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

Primary Purpose

Degenerative Arthritis, Chondral Defects, Osteochondral Defects

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Bone Marrow Aspiration

Bone marrow mesenchymal stem cell implantation

About this trial

This is an interventional treatment trial for Degenerative Arthritis focused on measuring autologous bone marrow mesenchymal stem cells, cartilage repair, osteoarthritis, osteochondral defects

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / 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 ManialRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

Clinical case series

Outcomes

Primary Outcome Measures

Improvement in Clinical Scores and Radiological images

Secondary Outcome Measures

Full Information

NCT ID

NCT00891501

First Posted

April 30, 2009

Last Updated

April 30, 2009

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT00891501

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Arthritis, Chondral Defects, Osteochondral Defects

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single

Arm Type

Experimental

Arm Description

Clinical case series

Intervention Type

Procedure

Intervention Name(s)

Bone Marrow Aspiration

Other Intervention Name(s)

Bone marrow Biopsy

Intervention Description

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

Intervention Name(s)

Bone marrow mesenchymal stem cell implantation

Other Intervention Name(s)

Autologous stem cell implantation for cartilage repair

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in Clinical Scores and Radiological images

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amgad M. Haleem, M.Sc (Ortho)

Phone

(+1) 980-230-8310

amgad_haleem@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hazem M Atta, Ph.D

Phone

+(20)123113378

hazemmahmoudatta@yahoo.ie

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdel Aziz El Singergy, M.D

Organizational Affiliation

Department of Orthopedic Surgery Cairo University School of Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Amgad M Haleem, M.Sc(Ortho)

Organizational Affiliation

Department of Orthopedic Surgery Cairo University School of Medicne

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hazem M Atta, Ph.D

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Cairo

ZIP/Postal Code

11956

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hazem Abdel Azeem, M.D

Phone

+(20)122127044

hazem@hazemabdelazeem.com

First Name & Middle Initial & Last Name & Degree

Hazem M Atta, Ph.D

Phone

+(20)123113378

hazemmahmoudatta@yahoo.ie

First Name & Middle Initial & Last Name & Degree

Amgad M. Haleem, M.Sc(Ortho)

First Name & Middle Initial & Last Name & Degree

Abdel Aziz El Singergy, M.D

First Name & Middle Initial & Last Name & Degree

Dina S Abdel Fattah, Ph.D

First Name & Middle Initial & Last Name & Degree

Mohamamed T El Shiwy, M.D

First Name & Middle Initial & Last Name & Degree

Hazem M Atta, Ph.D

First Name & Middle Initial & Last Name & Degree

Akram Azzam, M.D

12. IPD Sharing Statement

Citations:

PubMed Identifier

8150826

Citation

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.

Results Reference

result

PubMed Identifier

15565871

Citation

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.

Results Reference

result

PubMed Identifier

17002893

Citation

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.

Results Reference

result

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

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