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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.


Phase 0
30 Years
75 Years
Open (Enrolling)
Both
Osteoarthritis, Knee Osteoarthritis, Osteochondritis Dissecans, Osteonecrosis

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Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

IKS, International Knee Score

Outcome Description:

measure assess of the knee function

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Michel Assor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Knee and Lower Limb Institute, Marseille, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

MSC- AS3

NCT ID:

NCT01159899

Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

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

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