The ORTHOUNION project has been divided into 7 work packages, addressing: the orthopaedic clinical trial; the cell production; the trial management and regulation; the economical and societal issues; ethics; and the coordination and project management with dissemination and exploitation strategies .
WP1: Clinical trial.
This is the central WP of the project, where the planned clinical research will be structured. Involved partners are those clinical partners from the previous ORTHO-1 trial project that developed the feasibility, safety and early efficacy phase I/IIa preliminary trial. These clinical partners have been capable of structuring a clinical network based on third parties approach to expand the capability of recruiting and treating patients in a large number of major clinical centres in Spain, France, Germany and, Italy and now will act as national coordinators of their respective national networks.
WP2: Cell production.
This is the complementary WP in the project to produce and release the Investigational Medicinal Product (IMP) and to control the quality of comparators (bone marrow of the autograft donor area and bone marrow concentrate). It is integrated by the 5 Good Manufacturing Practice (GMP) facilities that previously standardized and produced the cell product under investigation implanted in the REBORNE trials patients.
WP3: Trial management and regulation.
This WP support the clinical trial development according to the defined calendar and the GCP rules to ensure quality of data. The integrated partners will direct their efforts to ensure reliability of the data derived from the clinical trials, with the partnership of ECRIN-Eric. This package will include the necessary clinical trial support and management activities from sponsorship to data management, monitoring and pharmacovigilance.
WP4: Economics and societal issues.
This work package will cover country specific and global analysis of economic aspects through cost-effectiveness and cost-utility approaches. These would help to define the opportunities of industrial development and would lead to a proposal of a business plan, by production escalation to an industrial model.
WP5: Innovation strategies.
This work package aims at exploring novel assay, biomarkers or production processes to improve the outcome of MSC therapy for bone regeneration, taking advantage of the ongoing clinical trial.
This WP is related with all the working packages and is necessary to set out the ethical requirements that the project must comply with.
WP7: Coordination, management, dissemination and exploitation.
This WP is necessary to support the timing and delivery of results, to organize to the consortium, to face and solve the issues derived from the project progress including contingencies, and to interact with the European Commission. This WP will also elaborate the communication and dissemination strategy .
The consortium is structured in three layers of management: administrative, scientific and strategic, and a fourth transversal layer constituted by an ethical board.
1. Strategic level: General Board
2. Scientific level: Executive Committee and Work Package Committee
3. Administrative level: Project coordinator
4. Ethical level: Ethical Advisory Board, transversal
Beside the Consortium boards and committees, the ORTHOUNION clinical trial has two external committees to guarantee safety and quality of the data, and to collaborate in the blinded analysis of the results (CEC, EAB). And also one internal board that will participate in the selection of possible participants in the trial (CTEB).
Researchers involved in the Clinical Trial Executive Board
- Prof. Dr. Enrique Gómez Barrena.
- Orthop. Surgeon at Hospital Universitario La Paz – UAM, Madrid, Spain.
- Prof. Dr. Med. Florian Gehard.
- Orthop. Surgeon at Universitätsklinikum – Ulm.
- Prof. Dr. Philippe Rosset.
- Orthop. Surgeon at C.H.U. Trousseau, Tours.
- Prof. Dr. Nicola Baldini.
- Orthop. Surgeon at Istituto Ortopedico Rizzoli, Bologna.
- Dra. Cristina Avendaño Solá.
- Head of Clinical Pharmacology Unit at Hospital Universitario Puerta de Hierro, Madrid.
When the Ethical Advisory Board (external board) is accompanied by the Project Coordinator and the Co-Cordinator (ORTHOUNION partners), it turns into the Data Safety Monitoring Board and is integrated by:
- Emeritus-Prof. Dr. Manuel N. Fernández.
- Universidad Autónoma de Madrid, Spain.
- Dra. Rosario Madero Jarabo.
- Experienced member of La Paz Ethics Committee.
- IdiPAZ, Hospital La Paz Institute for Health Research, Spain.
- Prof. Dr. Luc Favard.
- Orthopaedic Surgery.
- CHU TROUSSEAU, Univ. Tours, France.
- Prof. Dra. Isabel Varela Nieto.
- CSIC-Univerisdad Autónoma de Madrid, Spain.
- Experienced expert in Bioethics, European Science Foundation.
- Pending acceptance.
- Prof. Dr. Enrique Gómez Barrena (Coordinator).
- Dr. Cristina Avendaño Solá (Co-coordinator).