NCT02646007

Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease

Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock's Disease)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Kienböck's Disease

Interventions

Type	Name	Description
BIOLOGICAL	BM-MSC transplantation	Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2016-01-05
• Last updated: 2016-07-20

Locations

1 site across 1 country: Iran