Clinical trial NCT01159899: Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Osteoarthritis
Knee Osteoarthritis
Osteochondritis Dissecans
Osteonecrosis
Keywords: Osteoarthritis
knee arthritis
Knee arthrosis
articular cartilage defects
osteochondral defects
mesenchymal stem cells
stem cells
cellules souches,
genou
arthrose genou
PRP platelet rich plasma
thérapie cellulaire
implantation cellules souches mésenchymateuses
régénération cartilage
cicatrisation ménisque
ligament
plasma riche plaquettaire
platelet rich plasma
stem cell
regrowt cartilage
cellules souches
PRP
Lead sponsor: University of Marseille
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IKS, International Knee Score
timeFrame: 6 months
measure: IKS, International Knee Score
timeFrame: 1 year
Secondary outcomes:
measure: KOOS, Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: KOOS, Knee Injury and Osteoarthritis Outcome Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Knee and Lower Limb Institute, Dr Michel Assor
Study officials:
affiliation: Knee and Lower Limb Institute, Marseille, France
name: Michel Assor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel
name: Shimon Slavin, MD
role: STUDY_DIRECTOR
References: