Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02646007|
Recruitment Status : Unknown
Verified July 2016 by Royan Institute.
Recruitment status was: Recruiting
First Posted : January 5, 2016
Last Update Posted : July 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Kienböck's Disease||Biological: BM-MSC transplantation||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock`s Disease)|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
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 [ Time Frame: 3months ]The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
- Bone density [ Time Frame: 3 months ]The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
- Quality of life evaluated by Visual Analogue Score (VAS) [ Time Frame: 3 months ]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.
- Infection: Presence of any sign or symptoms of infection [ Time Frame: 1week ]presence of any sign or symptoms of infection in site of surgery during 1 week.
- Cyst formation: Presence of any cyst or mass formation [ Time Frame: 3months ]presence of any cyst or mass formation at least 3 months after BM-MSC transplantation with surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646007
|Contact: Nasser Aghdami, MD,PhD||(+98)23562000 ext firstname.lastname@example.org|
|Contact: Leila Arab, MD||(+98)23562000 ext email@example.com|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of department of Regenerative Medicine & Cell therapy center, Royan Institute|
|Study Director:||Hamidreza Mehrpour, MD||Tehran university of medical science, department of orthopedic surgery|
|Principal Investigator:||Mohsen Emadedin, MD||Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.|
|Principal Investigator:||Narges Labibzadeh, MD||Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.|