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

Alveolar Bone Atrophy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297813
• Other study ID #: 2018-001227-39
• Secondary ID: 2018-001227-39
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2020
• Est. completion date: September 2024

Study information

• Verified date: March 2020
• Source: University of Bergen
• Contact: Kamal Mustafa, Professor
• Phone: +47 98497607
• Email: kamal.mustafa[@]uib.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Atrophy
• Alveolar Bone Loss
• Atrophy

Intervention

Combination Product:
• Advanced medicinal Therapy (MSC combined with biomaterial)
Augmentation of alveolar ridge with MSC and biomaterial

Procedure:
• Autologous bone graft
Augmentation of the alveolar ridge with bone graft

Locations

Country	Name	City	State
Denmark	Syddansk Universitet SDU (University Hospital of Southern Denmark)	Odense
France	Assistance Publique - Hôpitaux De Paris	Créteil
France	CHU Nantes, Centre de Soins Dentaires	Nantes
Norway	University of Bergen, Institute of Clonical Dentistry	Bergen	Hordaland
Spain	Universitat Internacional De Catalunya	Barcelona
Spain	Universidad Complutense De Madrid	Madrid	Calle Fernando De Castro Rodriguez,

Sponsors (8)

Lead Sponsor	Collaborator
University of Bergen	Assistance Publique - Hôpitaux de Paris, European Commission, Universidad Complutense de Madrid, Universitat Internacional de Catalunya, Université de Nantes, University of Aarhus, University of Ulm

Countries where clinical trial is conducted

Denmark,  France,  Norway,  Spain, 

References & Publications (2)

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. — View Citation

Rojewski MT, Lotfi R, Gjerde C, Mustafa K, Veronesi E, Ahmed AB, Wiesneth M, Körper S, Sensebé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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."	21 months
Secondary	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.	21 months

External Links

•   Webpage for the clinical trial