ClinicalTrials.gg
Status unknownNCT01159899Updated Jan 8, 2013

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

An Early Phase 1 interventional study of Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis in Osteoarthritis, Knee Osteoarthritis and Osteochondritis Dissecans, sponsored by Michel Assor, MD. Status unknown at 1 site in France. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-01-08.

Primary conditionOsteoarthritis, KneeRegistry: OsteoarthritisReclassifiedWhy we changed it
Registry
Osteoarthritis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Osteoarthritis, Knee
Why
  1. The study's listed conditions name Osteoarthritis, Knee, a narrower term within Osteoarthritis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Michel Assor, MD · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
30 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 124 studies in Osteoarthritis, Knee with a site in France — 23 open to participants now, 33 under way, 1 of them phase 3. Osteoarthritis, Knee · France.

Planned enrollment
62nd of 86
50 · median 106
Started
2010
with 3 others
Phase 1
5 of 124
none open now
Registered
17th of 124
by date

Among the 124 studies in Osteoarthritis, Knee with a site in France, this one is the 62nd largest by planned enrollment of the 86 interventional ones that give a count, is one of 4 that started in 2010, is one of 5 in phase 1, and was the 17th registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

23 of the 124 studies in Osteoarthritis, Knee with a site in France are open now. Recruiting first, the newest first:

18 more — sign in →

All 23 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 30 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

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.

03

Conditions studied

  • Osteoarthritis
  • Knee Osteoarthritis
  • Osteochondritis Dissecans
  • Osteonecrosis

Browse trials for

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
04

In context

Osteoarthritis, Knee Reclassified

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 50 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Michel Assor, MD as lead sponsor.

Compared within Osteoarthritis, Knee, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
  • patients.
  • Patients with 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

06

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • ProcedureTransplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis

    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

07

What researchers measure

Primary outcomes

  1. IKS, International Knee Score

    measure assess of the knee function

    Time frame: 6 months

  2. IKS, International Knee Score

    measure assess of the knee function

    Time frame: 1 year

Secondary outcomes

  1. KOOS, Knee Injury and Osteoarthritis Outcome Score

    measure assess of the knee function and quality of the new cartilage

    Time frame: 6 months

  2. KOOS, Knee Injury and Osteoarthritis Outcome Score

    measure assess of the knee function and quality of the new cartilage

    Time frame: 1 year

08

Study locations

1 of 1 sites recruiting
  • Knee and Lower Limb Institute, Dr Michel Assor
    Marseille, 13008, France
    Recruiting
    • Michel Assor, MD · Contactmichel.assor@free.fr · 0033491221212 / 0033609505060
    • Michel Assor, MD · Contact0033611950518
    • Michel Assor, MD · Principal investigator
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2010, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2010
First posted
Jul 12, 2010
Start
Jul 2010
Primary completionEst.
Dec 2014
CompletionEst.
Dec 2014
Last update
Jan 8, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01159899
Lead sponsor
Michel Assor, MD
Responsible party
Michel Assor, MD (Sponsor-Investigator, University of Marseille) — Sponsor-investigator
First posted
Jul 12, 2010
Start date
Jul 2010
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Jan 8, 2013

Study contacts

Michel Assor, MD
Contact
michel.assor@free.fr
0033611950518 / 0033609505060
Shimon Slavin, Pr
Contact
slavin@CTCIcenter.com
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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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