Status:
UNKNOWN
The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects
Lead Sponsor:
Cairo University
Conditions:
Degenerative Arthritis
Chondral Defects
Eligibility:
All Genders
15-55 years
Phase:
PHASE2
PHASE3
Brief 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 cart...
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 ...
Eligibility Criteria
Inclusion
- Active patients (15 to 55 years).
- An isolated osteochondral defect (i.e., in a joint with an otherwise healthy articular surface - with cartilage on the opposing surface no more than grade 1 or 2 Outerbridge at the most.
- A defect that is 1 - 4 cm2 or more (up to 16 cm2).
Exclusion
- Patients younger than 15 years and older than 55 years.
- Diffuse and advanced articular cartilage degeneration of the joint
- Axial malalignment, meniscal pathology, and ligamentous instability are RELATIVE contraindications that have to be dealt with primarily either concomitantly or before the transplantation during 1 of the 2 stages of the procedure. Refusal of the patient to address these conditions in presence of a cartilage lesion is a criterion for exclusion from the study.
- Kissing lesions (i.e., on both opposing surfaces of a joint).
- Existing infection in or around the joint \& lesions of infectious or oncologic etiology.
- Debilitated patients.
- Immunocompromised patients.
- Patients with autoimmune disorders \& systemic inflammatory disease.
- Preoperative poor neurological or vascular status of the affected limb.
- Specific contraindications include the use of tobacco and medications that may impair cell proliferation, such as NSAIDs and immunosuppressive drugs. 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00891501
Start Date
November 1 2006
End Date
December 1 2014
Last Update
May 1 2009
Active Locations (1)
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1
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
Cairo, Cairo Governorate, Egypt, 11956