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

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.

Timeline

Start

2020-03-12

Primary completion

2023-07-31

Completion

2024-07-31

Publications

• Background 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.
• Background 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.
• 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.

Drugs

Indications