ArticleJournal of translational medicine2016
Safety and feasibility of cell-based therapy of autologous bone marrow-derived mononuclear cells in plate-stabilized proximal humeral fractures in humans.
Article in Journal of translational medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 38 citations in OpenAlex.
- Cell-Based Therapy by Autologous Bone Marrow-Derived Mononuclear Cells for Bone Augmentation of Plate-Stabilized Proximal Humeral Fractures: A Multicentric, Randomized, Open Phase IIa study.Stem cells translational medicine · 2024Trial
- Cell Supported Single Membrane Technique for the Treatment of Large Bone Defects: Depletion of CD8Cells · 2026Article
- Review
- Cellular therapies for bone repair: current insights.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2024Review
- The Impact of Defect Size on Bone Healing in Critical-Size Bone Defects Investigated on a Rat Femur Defect Model Comparing Two Treatment Methods.Bioengineering (Basel, Switzerland) · 2024Article
- A New Perspective for Bone Tissue Engineering: Human Mesenchymal Stromal Cells Well-Survive Cryopreservation on β-TCP Scaffold and Show Increased Ability for Osteogenic Differentiation.International journal of molecular sciences · 2022Article
- Stem Cell Therapy in Limb Ischemia: State-of-Art, Perspective, and Possible Impacts of Endometrial-Derived Stem Cells.Frontiers in cell and developmental biology · 2022Review
- Article
- Clinical Application of Bone Marrow Mesenchymal Stem/Stromal Cells to Repair Skeletal Tissue.International journal of molecular sciences · 2020Review
- Systematic review assessing the evidence for the use of stem cells in fracture healing.Bone & joint open · 2020Article
- Introduction of a New Surgical Method to Improve Bone Healing in a Large Bone Defect by Replacement of the Induced Membrane by a Human Decellularized Dermis Repopulated with Bone Marrow Mononuclear Cells in Rat.Materials (Basel, Switzerland) · 2020Article
- Current and future uses of skeletal stem cells for bone regeneration.World journal of stem cells · 2020Review
- Synthetic Bone Substitutes and Mechanical Devices for the Augmentation of Osteoporotic Proximal Humeral Fractures: A Systematic Review of Clinical Studies.Journal of functional biomaterials · 2020Review
- Determination of the effective dose of bone marrow mononuclear cell therapy for bone healing in vivo.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2020Article
- Electrical stimulation in bone tissue engineering treatments.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2020Review
- Role of Adult Tissue-Derived Pluripotent Stem Cells in Bone Regeneration.Stem cell reviews and reports · 2020Article
- Nonunions of the humerus - Treatment concepts and results of the last five years.Chinese journal of traumatology = Zhonghua chuang shang za zhi · 2019Article
- E-cadherin regulates biological behaviors of neural stem cells and promotes motor function recovery following spinal cord injury.Experimental and therapeutic medicine · 2019Article
- Innovative Biomaterials for Bone Regrowth.International journal of molecular sciences · 2019Review
- Autologous cell-based therapy for treatment of large bone defects: from bench to bedside.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2018Review
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLocal implantation of ex vivo concentrated, washed and filtrated human bone marrow-derived mononuclear cells (BMC) seeded onto β-tricalciumphosphate (TCP) significantly enhanced bone healing in a preclinical segmental defect model. Based on these results, we evaluated in a first clinical phase-I trial safety and feasibility of augmentation with preoperatively isolated autologous BMC seeded onto β-TCP in combination with angle stable plate fixation for the therapy of proximal humeral fractures as a potential alternative to autologous bone graft from the iliac crest.
methods10 patients were enrolled to assess whether cell therapy with 1.3 × 10
resultsβ-tricalciumphosphate fortification with BMC was feasible and safe; specifically, neither morbidity at the harvest site nor at the surgical wound site were observed. Neither local nor systemic inflammation was noted. All fractures healed within the observation time without secondary dislocation. Three adverse events were reported: one case each of abdominal wall shingles, tendon loosening and initial screw perforation, none of which presumed related to the IND.
conclusionsCell therapy with autologous BMC for bone regeneration appeared to be safe and feasible with no drug-related adverse reactions being described to date. The impression of efficacy was given, although the study was not powered nor controlled to detect such. A clinical trial phase-II will be forthcoming in order to formally test the clinical benefit of BMC-laden β-TCP for PHF patients. Trial registration The study was registered in the European Clinical Trial Register as EudraCT No. 2012-004037-17. Date of registration 30th of August 2012. Informed consent was signed from all patients enrolled.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.