Alveolar Bone AtrophyPhase 3MaxiboneNCT04297813
Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
A Phase 3 study testing Advanced medicinal Therapy (MSC combined with biomaterial) and Autologous bone graft in people with Alveolar Bone Atrophy, run by University of Bergen at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Atrophy
- What is being tested?
- Advanced medicinal Therapy (MSC combined with biomaterial) and Autologous bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 12 Mar 2020to 31 Jul 2024
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France2 sites
Assistance Publique - Hôpitaux De Paris
Créteil, 94010
CHU Nantes, Centre de Soins Dentaires
Nantes, 44000
Spain2 sites
Universitat Internacional De Catalunya
Barcelona, 08195
Universidad Complutense De Madrid
Madrid, Calle Fernando de Castro Rodriguez,, 28040
Denmark1 site
Syddansk Universitet SDU (University Hospital of Southern Denmark)
Odense, 5230
Norway1 site
University of Bergen, Institute of Clonical Dentistry
Bergen, Hordaland, 5009
About this study
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
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.
Read the 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.
- Conditions
- Alveolar Bone Atrophy
- Being tested
- Advanced medicinal Therapy (MSC combined with biomaterial), Autologous bone graft
- Keywords
- Maxilla, mandible,, MSC, RCT, Bone regeneration, Multicenter
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced medicinal Therapy (MSC combined with biomaterial)Combination product
Augmentation of alveolar ridge with MSC and biomaterial
Autologous bone graftProcedure or surgery
Augmentation of the alveolar ridge with bone graft
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge. Receives: Procedure: Autologous bone graft |
| Test | Experimental | Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate Receives: Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-5 months
Secondary outcomes (2)
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."
Measured: 21 months
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.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start12 Mar 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2024
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 Alveolar Bone AtrophyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with advanced therapy medicinal product
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz, Professor, Principal investigator, Universidad Complutense de MadridElse Marie Pinholt, Professor, Principal investigator, Syddansk Universitet SDU (University Hospital of Southern Denmark)Federico Hernandez-Alfaroo, Professor, Principal investigator, Universitat Internacional de CatalunyaAlain Hoornaert, DDS, Principal investigator, CHU Nantes, Centre de Soins DentairesFrederik Gaultier, PhD/DDS, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297813
- Sponsor's protocol ID
- 2018-001227-39
- Other IDs
- 2018-001227-39, 2018
- Acronym
- Maxibone
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participants data for all primary and secondary outcome measures will be made available
Publications
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.
PubMed 30092840Rojewski 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.
PubMed 30926359Sanz 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.
PubMed 40844304
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04297813
- Acronym / sponsor ID
- Maxibone / 2018-001227-39
- Conditions
- Alveolar Bone Atrophy
- Keywords
- Maxilla, mandible,, MSC, RCT, Bone regeneration, Multicenter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- 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
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with advanced therapy medicinal product
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Autologous bone graftThe gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge. |
| Test | Experimental | Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Advanced medicinal Therapy (MSC combined with biomaterial)Augmentation of alveolar ridge with MSC and biomaterial | Combination product | Test |
| Autologous bone graftAugmentation of the alveolar ridge with bone graft | Procedure or surgery | Control |
Primary outcome
Change in bone width
Time frame: 0-5 months
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
2 secondary outcomes
Pain postoperatively in the two different treatments
Time frame: 21 months
Radiological examination of bone volume
Time frame: 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Background: PubMed 30092840Gjerde 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.
- Background: PubMed 30926359Rojewski 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.
- Derived from this study: PubMed 40844304Sanz 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.
- Webpage for the clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participants data for all primary and secondary outcome measures will be made available
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Enrolling by invitation
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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.
Mariano Sanz, Professor principal investigator
Universidad Complutense de Madrid
Else Marie Pinholt, Professor principal investigator
Syddansk Universitet SDU (University Hospital of Southern Denmark)
Federico Hernandez-Alfaroo, Professor principal investigator
Universitat Internacional de Catalunya
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Advanced medicinal Therapy (MSC combined with biomaterial) and Autologous bone graft in people with Alveolar Bone Atrophy, run by University of Bergen at 6 sites in 4 countries.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Spain, Denmark, Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone width (time frame: 0-5 months). 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 NCT04297813, 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 29 Jun 2025.