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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2013 by Michel Assor, MD, University of Marseille.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Michel Assor, MD, University of Marseille

ClinicalTrials.gov Identifier:

NCT01159899

First received: July 6, 2010

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2010

Last Updated Date

January 7, 2013

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IKS, International Knee Score [ Time Frame: 6 months ]
measure assess of the knee function
IKS, International Knee Score [ Time Frame: 1 year ]
measure assess of the knee function

Original Primary Outcome Measures ^ICMJE

IKS, International Knee Score [ Time Frame: 6 months ]
measure assess of the knee function
IKS, International Knee Score [ Time Frame: 1 year ]
mesure assess of the knee function

Change History

Complete list of historical versions of study NCT01159899 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

KOOS, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 6 months ]
measure assess of the knee function and quality of the new cartilage
KOOS, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 1 year ]
measure assess of the knee function and quality of the new cartilage

Original Secondary Outcome Measures ^ICMJE

ICRS, International Cartilage Research Society [ Time Frame: 6 months ]
measure assess of the knee function and quality of the new cartilage
ICRS, International Cartilage Research Society [ Time Frame: 1 year ]
measure assess of the knee function and quality of the new cartilage

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Early Phase 1

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis
Knee Osteoarthritis
Osteochondritis Dissecans
Osteonecrosis

Intervention ^ICMJE

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

Other Names:

mesenchymal stem cells
Knee Arthrosis
Knee osteochondral defect

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

30 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01159899

Other Study ID Numbers ^ICMJE

MSC- AS3

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Michel Assor, MD, University of Marseille

Study Sponsor ^ICMJE

Michel Assor, MD

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Michel Assor, MD	Knee and Lower Limb Institute, Marseille, France
Study Director:	Shimon Slavin, MD	The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel

PRS Account

University of Marseille

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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