CD61-Lin- cells /0.25mL DPBS | Drug | Treatment dose 2 |
| SB cells1x10*7 CD61-Lin- cells /0.25mL DPBS | Drug | Treatment dose 3 |
Primary outcome
Number of participants with adverse events
Time frame: Throughout the study, an average of 1 year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 11360322Schneider R. Prosthetic concerns about atrophic alveolar ridges. Postgrad Dent. 1999;6(2):3-7.
- Background: PubMed 8222609de 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.
- Derived from this study: PubMed 34215319Feng SW, Su YH, Lin YK, Wu YC, Huang YH, Yang FH, Chiang HJ, Yen Y, Wang PD. Small blood stem cells for enhancing early osseointegration formation on dental implants: a human phase I safety study. Stem Cell Res Ther. 2021 Jul 2;12(1):380. doi: 10.1186/s13287-021-02461-z.
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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.
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 SB cells in people with Guided Bone Regeneration, run by Taipei Medical University at 1 site in Taiwan.
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 8 inclusion and 32 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 30 Jun 2020. 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 Taiwan. 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. 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?
Contact Da-Yen Wang, PhD (+886-2-2736-1661 ext. 5401, dpw1@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Throughout the study, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04451486, which also lists 3 linked publications.
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 30 Jun 2020.