Kienböck's Disease Clinical Trial
Official title:
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock`s Disease)
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is
usually progressive without treatment.
Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells
are the best candidates for this kind of treatment.
This study examined lunate core decompression in combination with implantation of autologous
bone marrow derived mesenchymal stromal cells for Its treatment potential.
Bone decompression in combination with implantation of autologous bone marrow derived
mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.
The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Kienböck's disease is characterized by avascular necrosis of the lunate wrist There is
probably no single cause of avascular necrosis of the lunate. Its origin may involve
multiple factors, such as the blood supply (arteries), the blood drainage (veins), and
skeletal variations.
Current treatments are: at the early phase only observation. In the more advanced phases
surgical techniques such as bone decompression.
A potential therapeutic strategy would be cell therapy, A source of such cells with a
regenerative potential could be mesenchymal stem cells (MSCs).
The investigators will evaluate safety and efficacy of implantation of autologous BM-MSC
(bone marrow-derived mesenchymal stromal cell) in 30 patients with Kienböck's disease in
combination with bone decompression surgery. These patients will be followed up and data
will be analyzed with spss(v16).
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment