Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee

Osteoarthritis Clinical Trial

Official title:

Pilot Study of A One-Step Procedure for the Use of Autologous Bone Marrow Mesenchymal Stem Cells Stimulated by Proteins Scaffold to Heal Under Arthroscopy Full-Thickness Defects Articular Cartilage and Osteoarthrosis of the Knee.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01159899
• Other study ID #: MSC- AS3
• Status: Recruiting
• Phase: Phase 0
• First received: July 6, 2010
• Last updated: January 7, 2013
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: University of Marseille
• Contact: Michel Assor, MD
• Phone: 0033611950518 / 0033609505060
• Email: michel.assor[@]free.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to investigate the efficacy and safety of autologous transplantation, under arthroscopy, of Bone Marrow Mesenchymal stem cells, using, with a cell separator, a fresh non-culture expanded Autologous Bone Marrow derived Mesenchymal Stem, mixed and activated with proteins scaffold in patient with Knee cartilage defects and osteoarthritis. Based on extensive preclinical investigations, the technology of using freshly isolated bone marrow mononuclear cells mixed with proteins seems safe and most effective for a one-step correction of cartilage defect and restoration of the osteochondral complex, because the same mixture can generate cartilage in the vasculature-free knee joint, and bone in the environment of bone defects.

Description:

Before the implantation of the mesenchymal stem cells, a knee arthroscopy procedure is made for the debridement of the meniscal and cartilage lesions, with microperforation and abrasion, preparation of the osteochondral defect to receive the transplantation, patellar lateral release if necessary.

Then, the investigators use a fresh non-culture expanded autologous bone marrow derived mesenchymal mononuclear stem cells, stimulated with a protein matrix and mixed in a collagen hydroxyapatite scaffold. This cellular paste is transplanted in the prepared defect, under arthroscopy, with injection of platelet rich plasma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Active patients (30 to 75 years)

• A localized osteochondral defect of both condyle and/or tibia grade 4 (ICRS classification)

• with cartilage on the tibial surface no more than grade 3-4, of size < 3-4 cm2, with 3/4 of meniscus present.

• Stable knee ; previous ligament reconstruction, if stable

• A defect that is 1 - 4 cm2 or more, up to 6 cm2, located on the femoral condyle and /or less of 4 cm2 for tibial plate, and IKS score <75.

• Kissing lesions admitted

• Ability to understand and willingness to sign consent form

Exclusion Criteria:

• Patients younger than 30 years and older than 75 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, to avoid the impact of these knee pathologies on the final results

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Osteochondritis
• Osteochondritis Dissecans
• Osteonecrosis

Intervention

Procedure:
• Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
Transplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure

Locations

Country	Name	City	State
France	Knee and Lower Limb Institute, Dr Michel Assor	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Michel Assor, MD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IKS, International Knee Score	measure assess of the knee function	6 months	Yes
Primary	IKS, International Knee Score	measure assess of the knee function	1 year	Yes
Secondary	KOOS, Knee Injury and Osteoarthritis Outcome Score	measure assess of the knee function and quality of the new cartilage	6 months	Yes
Secondary	KOOS, Knee Injury and Osteoarthritis Outcome Score	measure assess of the knee function and quality of the new cartilage	1 year	Yes

External Links

•   cell therapy and PRP
•   knee procedures
•   knee stem cell procedures