"One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions (BMDC)
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|ClinicalTrials.gov Identifier: NCT02005861|
Recruitment Status : Unknown
Verified August 2017 by Istituto Ortopedico Rizzoli.
Recruitment status was: Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : August 22, 2017
BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying subchondral bone of the talar dome.
The use of concentrated bone marrow derived cells has been gaining successful results with arthroscopic implantation, since it is possible to transplant not only mesenchymal stem cells but also accessory cells that support angiogenesis and vasculogenesis by producing several growth factors.
OBJECTIVES Objective of this project is to identify the critical points of the regenerative treatment of osteochondral lesions of the ankle, in order to develop a standard and predictable procedure able to overcome the drawbacks of the previous techniques.
METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral lesion of the talus. The surgical procedure will be executed as following: the day before the surgery the platelet gel will be produced. The day of the surgery bone marrow will be aspirate from the posterior iliac crest and concentrated directly in the operating room by centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.
Then a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape.
After the scaffold implantation platelet gel will be sprayed on the top of implant, in order to provide extra growth factors and to improve the stability of the implant.
All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and at maximum follow-up. Different score scales will be used to objectivate the clinical results (AOFAS, SF-36, VAS). X-rays and MRI scan will be also taken preoperatively, and MRI will be executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI called T2 mapping will be performed at 24 months.
EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow derived cells (BMDCs) transplantation in a long term follow up study, with particular attention to identify the patient population that can gain the maximum benefit from this treatment, avoiding expensive and unnecessary procedures that too often are performed.
|Condition or disease||Intervention/treatment||Phase|
|Osteochondritis||Procedure: bone marrow cells transplantation on collagen scaffold||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: bone marrow cells transplantation
surgical procedure :the day before the surgery: platelet gel production. The day of the surgery: bone marrow aspiration from the posterior iliac crest of the patient and concentration. After the bone marrow harvesting, ankle arthroscopy will be performed. The lesion will be detected and cleaned.
An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and implanted.
After that platelet gel will be loaded on the top of implant
Procedure: bone marrow cells transplantation on collagen scaffold
120 ml of venous blood will be collected for the platelet gel production. The day of the surgery, 60 ml of bone marrow will be aspirate from the posterior iliac crest and concentrated. a standard ankle arthroscopy will be performed, with the patient in the supine position. The lesion will be detected and cleaned.
An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape to fit the lesion.
After the scaffold implantation 2 ml of platelet gel will be loaded on the top of implant, in order to provide growth factors and to improve the stability of the implant.
- American Orthopaedic Foot and Ankle Society hindfoot score [ Time Frame: 24 months after surgery ]American Orthopaedic Foot and Ankle Society hindfoot score will be used to assess the quality of life of the patients with a minimum score of 0 and a maximum of 100.
- T2 mapping MRI value [ Time Frame: 12 and 24 months after surgery ]MRI will be performed with T2 mapping sequences and T2 values will be recorded as indicator of quality through water content of the regenerated tissue.
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): NCT02005861
|I Clinic, Rizzoli Orthopaedic Institute|
|Bologna, Italy, 40136|
|Principal Investigator:||Sandro Giannini, Prof||Rizzoli Orthopaedic Institute, Bologna, Italy|