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Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting (Maxibone)

Primary Purpose

Alveolar Bone Atrophy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Advanced medicinal Therapy (MSC combined with biomaterial)
Autologous bone graft
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Atrophy focused on measuring Maxilla, mandible,, MSC, RCT, Bone regeneration, Multicenter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width.

Exclusion Criteria:

  • General contraindications for dental and/or surgical treatments
  • Contraindications for both bone marrow harvesting and bone grafts
  • History of any malignant diseases
  • Concurrent or previous radiotherapy of head and neck region
  • History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
  • Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient's history and concurrent HbA1c levels (HbA1c > 53 mmol/mol).
  • Inflammatory and autoimmune disease of the oral cavity.
  • Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.

Sites / Locations

  • Syddansk Universitet SDU (University Hospital of Southern Denmark)Recruiting
  • Assistance Publique - Hôpitaux De ParisRecruiting
  • CHU Nantes, Centre de Soins DentairesRecruiting
  • University of Bergen, Institute of Clonical DentistryRecruiting
  • Universidad Complutense De MadridRecruiting
  • Universitat Internacional De CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Test

Arm Description

The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.

Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate

Outcomes

Primary Outcome Measures

Change in bone width
Changes in linear measurements of bone width measured by CBCT.Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement

Secondary Outcome Measures

Pain postoperatively in the two different treatments
Assessed by VAS scale, the scale goes from 0 to 100, 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Radiological examination of bone volume
To evaluate the formation of the new bone by assessing if it is possible to insert an implant in the reconstructed area 5 months after the grafting procedure. This decision will be made based on radiological examination of bone volume by means of 3D CBCT images captured immediately prior to implant placement, 5-6 months after the regenerative surgery.

