Clinical trial NCT04297813: Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alveolar Bone Atrophy
Keywords: Maxilla
mandible,
MSC
RCT
Bone regeneration
Multicenter
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Université de Nantes
name: University of Ulm
name: Universidad Complutense de Madrid
name: University of Aarhus
name: Universitat Internacional de Catalunya
name: Assistance Publique - Hôpitaux de Paris
name: European Commission
First posted: 2020-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with advanced therapy medicinal product
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in bone width
timeFrame: 0-5 months
Secondary outcomes:
measure: Pain postoperatively in the two different treatments
timeFrame: 21 months
measure: Radiological examination of bone volume
timeFrame: 21 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Syddansk Universitet SDU (University Hospital of Southern Denmark)
city: Créteil
country: France
facility: Assistance Publique - Hôpitaux De Paris
city: Nantes
country: France
facility: CHU Nantes, Centre de Soins Dentaires
city: Bergen
country: Norway
facility: University of Bergen, Institute of Clonical Dentistry
state: Hordaland
city: Madrid
country: Spain
facility: Universidad Complutense De Madrid
state: Calle Fernando De Castro Rodriguez,
city: Barcelona
country: Spain
facility: Universitat Internacional De Catalunya
Study officials:
affiliation: Universidad Complutense de Madrid
name: Mariano Sanz, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Syddansk Universitet SDU (University Hospital of Southern Denmark)
name: Else Marie Pinholt, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Internacional de Catalunya
name: Federico Hernandez-Alfaroo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nantes, Centre de Soins Dentaires
name: Alain Hoornaert, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederik Gaultier, PhD/DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.