A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union
NCT ID: NCT03325504
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
46 participants
INTERVENTIONAL
2017-09-05
2023-12-15
Brief Summary
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Detailed Description
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Non-unions, or pseudarthrosis, may occur in 5% to 20% of long-bone fractures that fail to heal properly after more than 6 months, with morbidity, prolonged hospitalization, and increased expenses. The most commonly accepted standard augmentation to procure fracture and non-union healing consists of autologous bone grafting, obtained from the same patient in a different surgical site and transplanted to the reconstruction site. However, autologous bone grafting has some drawbacks (such as persistent pain, scar, late recovery, limited amount of bone, etc) and a limited regeneration efficacy (success rate of about 74%) and high societal cost. Culture-expanded autologous MSCs combined with biphasic calcium phosphate (BCP) biomaterial granules have been claimed as a solid regenerative medicine alternative to autologous bone grafting in non-unions, although current data are limited. In this context, the ORTHOUNION initiative focuses on the opportunity to test the hypothesis of superiority of MSC, the investigational ATMP, versus the currently accepted standard therapy, iliac crest bone autograft to biologically augment surgical treatment of long-bone non-unions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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hBM-MSCs-Low Dose
Autologous Cultured Mesenchymal Stem Cells +Biomaterial (Low Dose): 100x106 cells
Cultured Mesenchymal Stem Cells
Cultured Mesenchymal Stem Cells obtained from expanded bone marrow
hBM-MSCs-High Dose
Autologous Cultured Mesenchymal Stem Cells+Biomaterial (High Dose): 200x106 cells
Cultured Mesenchymal Stem Cells
Cultured Mesenchymal Stem Cells obtained from expanded bone marrow
Autologous iliac crest graft
Autologous Iliac Crest Grafting
Autologous iliac crest graft
Autologous iliac crest grafting
Interventions
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Cultured Mesenchymal Stem Cells
Cultured Mesenchymal Stem Cells obtained from expanded bone marrow
Autologous iliac crest graft
Autologous iliac crest grafting
Eligibility Criteria
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Inclusion Criteria
2. Traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union.
3. Able to understand, accept and sign informed consent
4. Medical health coverage
5. Able to understand and accept the study constraints
Exclusion Criteria
2. Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)
3. Unrecovered vascular or neural injury
4. Other fractures causing interference with weight bearing
5. Visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.)
6. Active infection of any location and aetiology
7. Surgical contraindication of any cause
8. Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
9. Malignant tumour (past history or concurrent disease)(except carcinoma in situ or basalioma in remission)
10. History of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection
11. Insulin dependent diabetes
12. Any evidence (confirmed by PCR) of active infection with HIV, Hepatitis B or Hepatitis C infection
13. Any evidence of Syphilis
14. Known allergies to products involved in the production process of MSC
15. Corticoid or immunosuppressive therapy more than one week in the three months prior to study inclusion
16. Autoimmune inflammatory disease
17. Current treatment by biphosphonates not stopped three months prior to study inclusion
18. Impossibility to meet at the appointments for the follow up
19. Participation in another therapeutic trial in the previous 3 months
20. Second non-union in case of bilateral or multiple non-unions (only one non-union per patient will be included in the trial)
18 Years
99 Years
ALL
No
Sponsors
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Universidad Autonoma de Madrid
OTHER
Responsible Party
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Prof Enrique Gomez-Barrena
Full Professor and Chair of orthopaedic surgery
Principal Investigators
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Enrique Gomez-Barrena, Prof
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma de Madrid
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Department of Orthopaedic Surgery, Hospital Henri Mondor
Créteil, , France
Department of Orthopaedic Surgery, CHU Nantes
Nantes, , France
Department of Orthopaedic Surgery Toulouse University Hospital
Toulouse, , France
Department of Orthopaedic Surgery, CHU Tours
Tours, , France
Universitätsklinikum Frankfurt, Department of Trauma, Hand and Reconstructive Surgery
Frankfurt, , Germany
Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie
Freiburg im Breisgau, , Germany
Universitätsklinikum München
Munich, , Germany
Department of Orthopaedic Trauma, University of Ulm
Ulm, , Germany
Istituto Ortopedico Rizzoli, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa
Bologna, , Italy
Arienda Spedali Civili di Brescia II Ortopedia e Traumatologia
Brescia, , Italy
Istituto Ortopedico Galeazzi, Chirugia dell´Anca l
Milan, , Italy
Hospital U. Puerta de Hierro-Majadahonda, Servicio de Cirugía Ortopédica y Traumatología
Majadahonda, Madrid, Spain
Hospital Clínica San Carlos, Servicio de Cirugía Ortopédica y Traumatología
Madrid, , Spain
Hospital U. 12 de Octubre, Servicio de Cirugía Ortopédica y Traumatología
Madrid, , Spain
Hospital U. Gregorio Marañon, Servicio de Cirugía Ortopédica y Traumatología
Madrid, , Spain
Hospital U. La Princesa, Servicio de CirugíaOrtopédica y Traumatología
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Madrid, , Spain
Countries
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References
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Gomez-Barrena E, Padilla-Eguiluz NG, Avendano-Sola C, Payares-Herrera C, Velasco-Iglesias A, Torres F, Rosset P, Gebhard F, Baldini N, Rubio-Suarez JC, Garcia-Rey E, Cordero-Ampuero J, Vaquero-Martin J, Chana F, Marco F, Garcia-Coiradas J, Caba-Dessoux P, de la Cuadra P, Hernigou P, Flouzat-Lachaniette CH, Gouin F, Mainard D, Laffosse JM, Kalbitz M, Marzi I, Sudkamp N, Stockle U, Ciapetti G, Donati DM, Zagra L, Pazzaglia U, Zarattini G, Capanna R, Catani F. A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol. Stem Cells Int. 2018 Feb 22;2018:6025918. doi: 10.1155/2018/6025918. eCollection 2018.
Related Links
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Webpage of the Orthounion Study
Other Identifiers
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2015-000431-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EUCTR2015-000431-32-ES
Identifier Type: REGISTRY
Identifier Source: secondary_id
ORTHOUNION
Identifier Type: -
Identifier Source: org_study_id