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

Primary Purpose

Osteoarthritis, Knee Osteoarthritis, Osteochondritis Dissecans

Status
Unknown status
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
Sponsored by
Michel Assor, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring 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

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Knee and Lower Limb Institute, Dr Michel AssorRecruiting

Outcomes

Primary Outcome Measures

IKS, International Knee Score
measure assess of the knee function
IKS, International Knee Score
measure assess of the knee function

Secondary Outcome Measures

KOOS, Knee Injury and Osteoarthritis Outcome Score
measure assess of the knee function and quality of the new cartilage
KOOS, Knee Injury and Osteoarthritis Outcome Score
measure assess of the knee function and quality of the new cartilage

Full Information

First Posted
July 6, 2010
Last Updated
January 7, 2013
Sponsor
Michel Assor, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01159899
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michel Assor, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
Other Intervention Name(s)
mesenchymal stem cells, Knee Arthrosis, Knee osteochondral defect
Intervention Description
Transplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure
Primary Outcome Measure Information:
Title
IKS, International Knee Score
Description
measure assess of the knee function
Time Frame
6 months
Title
IKS, International Knee Score
Description
measure assess of the knee function
Time Frame
1 year
Secondary Outcome Measure Information:
Title
KOOS, Knee Injury and Osteoarthritis Outcome Score
Description
measure assess of the knee function and quality of the new cartilage
Time Frame
6 months
Title
KOOS, Knee Injury and Osteoarthritis Outcome Score
Description
measure assess of the knee function and quality of the new cartilage
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Assor, MD
Phone
0033611950518 / 0033609505060
Email
michel.assor@free.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Shimon Slavin, Pr
Email
slavin@CTCIcenter.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Assor, MD
Organizational Affiliation
Knee and Lower Limb Institute, Marseille, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shimon Slavin, MD
Organizational Affiliation
The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Knee and Lower Limb Institute, Dr Michel Assor
City
Marseille
ZIP/Postal Code
13008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Assor, MD
Phone
0033491221212 / 0033609505060
Email
michel.assor@free.fr
First Name & Middle Initial & Last Name & Degree
Michel Assor, MD
Phone
0033611950518
First Name & Middle Initial & Last Name & Degree
Michel Assor, MD

12. IPD Sharing Statement

Links:
URL
http://cellulesouche-genou.blogspot.com
Description
knee stem cell procedures
URL
http://cellulesouches.org
Description
cell therapy and PRP

Learn more about this trial

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

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