Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing (OrthoCT1)
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|ClinicalTrials.gov Identifier: NCT01842477|
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : December 2, 2017
Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal tissue. In Europe, about one million patients encounter a surgical bone reconstruction annually and the numbers are increasing due to our ageing population. Bone grafting intends to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage, but this is only attained presently by including cells capable of forming bone into the augmentation.
Bone autograft is the safest and most effective grafting procedure, since it contains patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction). However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from the iliac crest) represents an additional surgical intervention, with frequent consequent pain and complications.
We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically implanted with synthetic bone substitutes contribute to the resolution of the health and socioeconomic complications of delayed union or non-union after diaphyseal and metaphyseal-diaphyseal fractures with safety and efficacy.
|Condition or disease||Intervention/treatment||Phase|
|Delayed Union After Fracture of Humerus, Tibial or Femur||Procedure: Implantation of bone substitute plus autologous cultured mesenchymal cells||Phase 1 Phase 2|
Tissue engineering combines bone marrow cells or mesenchymal stem cells (MSCs), synthetic scaffolds and molecular signals (growth or differentiating factors) in order to form hybrids constructs. For bone reconstruction purposes, human MSCs have been seeded and cultured on porous calcium phosphate ceramics in osteogenic media. Some clinical studies with low numbers of patients have been reported using this approach but the outcomes were inconsistent with low efficacy in bone regeneration. The reasons of the limited clinical success may be due to several bottlenecks in the multidisciplinary field of bone tissue engineering. The association in vitro of biomaterials and osteoprogenitor cells raises technical challenges and regulatory and ethic issues for the implementation of clinical trials, whereas the expansion of MSCs is now possible in GMP Facility.
The expected results are to obtain bone consolidation thus healing of delayed union or non-union, as proven by imaging techniques, without using bone graft. This will prove the efficacy of the proposed IMP based on pluripotent MSCs expanded in a GMP facility and mixed with granulated biphasic calcium phosphate in the surgical setting before implantation. No expected complications related to the procedure are expected. Changes in serum levels of bone turnover markers will be described.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||February 5, 2016|
|Actual Study Completion Date :||February 5, 2016|
Experimental: Implantation surgery
All the patients will have the implantation surgery. This trial is a one-arm study.
Procedure: Implantation of bone substitute plus autologous cultured mesenchymal cells
Implantation surgery of a synthetic bone substitute associated with autologous bone marrow cells expanded
- Complication rate as percentage of patients with local complications regarding the non-union treatment in the follow-up [ Time Frame: At 6 weeks, 12 weeks, 24 weeks and 52 weeks after the implantation surgery ]
- Number of patients with proven bone healing [ Time Frame: 6 weeks, 12 weeks, and 24 weeks after the implantation surgery ]
- Amount of radiological callus [ Time Frame: 6 weeks, 12 weeks, and 24 weeks after the implantation surgery ]
- Clinical consolidation [ Time Frame: 6 weeks, 12 weeks, and 24 weeks after implantation surgery ]
- No reoperation done or scheduled [ Time Frame: 24 weeks after implantation surgery ]
- Changes in serum levels of bone turnover markers [ Time Frame: 6 weeks, 12 weeks, and 24 weeks after the implantation surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842477
|Depatment of Orthopaedic Surgery, Hôpital Henri Mondor|
|Créteil, France, 94000|
|Department of Orthopaedic Surgery, CHRU Tours|
|Tours, France, 37044|
|Department of Orthopaedic Trauma, University of Ulm|
|Ulm, Germany, 89081|
|Istituto Ortopedico Rizzoli, Bologna|
|Bologna, Italy, 40136|
|Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz|
|Madrid, Spain, 28046|
|Principal Investigator:||Enrique Gomez Barrena||Universidad Autonoma de Madrid|