Osteo Arthritis KneePhase 3MICROPREP3NCT06084637
Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
A Phase 3 study testing Intra-articular injection of autologous microfat, Intra-articular injection of autologous platelet-rich plasma and Intra-articular injection of autologous microfat and platelet-rich plasma in people with Osteo Arthritis Knee, run by Assistance Publique Hopitaux De Marseille.
Trial summary
This research protocol evaluate the efficacity of intra-articular injections of autologous microfat associated with a preparation of autologous PRP, in symptomatic, resistant to first-line medical treatment, degenerative or post-traumatic cartilage lesions of the knee. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Intra-articular injection of autologous microfat, Intra-articular injection of autologous platelet-rich plasma and Intra-articular injection of autologous microfat and platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2024to 1 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both gender, between 20 and 75 year-old.
- Symptomatics degenerativ or post traumatic chondropathy, on at least one of the 3 knee compartments ICRS grade 2, 3 or 4 with VAS>4 and failure of well-conducted medical treatment for at least 1 year (palliative analgesics adapted to the pain, AINS, rehabilitation by a physiotherapist, injections intra-articulaires de corticoïdes et/ou d'acide hyaluronique)
- Varus or valgus less than or equal to 5°.
- BMI greater than 20 (in order to have sufficient fatty tissue)
- Informed consent signed by the patient
- HB > 10g/dl
- Negative beta-HCG at inclusion and effective contraception for patients of childbearing age, for 1 month.
- Beneficiaries of or affiliated to a social security system
Who cannot join
- Contraindications to MRI : ocular foreign bodies, pacemaker, neurostimulator, cochlear implant, vascular clips, metallic heart valve
- Body mass index (BMI) of less than 20 kg/m2 not allowig to obtain a sufficient quantity of adipose tissue.
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Known thrombopathy
- TP=> PR < 70%.
Show all 31Show fewer
- TCA=> APR > 1.20s
- Anemia HB < 10g/dl
- Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I and II virus infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection.
- Use of antiplatelet agents, aspirin, anti-vitamin K drugs for less than 15 days.
- Chronic treatment with oral corticosteroids or the use of such treatment less than 2 weeks prior to inclusion
- Intra-articular corticosteroid injection less than 2 months prior to inclusion
- Intra-articular injection of hyaluronic acid less than 2 months prior to inclusion
- Non-steroidal anti-inflammatory drugs less than 15 days prior to inclusion
- Recent fever or infection (bacterial or viral) less than one month old
- Autoimmune diseases
- Inflammatory arthritis
- Immune deficiency
- Ongoing or chronic infectious diseases (viral or bacterial)
- T Malignant tumours or history of malignant tumours less than 5 years prior to inclusion
- Pregnant or lactating women
- Adults protected by law (guardianship or curatorship)
- Patient participating simultaneously in another research project involving the human person
- Minors
- Persons residing in a health or social institution
- Persons in emergency situations
- Persons deprived of liberty
- Persons not covered by the French social security scheme
- Contraindication to local anesthesia and/or surgery
- Allergy to local anesthetics
- Inmates
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
This research protocol evaluate the efficacity of intra-articular injections of autologous microfat associated with a preparation of autologous PRP, in symptomatic, resistant to first-line medical treatment, degenerative or post-traumatic cartilage lesions of the knee.
The primary objective of this study is to show the superiority of intra-articular injection of autologous microfat combined with autologous PRP preparation compared to injection of microfat or PRP used alone, on the KOOS score at 6 months.
Read the detailed description
Osteoarthritis is the most widespread joint disease in the world, and one of the most frequent causes of pain and functional disability in Western countries. The incidence of cartilage lesions is constantly on the rise, due to the ageing of the population and the traumas associated with the development of sporting activities.
Recently, the emergence of biotherapies in orthopaedics has led to the development of intra-articular injections of autologous platelet-rich plasma (PRP). Their use has been widespread since 2010, based on the demonstration that platelet-enriched plasma, a concentrate of growth factors, can stimulate cartilage regeneration in vitro and in vivo in preclinical models (Saito, Schmidt, Qi, Tchetina). In addition, PRP administration methods can be optimized: since it is a liquid preparation (platelet suspension), administering it within an interface tissue limits its diffusion and potentiates its trophic effect on the injured cartilage site. Adipose tissue represents the most relevant tissue of interest, as it is a stem cell-rich support tissue with full therapeutic potential, and is easily accessible. Thus, a sample of autologous "microfat" (adipose tissue containing small fat lobules and stem cells, harvested under local anaesthetic by manual liposuction using specific fine sampling cannulas) co-administered at the level of the synovial capsule, could play the role of fluid trophic matrix to the PRP.
