A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union

PHASE3CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

September 5, 2017

Primary Completion Date

October 17, 2022

Study Completion Date

December 15, 2023

Conditions
Non Union Fracture
Interventions
BIOLOGICAL

Cultured Mesenchymal Stem Cells

Cultured Mesenchymal Stem Cells obtained from expanded bone marrow

PROCEDURE

Autologous iliac crest graft

Autologous iliac crest grafting

Trial Locations (19)

37044

Department of Orthopaedic Surgery, CHU Tours, Tours

40136

Istituto Ortopedico Rizzoli, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa, Bologna

8907581

Department of Orthopaedic Trauma, University of Ulm, Ulm

Unknown

CHU Clermont-Ferrand, Clermont-Ferrand

Department of Orthopaedic Surgery, Hospital Henri Mondor, Créteil

Department of Orthopaedic Surgery, CHU Nantes, Nantes

Department of Orthopaedic Surgery Toulouse University Hospital, Toulouse

Universitätsklinikum Frankfurt, Department of Trauma, Hand and Reconstructive Surgery, Frankfurt

Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie, Freiburg im Breisgau

Universitätsklinikum München, Munich

Arienda Spedali Civili di Brescia II Ortopedia e Traumatologia, Brescia

Istituto Ortopedico Galeazzi, Chirugia dell´Anca l, Milan

Hospital U. Puerta de Hierro-Majadahonda, Servicio de Cirugía Ortopédica y Traumatología, Majadahonda

Hospital Clínica San Carlos, Servicio de Cirugía Ortopédica y Traumatología, Madrid

Hospital U. 12 de Octubre, Servicio de Cirugía Ortopédica y Traumatología, Madrid

Hospital U. Gregorio Marañon, Servicio de Cirugía Ortopédica y Traumatología, Madrid

Hospital U. La Princesa, Servicio de CirugíaOrtopédica y Traumatología, Madrid

Hospital Universitario Ramón y Cajal, Madrid

"Servicio de Cirugía Ortopédica y Traumatología A, Hospital La Paz", Madrid

All Listed Sponsors
lead

Universidad Autonoma de Madrid

OTHER

NCT03325504 - A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union | Biotech Hunter | Biotech Hunter