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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2009 by Cairo University
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT00891501
First received: April 30, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
Degenerative Arthritis
Chondral Defects
Osteochondral Defects
Procedure: Bone Marrow Aspiration
Procedure: Bone marrow mesenchymal stem cell implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Improvement in Clinical Scores and Radiological images [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
Experimental: Single
Clinical case series
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
Other Name: Bone marrow Biopsy
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
Other Name: Autologous stem cell implantation for cartilage repair

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.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891501

Contacts
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

Locations
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         
Sponsors and Collaborators
Cairo University
Investigators
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
  More Information

Publications:
Responsible Party: Amgad Mohammed Haleem Ahmed Amin, M.B.B.S, M.Sc (Ortho), Associate Lecturer of Orthopedic Surgery, Department of Orthopedic Surgery, Cairo University School of Medicine
ClinicalTrials.gov Identifier: NCT00891501     History of Changes
Other Study ID Numbers: Amgad
Study First Received: April 30, 2009
Last Updated: April 30, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
autologous bone marrow mesenchymal stem cells
cartilage repair
osteoarthritis
osteochondral defects

Additional relevant MeSH terms:
Cartilage Diseases
Osteoarthritis
Osteochondrosis
Arthritis
Bone Diseases
Connective Tissue Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014