The hypothesis of this project is that the standardized injection of an innovative treatment (microgrease and autologous PRP dose) can defer the need for knee arthroplasty in patients with gonarthrosis resistant to first-line medical treatment. The investigators propose to carry out a clinical study in patients with chondral knee lesions resistant to first-line medical treatment, evaluating the benefit during follow-up of treatment with intra-articular injections of microfat and a standardized preparation of autologous PRP or the combination of the 2.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Intra-articular injection of autologous microfat, Intra-articular injection of autologous platelet-rich plasma, Intra-articular injection of autologous microfat and platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection of autologous microfatBiological
A preparation of autologous microfat (5mL) will be injected intra-articularly.
Intra-articular injection of autologous platelet-rich plasmaBiological
A preparation of autologous platelet-rich plasma (5mL) will be injected intra-articularly.
Intra-articular injection of autologous microfat and platelet-rich plasmaBiological
A preparation of autologous platelet-rich plasma (5mL) and autologous microfat (5mL) will be injected intra-articularly.
| Study group | Role | What they receive |
|---|---|---|
| autologous microfat (MG) | Experimental | Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous MG will be injected intra-articularly by th same surgeon. Receives: Biological: Intra-articular injection of autologous microfat |
| Platelet-rich plasma (PRP) | Experimental | Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous PRP will be injected intra-articularly by th same surgeon. Receives: Biological: Intra-articular injection of autologous platelet-rich plasma |
| Microfat autologous-Platelet-rich plasma (MG-PRP) | Experimental | Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed for the preparation during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and autologous microfat associated with a preparation of autologous PRP will be injected intra-articularly by th same surgeon. Receives: Biological: Intra-articular injection of autologous microfat and platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS score at 6 months
KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
Measured: 6 months
Secondary outcomes (8)
Pain at 1 month
Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
Measured: 1 month
Pain at 3 months
Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
Measured: 3 months
Pain at 12 months
Pain will assassed by a visual anatomy scale from 0 (no pain) to 10 (pain as bad as it could possibly be)
Measured: 12 months
KOOS score at 1 month
KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
Measured: 1 month
KOOS score at 3 months
KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
Measured: 3 months
KOOS score at 12 months
KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
Measured: 12 months
Proportion of treatment failures
Patients are defined as treatment failures if, during the follow-up period, they undergo one of the following procedures on the treated knee, in the absence of intercurrent events: new injection (whatever the product injected), arthroscopy, arthroplasty, etc.
Measured: 12 months
Proportion of arthroplasties not performed in arthroplasty candidates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start2 Feb 2024 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084637
- Sponsor's protocol ID
- RCAPHM21_0431
- Acronym
- MICROPREP3
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06084637
- Acronym / sponsor ID
- MICROPREP3 / RCAPHM21_0431
- Conditions
- Osteo Arthritis Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 16 Oct 2023 (actual)
- 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.
This research protocol evaluate the efficacity of intra-articular injections of autologous microfat associated with a preparation of autologous PRP, in symptomatic, resistant to first-line medical treatment, degenerative or post-traumatic cartilage lesions of the knee.
The primary objective of this study is to show the superiority of intra-articular injection of autologous microfat combined with autologous PRP preparation compared to injection of microfat or PRP used alone, on the KOOS score at 6 months.
Detailed description
Osteoarthritis is the most widespread joint disease in the world, and one of the most frequent causes of pain and functional disability in Western countries. The incidence of cartilage lesions is constantly on the rise, due to the ageing of the population and the traumas associated with the development of sporting activities.
