OsteoarthritisEarly Phase 1NCT01159899
Transplantation of Bone Marrow Stem Cells Stimulated by Proteins Scaffold to Heal Defects Articular Cartilage of the Knee
A Early Phase 1 study testing Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis in people with Osteoarthritis and Knee Osteoarthritis, run by Michel Assor, MD at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee Osteoarthritis, Osteochondritis Dissecans
- What is being tested?
- Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Dec 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Shimon Slavin, Pr contact
France1 site, 1 recruiting
- Recruiting
Knee and Lower Limb Institute, Dr Michel Assor
Marseille, 13008
Michel Assor, MD, 0033491221212 / 0033609505060, michel.assor@free.fr
Michel Assor, MD, 0033611950518
About this study
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.
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.
Read the 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.
- Being tested
- Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis
- 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
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteochondritis Dissecans, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of Bone Marrow Stem Cells Activated in Knee ArthrosisProcedure or surgery
Also called mesenchymal stem cells, Knee Arthrosis, Knee osteochondral defect
Transplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
IKS, International Knee Score
measure assess of the knee function
Measured: 6 months
IKS, International Knee Score
measure assess of the knee function
Measured: 1 year
Secondary outcomes (2)
KOOS, Knee Injury and Osteoarthritis Outcome Score
measure assess of the knee function and quality of the new cartilage
Measured: 6 months
KOOS, Knee Injury and Osteoarthritis Outcome Score
measure assess of the knee function and quality of the new cartilage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michel Assor, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michel Assor, MD, University of Marseille
- Investigators
- Michel Assor, MD, Principal investigator, Knee and Lower Limb Institute, Marseille, FranceShimon Slavin, MD, Study director, The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159899
- Sponsor's protocol ID
- MSC- AS3
- Status last verified
- Jan 2013
- First submitted
- 6 Jul 2010
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01159899
- Acronym / sponsor ID
- MSC- AS3
- Keywords
- Osteoarthritis, knee arthritis, Knee arthrosis, articular cartilage defects, osteochondral defects, mesenchymal stem cells, stem cells, cellules souches,
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Michel Assor, MDUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplantation of Bone Marrow Stem Cells Activated in Knee ArthrosisAlso: mesenchymal stem cells, Knee Arthrosis, Knee osteochondral defectTransplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
KOOS, Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 months
KOOS, Knee Injury and Osteoarthritis Outcome Score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- knee stem cell proceduresLink provided by the sponsor.
- cell therapy and PRPLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shimon Slavin, Pr contact
Michel Assor, MD principal investigator
Knee and Lower Limb Institute, Marseille, France
Shimon Slavin, MD study director
The International Center for Cell Therapy & Cancer (ICTC), Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis in people with Osteoarthritis and Knee Osteoarthritis, run by Michel Assor, MD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Assor, MD (0033611950518 / 0033609505060, michel.assor@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKS, International Knee Score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.