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Sponsored by: |
Cairo University |
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Information provided by: | Cairo University |
ClinicalTrials.gov Identifier: | NCT00891501 |
This study is conducted to assess whether implanting autologous, culture-expanded, mesenchymal stem cells obtained from the bone marrow of patients with early osteoarthritis, cartilage defects or cartilage and underlying bone and cartilage (osteochondral) defects in joints is effective in the treatment of such conditions and alleviation of patients symptoms.
Condition | Intervention | Phase |
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Degenerative Arthritis Chondral Defects Osteochondral Defects |
Procedure: Bone Marrow Aspiration Procedure: Bone marrow mesenchymal stem cell implantation |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects |
Estimated Enrollment: | 25 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single: Experimental
Clinical case series
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Procedure: Bone Marrow Aspiration
Autologous bone marrow is aspirated from the iliac crest (hip bone) of the patient using a 21-gauge bone marrow aspiration needle under complete aseptic conditions and proper anaesthesia
Procedure: Bone marrow mesenchymal stem cell implantation
The culture expanded mesenchymal stem cell pellet will be implanted into the osteochondral knee defect via open surgery or arthroscopically under complete sterile aseptic conditions and proper anaesthesia. The defect will be covered with an autologous periosteal flap from the proximal tibia and then sealed with human fibrin glue to seal the defect and retain the cell pellet in place
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All procedures are carried out after obtaining informed written consent from patients. Bone marrow is aspirated from the iliac crest (hip bone) of patients with osteochondral defects intraoperatively under complete sterile, aseptic conditions and under proper anaesthesia (general, local). The bone marrow aspirate is placed in tubes and transferred under aseptic conditions to the Tissue Culture Unit in the Biochemistry Department at the Cairo University School of Medicine where it is processed and bone marrow mesenchymal stem cells are isolated and grown in culture for 2-3 weeks. After this time interval, the cells are reprocessed and the cell pellet is obtained. Implantation of the cell pellet into the osteochondral defect of the joint after embedding it on a proper scaffold is performed followed by subsequent defect coverage with an autologous periosteal flap obtained from the proximal tibia to seal the defect and maintain the cell pellet in place. The patients will be assessed clinically with scoring systems preoperatively as well as 6 and 12 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (X-rays and MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.
Ages Eligible for Study: | 15 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients must be nicotine-free (stop smoking) prior to the procedure, as studies have shown that the oxidative effect of smoking impairs cell function and subsequent healing.
Contact: Amgad M. Haleem, M.Sc (Ortho) | (+1) 980-230-8310 | amgad_haleem@hotmail.com |
Contact: Hazem M Atta, Ph.D | +(20)123113378 | hazemmahmoudatta@yahoo.ie |
Egypt | |
Deaprtment of Orthopedic Surgery and Tissue Culture Unit of the Department of Medical Biochemistry - Cairo University School of Medicne - Kasr Al Ainy Hospitals -Al-Saray Street, El Manial | Recruiting |
Cairo, Egypt, 11956 | |
Contact: Hazem Abdel Azeem, M.D +(20)122127044 hazem@hazemabdelazeem.com | |
Contact: Hazem M Atta, Ph.D +(20)123113378 hazemmahmoudatta@yahoo.ie | |
Principal Investigator: Amgad M. Haleem, M.Sc(Ortho) | |
Sub-Investigator: Abdel Aziz El Singergy, M.D | |
Sub-Investigator: Dina S Abdel Fattah, Ph.D | |
Sub-Investigator: Mohamamed T El Shiwy, M.D | |
Sub-Investigator: Hazem M Atta, Ph.D | |
Sub-Investigator: Akram Azzam, M.D |
Study Director: | Abdel Aziz El Singergy, M.D | Department of Orthopedic Surgery Cairo University School of Medicine |
Principal Investigator: | Amgad M Haleem, M.Sc(Ortho) | Department of Orthopedic Surgery Cairo University School of Medicne |
Study Director: | Hazem M Atta, Ph.D | Tissue Culture Unit - Department of Medical Biochemistry - Cairo University School of Medicine |
Responsible Party: | Department of Orthopedic Surgery, Cairo University School of Medicine ( Amgad Mohammed Haleem Ahmed Amin, M.B.B.S, M.Sc (Ortho), Associate Lecturer of Orthopedic Surgery ) |
Study ID Numbers: | Amgad |
Study First Received: | April 30, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00891501 History of Changes |
Health Authority: | Egypt: Institutional Review Board |
autologous bone marrow mesenchymal stem cells cartilage repair osteoarthritis osteochondral defects |
Musculoskeletal Diseases Fibrin Tissue Adhesive Osteoarthritis Joint Diseases |
Arthritis Anesthetics Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |