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

NCT00891501 | Unknown Phase 2

• 1 other identifier: Amgad
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Arthritis; Chondral Defects; Osteochondral Defects

Keywords

autologous bone marrow mesenchymal stem cells; cartilage repair; osteoarthritis; osteochondral defects

Outcome Measures

Primary Outcomes (1)

• Improvement in Clinical Scores and Radiological images

  1 year

Study Arms (1)

Single

EXPERIMENTAL

Clinical case series

Procedure: Bone Marrow Aspiration; Procedure: Bone marrow mesenchymal stem cell implantation

Interventions

Bone Marrow Aspiration 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

Also known as: Bone marrow Biopsy

Single

Bone marrow mesenchymal stem cell implantation 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

Also known as: Autologous stem cell implantation for cartilage repair

Single

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Patients younger than 15 years and older than 55 years.
• Diffuse and advanced articular cartilage degeneration of the joint
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (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, 11956, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 8150826 RESULT

• 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.

  PMID: 15565871 RESULT

• 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.

  PMID: 17002893 RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Abdel Aziz El Singergy, M.D

  Department of Orthopedic Surgery Cairo University School of Medicine

  STUDY DIRECTOR

• Amgad M Haleem, M.Sc(Ortho)

  Department of Orthopedic Surgery Cairo University School of Medicne

  PRINCIPAL INVESTIGATOR

• Hazem M Atta, Ph.D

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

  STUDY DIRECTOR

Central Study Contacts

Amgad M. Haleem, M.Sc (Ortho)

CONTACT

(+1) 980-230-8310; amgad_haleem@hotmail.com

Hazem M Atta, Ph.D

CONTACT

+(20)123113378; hazemmahmoudatta@yahoo.ie

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: November 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 1, 2009

Record last verified: 2009-04

Locations

EG (1)