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

NCT ID: NCT00891501

Last Updated: 2009-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2014-12-31

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single

Clinical case series

Group Type: EXPERIMENTAL

Bone Marrow Aspiration

Intervention Type: PROCEDURE

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

Bone marrow mesenchymal stem cell implantation

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Bone marrow Biopsy; Autologous stem cell implantation for cartilage repair

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Department of Orthopedic Surgery, Cairo University School of Medicine

Principal Investigators

Abdel Aziz El Singergy, M.D

Role: STUDY_DIRECTOR

Department of Orthopedic Surgery Cairo University School of Medicine

Amgad M Haleem, M.Sc(Ortho)

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedic Surgery Cairo University School of Medicne

Hazem M Atta, Ph.D

Role: STUDY_DIRECTOR

Tissue Culture Unit - Department of Medical Biochemistry - Cairo University School of Medicine

Locations

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

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amgad M. Haleem, M.Sc (Ortho)

Role: CONTACT

amgad_haleem@hotmail.com

(+1) 980-230-8310

Hazem M Atta, Ph.D

Role: CONTACT

hazemmahmoudatta@yahoo.ie

+(20)123113378

Facility Contacts

Hazem Abdel Azeem, M.D

Role: primary

hazem@hazemabdelazeem.com

+(20)122127044

Hazem M Atta, Ph.D

Role: backup

hazemmahmoudatta@yahoo.ie

+(20)123113378

References

Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.

Reference Type: RESULT

PMID: 8150826 (View on PubMed)

Wakitani S, Mitsuoka T, Nakamura N, Toritsuka Y, Nakamura Y, Horibe S. Autologous bone marrow stromal cell transplantation for repair of full-thickness articular cartilage defects in human patellae: two case reports. Cell Transplant. 2004;13(5):595-600. doi: 10.3727/000000004783983747.

Reference Type: RESULT

PMID: 15565871 (View on PubMed)

Kuroda R, Ishida K, Matsumoto T, Akisue T, Fujioka H, Mizuno K, Ohgushi H, Wakitani S, Kurosaka M. Treatment of a full-thickness articular cartilage defect in the femoral condyle of an athlete with autologous bone-marrow stromal cells. Osteoarthritis Cartilage. 2007 Feb;15(2):226-31. doi: 10.1016/j.joca.2006.08.008. Epub 2006 Sep 26.

Reference Type: RESULT

PMID: 17002893 (View on PubMed)

Other Identifiers

Amgad

Identifier Type: -

Identifier Source: org_study_id