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Feasibility and safety of treating non-unions in tibia, femur and humerus with autologous, expanded, bone marrow-derived mesenchymal stromal cells associated with biphasic calcium phosphate biomaterials in a multicentric, non-comparative trial
- Source :
- Biomaterials, Biomaterials, Elsevier, 2018, epub ahead of print. ⟨10.1016/j.biomaterials.2018.03.033⟩, Biblos-e Archivo. Repositorio Institucional de la UAM, instname, Biomaterials, 2018, epub ahead of print. ⟨10.1016/j.biomaterials.2018.03.033⟩
- Publication Year :
- 2017
-
Abstract
- Background: ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis. Methods: Twenty-eight patients with femur, tibia or humerus diaphyseal or metaphyso-diaphyseal non-unions were recruited and surgically treated in France, Germany, Italy and Spain with 100 or 200 million BM-hMSC/mL associated with 5–10 cc of bioceramic granules. Patients were followed up during one year. The investigational advanced therapy medicinal product (ATMP) was expanded under the same protocol in all four countries, and approved by each National Competent Authority. Findings: With safety as primary end-point, no severe adverse event was reported as related to the BM-hMSC. With feasibility as secondary end-point, the participating production centres manufactured the BM-hMSC as planned. The ATMP combined to the bioceramic was surgically delivered to the non-unions, and 26/28 treated patients were found radiologically healed at one year (3 out of 4 cortices with bone bridging). Interpretation: Safety and feasibility were clinically proven for surgical implantation of expanded autologous BM-hMSC with bioceramic. Funding: EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876).<br />The research leading to these results has received funding from the European Research Council under the European Union's Seventh Framework Programme (FP7/FP7-HEALTH-2009); REBORNE Project (GA: 241876)
- Subjects :
- Calcium Phosphates
Biocompatible Materials
02 engineering and technology
Bone tissue engineering
Fractures, Bone
Femur
media_common
[SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system
0303 health sciences
[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology
021001 nanoscience & nanotechnology
3. Good health
Clinical trial
medicine.anatomical_structure
[SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system
Mechanics of Materials
[SDV.IB]Life Sciences [q-bio]/Bioengineering
0210 nano-technology
medicine.medical_specialty
Bioceramic
Medicina
Biophysics
Ceramics and Composite
Bioengineering
Mesenchymal Stem Cell Transplantation
Non-union
Transplantation, Autologous
Non union
Expanded autologous BM-hMSC
Biomaterials
03 medical and health sciences
medicine
media_common.cataloged_instance
Humans
Humerus
Tibia
European union
[SDV.IB.BIO]Life Sciences [q-bio]/Bioengineering/Biomaterials
030304 developmental biology
Cell Proliferation
[SDV.IB] Life Sciences [q-bio]/Bioengineering
business.industry
Mesenchymal stem cell
Mesenchymal Stem Cells
ATMP
Biomaterial
Surgery
[SDV.IB.BIO] Life Sciences [q-bio]/Bioengineering/Biomaterials
Biophysic
Fractures, Ununited
Ceramics and Composites
Feasibility Studies
Bone marrow
business
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Subjects
Details
- ISSN :
- 18785905 and 01429612
- Volume :
- 196
- Database :
- OpenAIRE
- Journal :
- Biomaterials
- Accession number :
- edsair.doi.dedup.....88fe06d1cd7617668e748b70602d628f