Recently, the emergence of biotherapies in orthopaedics has led to the development of intra-articular injections of autologous platelet-rich plasma (PRP). Their use has been widespread since 2010, based on the demonstration that platelet-enriched plasma, a concentrate of growth factors, can stimulate cartilage regeneration in vitro and in vivo in preclinical models (Saito, Schmidt, Qi, Tchetina). In addition, PRP administration methods can be optimized: since it is a liquid preparation (platelet suspension), administering it within an interface tissue limits its diffusion and potentiates its trophic effect on the injured cartilage site. Adipose tissue represents the most relevant tissue of interest, as it is a stem cell-rich support tissue with full therapeutic potential, and is easily accessible. Thus, a sample of autologous "microfat" (adipose tissue containing small fat lobules and stem cells, harvested under local anaesthetic by manual liposuction using specific fine sampling cannulas) co-administered at the level of the synovial capsule, could play the role of fluid trophic matrix to the PRP.
The hypothesis of this project is that the standardized injection of an innovative treatment (microgrease and autologous PRP dose) can defer the need for knee arthroplasty in patients with gonarthrosis resistant to first-line medical treatment. The investigators propose to carry out a clinical study in patients with chondral knee lesions resistant to first-line medical treatment, evaluating the benefit during follow-up of treatment with intra-articular injections of microfat and a standardized preparation of autologous PRP or the combination of the 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| autologous microfat (MG) | Experimental | Biological: Intra-articular injection of autologous microfatPatient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous MG will be injected intra-articularly by th same surgeon. |
| Platelet-rich plasma (PRP) | Experimental | Biological: Intra-articular injection of autologous platelet-rich plasmaPatient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous PRP will be injected intra-articularly by th same surgeon. |
| Microfat autologous-Platelet-rich plasma (MG-PRP) | Experimental | Biological: Intra-articular injection of autologous microfat and platelet-rich plasmaPatient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed for the preparation during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and autologous microfat associated with a preparation of autologous PRP will be injected intra-articularly by th same surgeon. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of both gender, between 20 and 75 year-old.
- Symptomatics degenerativ or post traumatic chondropathy, on at least one of the 3 knee compartments ICRS grade 2, 3 or 4 with VAS>4 and failure of well-conducted medical treatment for at least 1 year (palliative analgesics adapted to the pain, AINS, rehabilitation by a physiotherapist, injections intra-articulaires de corticoïdes et/ou d'acide hyaluronique)
- Varus or valgus less than or equal to 5°.
- BMI greater than 20 (in order to have sufficient fatty tissue)
- Informed consent signed by the patient
Key exclusion criteria (31 listed)
- Contraindications to MRI : ocular foreign bodies, pacemaker, neurostimulator, cochlear implant, vascular clips, metallic heart valve
- Body mass index (BMI) of less than 20 kg/m2 not allowig to obtain a sufficient quantity of adipose tissue.
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Known thrombopathy
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 |
|---|---|---|
| Intra-articular injection of autologous microfatA preparation of autologous microfat (5mL) will be injected intra-articularly. | Biological | autologous microfat (MG) |
| Intra-articular injection of autologous platelet-rich plasmaA preparation of autologous platelet-rich plasma (5mL) will be injected intra-articularly. | Biological | Platelet-rich plasma (PRP) |
| Intra-articular injection of autologous microfat and platelet-rich plasmaA preparation of autologous platelet-rich plasma (5mL) and autologous microfat (5mL) will be injected intra-articularly. | Biological | Microfat autologous-Platelet-rich plasma (MG-PRP) |
Primary outcome
KOOS score at 6 months
Time frame: 6 months
KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.
8 secondary outcomes
Pain at 1 month
Time frame: 1 month
Pain at 3 months
Time frame: 3 months
Pain at 12 months
Time frame: 12 months
KOOS score at 1 month
Time frame: 1 month
KOOS score at 3 months
Time frame: 3 months
KOOS score at 12 months
Time frame: 12 months
Proportion of treatment failures
Time frame: 12 months
Proportion of arthroplasties not performed in arthroplasty candidates
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-articular injection of autologous microfat, Intra-articular injection of autologous platelet-rich plasma and Intra-articular injection of autologous microfat and platelet-rich plasma in people with Osteo Arthritis Knee, run by Assistance Publique Hopitaux De Marseille.
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 8 inclusion and 31 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: opening soon, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre ROCHWERGER, Pr (04 91 96 63 00, richardalexandre.rochwerger@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS score at 6 months (time frame: 6 months). 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 27 Oct 2023.