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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Kienböck's Disease

Intervention / Treatment
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* Biological: BM-MSC transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months Both genders Visual Analogue Scale of 4 or higher Hematological and biochemical analysis with no significant alterations that contraindicates intervention The patient is able to understand the nature of the study Informed written consent of the patient Exclusion Criteria: Age over 65 or under 18 or legally dependent Infection signs or positive serology for HIV, hepatitis and syphilis Allergy to gentamicin, or to bovine, cattle or horse serum Pregnancy or lactating Pregnancy or breast-feeding Neoplasia Immunosuppression Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study Other conditions that may, according to medical criteria, discourage participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BM-MSC<br>Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease. | Biological: BM-MSC transplantation<br>* Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression. | 3months | 
| Bone density | The improvement of bone density at least 3months after BM-MSC transplantation in MRI. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Cell therapy Kienböck's disease, bone marrow derived mesenchymal stromal/stem cell