NCT04451486

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2021

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

June 15, 2020

Last Update Submit

June 28, 2020

Conditions

Guided Bone Regeneration

Keywords

SB cell、autologous、Osseointegration

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    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.

    Throughout the study, an average of 1 year

Study Arms (3)

Treatment dose 1

EXPERIMENTAL

1x10\*5 CD61-Lin- cells /0.25mL DPBS

Drug: SB cells

Treatment dose 2

EXPERIMENTAL

1x10\*6 CD61-Lin- cells /0.25mL DPBS

Drug: SB cells

Treatment dose 3

EXPERIMENTAL

1x10\*7 CD61-Lin- cells /0.25mL DPBS

Drug: SB cells

Interventions

SB cellsDRUG

1x10\*5 CD61-Lin- cells /0.25mL DPBS

Treatment dose 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Related Publications (3)

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

    PMID: 11360322BACKGROUND

  • 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: 8222609BACKGROUND

  • Feng 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.

    PMID: 34215319DERIVED

Central Study Contacts

Da-Yen Wang, PhD

CONTACT

+886-2-2736-1661dpw1@tmu.edu.tw

Sheng-Wei Feng, PhD

CONTACT

+886-2-2736-1661shengwei@tmu.edu.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 30, 2020

Study Start

August 10, 2018

Primary Completion

December 12, 2019

Study Completion

April 25, 2021

Last Updated

June 30, 2020

Record last verified: 2020-06

Locations

TW(1)