A Phase 1 interventional study of BM-MSC transplantation in Kienböck's Disease, sponsored by Royan Institute. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by Royan Institute · Phase 1, Interventional, and Treatment
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).
184 studies on the registry are indexed under Osteonecrosis; 31 are open to participants now.
This study's planned enrollment of 30 is below the median of 51 across 96 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease.
Biological: BM-MSC transplantation
Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.
Pain
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
Time frame: 3months
Bone density
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
Time frame: 3 months
Quality of life evaluated by Visual Analogue Score (VAS)
Improvement of quality of life inpatients after at least 3months of BM-MSC transplantation that is evaluated by Visual Analogue Score (VAS). The patients depends on their severity of the pain during daily activity choose a score between 1-10. The score will be saved in score sheets.
Time frame: 3 months
Infection: Presence of any sign or symptoms of infection
presence of any sign or symptoms of infection in site of surgery during 1 week.
Time frame: 1week
Cyst formation: Presence of any cyst or mass formation
presence of any cyst or mass formation at least 3 months after BM-MSC transplantation with surgery.
Time frame: 3months
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Royan Institute