Full Information

First Posted
February 25, 2020
Last Updated
March 10, 2020
Sponsor
University of Bergen
Collaborators
Université de Nantes, University of Ulm, Universidad Complutense de Madrid, University of Aarhus, Universitat Internacional de Catalunya, Assistance Publique - Hôpitaux de Paris, European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04297813
Brief Title
Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
Acronym
Maxibone
Official Title
Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
Collaborators
Université de Nantes, University of Ulm, Universidad Complutense de Madrid, University of Aarhus, Universitat Internacional de Catalunya, Assistance Publique - Hôpitaux de Paris, European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.
Detailed Description
A phase III multi center clinical trial, randomized and controlled.The study subject is lacking one or more sheet behind the canine in the upper or lower jaw, and the alveolar ridge is too narrow to place a dental implant. The test objects will have augmentation using autologous mesenchymal stromal cells and a biomaterial, biphasic Calcium Phosphate. The control is the traditional bone block from the ramus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Atrophy
Keywords
Maxilla, mandible,, MSC, RCT, Bone regeneration, Multicenter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with advanced therapy medicinal product
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.
Arm Title
Test
Arm Type
Experimental
Arm Description
Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate
Intervention Type
Combination Product
Intervention Name(s)
Advanced medicinal Therapy (MSC combined with biomaterial)
Intervention Description
Augmentation of alveolar ridge with MSC and biomaterial
Intervention Type
Procedure
Intervention Name(s)
Autologous bone graft
Intervention Description
Augmentation of the alveolar ridge with bone graft
Primary Outcome Measure Information:
Title
Change in bone width
Description
Changes in linear measurements of bone width measured by CBCT.Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement
Time Frame
0-5 months
Secondary Outcome Measure Information:
Title
Pain postoperatively in the two different treatments
Description
Assessed by VAS scale, the scale goes from 0 to 100, 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time Frame
21 months
Title
Radiological examination of bone volume
Description
To evaluate the formation of the new bone by assessing if it is possible to insert an implant in the reconstructed area 5 months after the grafting procedure. This decision will be made based on radiological examination of bone volume by means of 3D CBCT images captured immediately prior to implant placement, 5-6 months after the regenerative surgery.
Time Frame
21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width. Exclusion Criteria: General contraindications for dental and/or surgical treatments Contraindications for both bone marrow harvesting and bone grafts History of any malignant diseases Concurrent or previous radiotherapy of head and neck region History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection) Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient's history and concurrent HbA1c levels (HbA1c > 53 mmol/mol). Inflammatory and autoimmune disease of the oral cavity. Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamal Mustafa, Professor
Phone
+47 98497607
Email
kamal.mustafa@uib.no
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilie Gjerde, DDS
Phone
+47 55 58 64 41
Email
cecilie.gjerde@uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Sanz, Professor
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Else Marie Pinholt, Professor
Organizational Affiliation
Syddansk Universitet SDU (University Hospital of Southern Denmark)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Federico Hernandez-Alfaroo, Professor
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain Hoornaert, DDS
Organizational Affiliation
CHU Nantes, Centre de Soins Dentaires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederik Gaultier, PhD/DDS
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syddansk Universitet SDU (University Hospital of Southern Denmark)
City
Odense
ZIP/Postal Code
5230
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Thesbjerg, DDS
Email
kristian.thesbjerg@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Else Pinholt
Phone
+45 40 16 13 58
Email
empinholt@health.sdu.dk
Facility Name
Assistance Publique - Hôpitaux De Paris
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederik Gaultier, PhD/DDS
Phone
+33 1 45 17 84 05
Email
frederick.gaultier@parisdescartes.fr
First Name & Middle Initial & Last Name & Degree
Bruno Gogly, DDS
Phone
+33 1 49 81 31 33
Email
bruno.gogly@aphp.fr
Facility Name
CHU Nantes, Centre de Soins Dentaires
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Hoornaert, DDS
Phone
+33 2 40 73 88 66
Email
alain.hoornaert@univ-nantes.fr
First Name & Middle Initial & Last Name & Degree
Claire Fourcade, DDS
Email
clairefourcade@aol.com
Facility Name
University of Bergen, Institute of Clonical Dentistry
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5009
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilie Gjerde, DDS
Phone
+4755586000
Email
cecilie.gjerde@uib.no
First Name & Middle Initial & Last Name & Degree
Kamal Mustafa, Prof
Phone
+4755586000
Email
kamal.mustafa@uib.no
Facility Name
Universidad Complutense De Madrid
City
Madrid
State/Province
Calle Fernando De Castro Rodriguez,
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano Sanz, Prof
Phone
+34 913 942 010
Email
marsan@ucm.es
First Name & Middle Initial & Last Name & Degree
Alberto Ortiz-Vigón, PhD/DDS
Phone
+34 9 44 15 89 02
Email
alberto@ortizvigon.com
Facility Name
Universitat Internacional De Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Caballe Serrano, DDS
Phone
+34 6 96 54 03 64
Email
jordicase@uic.es
First Name & Middle Initial & Last Name & Degree
Maria Giralt, DDS
Phone
+34 6 96 54 03 64
Email
mariagiralth@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participants data for all primary and secondary outcome measures will be made available
IPD Sharing Time Frame
Data will be available after study completion
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement
IPD Sharing URL
http://maxibone.eu
Citations:
PubMed Identifier
30092840
Citation
Gjerde C, Mustafa K, Hellem S, Rojewski M, Gjengedal H, Yassin MA, Feng X, Skaale S, Berge T, Rosen A, Shi XQ, Ahmed AB, Gjertsen BT, Schrezenmeier H, Layrolle P. Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial. Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9.
Results Reference
background
PubMed Identifier
30926359
Citation
Rojewski MT, Lotfi R, Gjerde C, Mustafa K, Veronesi E, Ahmed AB, Wiesneth M, Korper S, Sensebe L, Layrolle P, Hellem S, Schrezenmeier H. Translation of a standardized manufacturing protocol for mesenchymal stromal cells: A systematic comparison of validation and manufacturing data. Cytotherapy. 2019 Apr;21(4):468-482. doi: 10.1016/j.jcyt.2019.03.001. Epub 2019 Mar 27.
Results Reference
background
Links:
URL
http://maxibone.eu
Description
Webpage for the clinical trial

Learn more about this trial

Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting

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