NCT04297813

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2020

Typical duration for phase_3

Geographic Reach
4 countries

6 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

March 12, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

June 29, 2025

Status Verified

March 1, 2020

Enrollment Period

3.4 years

First QC Date

February 25, 2020

Last Update Submit

June 25, 2025

Conditions

Alveolar Bone Atrophy

Keywords

Maxillamandible,MSCRCTBone regenerationMulticenter

Outcome Measures

Primary Outcomes (1)

  • 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

    0-5 months

Secondary Outcomes (2)

  • Pain postoperatively in the two different treatments

    21 months

  • Radiological examination of bone volume

    21 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Autologous bone graft

Test

EXPERIMENTAL

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

Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)

Interventions

Advanced medicinal Therapy (MSC combined with biomaterial)COMBINATION_PRODUCT

Augmentation of alveolar ridge with MSC and biomaterial

Test
Autologous bone graftPROCEDURE

Augmentation of the alveolar ridge with bone graft

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Syddansk Universitet SDU (University Hospital of Southern Denmark)

Odense, 5230, Denmark

Location

Assistance Publique - Hôpitaux De Paris

Créteil, 94010, France

Location

CHU Nantes, Centre de Soins Dentaires

Nantes, 44000, France

Location

University of Bergen, Institute of Clonical Dentistry

Bergen, Hordaland, 5009, Norway

Location

Universidad Complutense De Madrid

Madrid, Calle Fernando de Castro Rodriguez,, 28040, Spain

Location

Universitat Internacional De Catalunya

Barcelona, 08195, Spain

Location

Related Publications (3)

  • 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.

    PMID: 30092840BACKGROUND

  • 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.

    PMID: 30926359BACKGROUND

  • Sanz M, Gjerde C, Gjertsen BT, Ortiz-Vigon A, Sanchez N, Hoornaert A, Caballe-Serrano J, Giralt-Hernando M, Gaultier F, Reinald N, Pinholt EM, Rojewski M, Rouard H, Chevallier N, Mohamed-Ahmed S, Shi X, Shi TJ, Schrezenmeier H, Layrolle P, Mustafa K. Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial. Clin Oral Implants Res. 2025 Nov;36(11):1498-1514. doi: 10.1111/clr.70025. Epub 2025 Aug 22.

    PMID: 40844304DERIVED

Related Links

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Biocompatible Materials

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mariano Sanz, Professor

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

  • Else Marie Pinholt, Professor

    Syddansk Universitet SDU (University Hospital of Southern Denmark)

    PRINCIPAL INVESTIGATOR

  • Federico Hernandez-Alfaroo, Professor

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

  • Alain Hoornaert, DDS

    CHU Nantes, Centre de Soins Dentaires

    PRINCIPAL INVESTIGATOR

  • Frederik Gaultier, PhD/DDS

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with advanced therapy medicinal product
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 6, 2020

Study Start

March 12, 2020

Primary Completion

July 31, 2023

Study Completion

July 31, 2024

Last Updated

June 29, 2025

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

De-identified individual participants data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available after study completion
Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement
More information

Locations

DK(1)ES(2)NO(1)FR(2)