NCT00891501

The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Degenerative Arthritis
• Chondral Defects
• Osteochondral Defects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-05-01
• Last updated: 2009-05-01

Locations

1 site across 1 country: Egypt