Bone Regeneration Using Mesenchymal Stromal Cells and Biocompatible Scaffolds: A Concise Review of the Current Clinical Trials

Federica Re; Elisa Borsani; Rita Rezzani; Luciana Sartore; Domenico Russo

doi:10.3390/gels9050389

Bone Regeneration Using Mesenchymal Stromal Cells and Biocompatible Scaffolds: A Concise Review of the Current Clinical Trials

Gels. 2023 May 8;9(5):389. doi: 10.3390/gels9050389.

Authors

Federica Re^{1

2}, Elisa Borsani^{3

4}, Rita Rezzani^{3

4}, Luciana Sartore⁵, Domenico Russo¹

Affiliations

¹ Unit of Blood Diseases and Cell Therapies, Department of Clinical and Experimental Sciences, University of Brescia, "ASST-Spedali Civili" Hospital of Brescia, 25123 Brescia, Italy.
² Centro di Ricerca Emato-Oncologica AIL (CREA), ASST Spedali Civili, 25123 Brescia, Italy.
³ Division of Anatomy and Physiopathology, Department of Clinical and Experimental Sciences, University of Brescia, 25123 Brescia, Italy.
⁴ Interdepartmental University Center of Research "Adaption and Regeneration of Tissues and Organs (ARTO)", University of Brescia, 25123 Brescia, Italy.
⁵ Department of Mechanical and Industrial Engineering, Materials Science and Technology Laboratory, University of Brescia, 25123 Brescia, Italy.

Abstract

Bone regenerative medicine is a clinical approach combining live osteoblast progenitors, such as mesenchymal stromal cells (MSCs), with a biocompatible scaffold that can integrate into host bone tissue and restore its structural integrity. Over the last few years, many tissue engineering strategies have been developed and thoroughly investigated; however, limited approaches have been translated to clinical application. Consequently, the development and clinical validation of regenerative approaches remain a centerpiece of investigational efforts towards the clinical translation of advanced bioengineered scaffolds. The aim of this review was to identify the latest clinical trials related to the use of scaffolds with or without MSCs to regenerate bone defects. A revision of the literature was performed in PubMed, Embase, and Clinicaltrials.gov from 2018 up to 2023. Nine clinical trials were analyzed according to the inclusion criteria: six presented in the literature and three reported in Clinicaltrials.gov. Data were extracted covering background trial information. Six of the clinical trials added cells to scaffolds, while three used scaffolds alone. The majority of scaffolds were composed of calcium phosphate ceramic alone, such as β-tricalcium phosphate (TCP) (two clinical trials), biphasic calcium phosphate bioceramic granules (three clinical trials), and anorganic bovine bone (two clinical trials), while bone marrow was the primary source of the MSCs (five clinical trials). The MSC expansion was performed in GMP facilities, using human platelet lysate (PL) as a supplement without osteogenic factors. Only one trial reported minor adverse events. Overall, these findings highlight the importance and efficacy of cell-scaffold constructs in regenerative medicine under different conditions. Despite the encouraging clinical results obtained, further studies are needed to assess their clinical efficacy in treating bone diseases to optimize their application.

Keywords: bone regeneration; clinical trials; human platelet lysate; hydrogels; mesenchymal stromal cells; scaffolds; tissue regeneration.

Publication types

Review

Grants and funding

This research received no external funding.