NCT01159899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jul 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

4.4 years

First QC Date

July 6, 2010

Last Update Submit

January 7, 2013

Conditions

OsteoarthritisKnee OsteoarthritisOsteochondritis DissecansOsteonecrosis

Keywords

Osteoarthritisknee arthritisKnee arthrosisarticular cartilage defectsosteochondral defectsmesenchymal stem cellsstem cellscellules souches,genouarthrose genouPRP platelet rich plasmathérapie cellulaireimplantation cellules souches mésenchymateusesrégénération cartilagecicatrisation ménisqueligamentplasma riche plaquettaireplatelet rich plasmastem cellregrowt cartilagecellules souchesPRP

Outcome Measures

Primary Outcomes (2)

  • IKS, International Knee Score

    measure assess of the knee function

    6 months

  • IKS, International Knee Score

    measure assess of the knee function

    1 year

Secondary Outcomes (2)

  • KOOS, Knee Injury and Osteoarthritis Outcome Score

    6 months

  • KOOS, Knee Injury and Osteoarthritis Outcome Score

    1 year

Interventions

Transplantation of Bone Marrow Stem Cells Activated in Knee ArthrosisPROCEDURE

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

Also known as: mesenchymal stem cells, Knee Arthrosis, Knee osteochondral defect

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients younger than 30 years and older than 75 years
  • Diffuse and advanced articular cartilage degeneration of the joint
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Knee and Lower Limb Institute, Dr Michel Assor

Marseille, 13008, France

RECRUITING

Related Links

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, KneeOsteochondritis DissecansOsteonecrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteochondritisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michel Assor, MD

    Knee and Lower Limb Institute, Marseille, France

    PRINCIPAL INVESTIGATOR

  • Shimon Slavin, MD

    The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel

    STUDY DIRECTOR

Central Study Contacts

Michel Assor, MD

CONTACT

0033611950518 / 0033609505060michel.assor@free.fr

Shimon Slavin, Pr

CONTACT

slavin@CTCIcenter.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 12, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

FR(1)