Treating non-union bone fractures with cell therapy
Kobe University News Nov 22, 2017
A Nature Outline featuring Kobe University research on non-union bone fractures was published online (https://www.nature.com/collections/qmpthxknbn) on October 26, 2017.
The findings were made by a team led by professor Kuroda Ryosuke, associate professor Matsumoto Tomoyuki and associate professor Niikura Takahiro (Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine) based on the original research published in the journal STEM CELLS Translational Medicine in 2013.
Most bone fractures typically heal, although 5% to 10% of fractures fail to heal, resulting in delayed union or persistent non-union.
Some preclinical evidence shows the therapeutic potential of peripheral blood CD34+ cells, a hematopoietic/endothelial progenitor cell-enriched population, for bone fracture healing; however, clinical outcome following transplantation of CD34+ cells in patients with fracture has never been reported.
The researchers reported the results of phase 1/2a clinical trial regarding transplantation of autologous, granulocyte colony stimulating factor-mobilized CD34+ cells with atelocollagen scaffold for patients with femoral or tibial fracture non-union (n=7). The primary endpoint of this study is radiological fracture healing (union) by evaluating anteroposterior and lateral views at week 12 following cell therapy. For the safety evaluation, incidence, severity, and outcome of all adverse events were recorded.
Radiological fracture healing at week 12 was achieved in five of seven cases (71.4%), which was greater than the threshold (18.1%) predefined by the historical outcome of the standard of care. The interval between cell transplantation and union, the secondary endpoint, was 12.6 ± 5.4 weeks (range, 8Â24 weeks) for clinical healing and 16.1 ± 10.2 weeks (range, 8Â36 weeks) for radiological healing. Neither deaths nor life-threatening adverse events were observed during the 1-year follow-up after the cell therapy.
These results suggest feasibility, safety, and potential effectiveness of CD34+ cell therapy in patients with non-union.
The article was titled, "Local Transplantation of Granulocyte Colony Stimulating Factor-Mobilized CD34+ Cells for Patients With Femoral and Tibial Non-Union: Pilot Clinical Trial."
Go to Original
The findings were made by a team led by professor Kuroda Ryosuke, associate professor Matsumoto Tomoyuki and associate professor Niikura Takahiro (Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine) based on the original research published in the journal STEM CELLS Translational Medicine in 2013.
Most bone fractures typically heal, although 5% to 10% of fractures fail to heal, resulting in delayed union or persistent non-union.
Some preclinical evidence shows the therapeutic potential of peripheral blood CD34+ cells, a hematopoietic/endothelial progenitor cell-enriched population, for bone fracture healing; however, clinical outcome following transplantation of CD34+ cells in patients with fracture has never been reported.
The researchers reported the results of phase 1/2a clinical trial regarding transplantation of autologous, granulocyte colony stimulating factor-mobilized CD34+ cells with atelocollagen scaffold for patients with femoral or tibial fracture non-union (n=7). The primary endpoint of this study is radiological fracture healing (union) by evaluating anteroposterior and lateral views at week 12 following cell therapy. For the safety evaluation, incidence, severity, and outcome of all adverse events were recorded.
Radiological fracture healing at week 12 was achieved in five of seven cases (71.4%), which was greater than the threshold (18.1%) predefined by the historical outcome of the standard of care. The interval between cell transplantation and union, the secondary endpoint, was 12.6 ± 5.4 weeks (range, 8Â24 weeks) for clinical healing and 16.1 ± 10.2 weeks (range, 8Â36 weeks) for radiological healing. Neither deaths nor life-threatening adverse events were observed during the 1-year follow-up after the cell therapy.
These results suggest feasibility, safety, and potential effectiveness of CD34+ cell therapy in patients with non-union.
The article was titled, "Local Transplantation of Granulocyte Colony Stimulating Factor-Mobilized CD34+ Cells for Patients With Femoral and Tibial Non-Union: Pilot Clinical Trial."
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