Knee OsteoarthritisPhase 1/2MICROPREPNCT04352075
Intra Articular Injection of Microfat and PRP in Knee Osteoarthritis
A Phase 1/2 study testing Autologous biologic drug of innovative therapy /cell therapy drug in people with Knee Osteoarthritis, run by Clinique Juge at 1 site in France.
Trial summary
The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Autologous biologic drug of innovative therapy /cell therapy drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2018to 1 Mar 2020
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 20 to 65 years of age
- Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4 with VAS > 4 and failure of medical treatment for at least one year
- BMI between 20 to 30
- Written informed consent, signed by patient or legal representative
- HB > 10g/dl
- Negative pregnancy test
- Social security affiliated
Who cannot join
- IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
- BMI < 20
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Thrombopathy
- TP < 70%
Show all 20Show fewer
- TCA patient / witness rapport > 1,20
- Anaemia: HB < 10g/dl
- Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
- Treatment by platelet inhibiting agent, aspirin, anti vitamin K completed more than 2 weeks before inclusion
- Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
- Intra articular knee injection of corticosteroid more than 8 weeks before inclusion
- Intra articular knee injection of hyaluronic acid more than 8 weeks before inclusion
- NSAI treatment completed more than 2 weeks before inclusion
- Fever or recent disease
- Auto immune disease
- Inflammatory Arthritis
- Immune deficit
- Infectious disease
- Malignant tumor being treated or history of malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study
The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.
Read the detailed description
Osteoarthritis is the most common joint disease in the world and one of the most common causes of pain and functional disability. The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The treatment of these cartilage damage is limited and remains a major public health issue.
The aim of the medical treatment and intra articular injections consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients. Nevertheless their efficacy remain non predictable in patients.
The arthroplasty will be proposed in the final intention. Insofar arthroplasty is a surgical procedure 1 / which presents a potential infectious risk associated with its invasive nature, 2 / it requires iterative revision surgery, especially in young patients given the limited lifetime of the implants and 3 / whose complete postoperative recovery take several months, it seems justified to continue studies to validate effective alternative treatments to delay the use of joint replacements.
Recently, the emergence of biotherapy in orthopedics has developed the use of intra-articular injections of platelet-rich plasma (PRP). Their use has increased substantially and is based on the demonstration that platelet-rich plasma concentrate growth factors, can stimulate cartilage regeneration in vitro and in vivo preclinical models. In humans, recent data from the literature show that these autologous products are very well tolerated. Their scientific evaluation remains difficult in that 1 / indications and surgical procedures are not harmonized 2 / manufacturing processes PRP are not standardized 3 / quantitative and qualitative composition of PRP is rarely documented.
PRP administration procedures can be optimized: indeed in that, it is a liquid preparation (platelet suspension), its administration in a interface tissue allows to limit its spread and potentiate its trophic effect on the injured cartilage site. Adipose tissue is the most relevant interface tissue given, because it's a tissue rich in stem cells with full therapeutic potential and is easily accessible by subcutaneous minimally invasive procedure. Thus, autologous microfat (fat removed under local anesthesia by manual liposuction using fine cannulas specific) administered in the synovial capsule, could play the matrix to receive the injection of PRP.
The hypothesis of this project is that the standardized injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment. This treatment, minimally invasive and with economically reasonable cost, would provide a new treatment for second intention. In terms medicoeconomic if this treatment is effective over a period of several years, even in cases where it is necessary to do it one or two times, it would significantly reduce the financial and societal impact of joint replacements.
- Conditions
- Knee Osteoarthritis
- Being tested
- Autologous biologic drug of innovative therapy /cell therapy drug
- Keywords
- knee, osteoarthritis, microfat, platelet rich plasma
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous biologic drug of innovative therapy /cell therapy drugDrug
Articular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution
| Study group | Role | What they receive |
|---|---|---|
| Microfat + PRP 3M platelets | Experimental | microfat (5 ml) associated with PRP with a dose of 3 billions of platelets (5 ml) Receives: Drug: Autologous biologic drug of innovative therapy /cell therapy drug |
| Microfat + PRP 1M platelets | Experimental | microfat (5 ml) associated with PRP with a dose of 1 billion of platelets (5 ml) Receives: Drug: Autologous biologic drug of innovative therapy /cell therapy drug |
| Microfat | Experimental | microfat (5 ml) and saline solution (5 ml) Receives: Drug: Autologous biologic drug of innovative therapy /cell therapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cartilage relaxation time on MRI T2-mapping at 3 months
The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months.
Measured: Baseline and 3 months post injection
Secondary outcomes (5)
Improved of chondral lesion on MRI
Improved chondral lesions at 3 months and 6 months on specific MRI cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping): quantitative morphological sequences resolution and qualitative structural sequences.
Measured: Baseline and 3 and 6 months post injection
Pain
The evolution of pain with the visual analogic scale compared to the initial state (scores at baseline) and the evolution of pain (VAS score) at 1, 3 and 6 months post-injection. Scale from 0 (no pain) to 10 (maximal pain)
Measured: Baseline and 1 and 3 and 6 months post injection
Responding patients
The proportion of patients not responding to treatment.
Measured: Baseline and 3 and 6 months post injection
Biologic parameters / clinical efficacity
The correlation between clinical efficacy and dose of PRP administered and dose of growth factors administered.
Measured: Baseline and 3 and 6 months post injection
WOMAC
The evolution of the functional impact of knee osteoarthritis with the Western Ontario and McMaster University Osteoarthritis score at 1, 3 and 6 months post-injection. Score from 0 to 96 (the worst)
Measured: Baseline and 1 and 3 and 6 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start15 Nov 2018
- Primary completion1 Aug 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric randomised, double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Juge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Laure LOUIS, Clinique Juge
- Investigators
- Marie Laure Louis, MD, Principal investigator, ICOS Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352075
- Sponsor's protocol ID
- 2016-004755-75
- Other IDs
- 2016-004755-75, 2016
- Acronym
- MICROPREP
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication
Publications
Louis ML, Dumonceau RG, Jouve E, Cohen M, Djouri R, Richardet N, Jourdan E, Giraudo L, Dumoulin C, Grimaud F, George FD, Veran J, Sabatier F, Magalon J. Intra-Articular Injection of Autologous Microfat and Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Comparative Study. Arthroscopy. 2021 Oct;37(10):3125-3137.e3. doi: 10.1016/j.arthro.2021.03.074. Epub 2021 Apr 20.
PubMed 33887408
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study
- ClinicalTrials.gov ID
- NCT04352075
- Acronym / sponsor ID
- MICROPREP / 2016-004755-75
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, microfat, platelet rich plasma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinique JugeUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Apr 2020 (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.
The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.
Detailed description
Osteoarthritis is the most common joint disease in the world and one of the most common causes of pain and functional disability. The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The treatment of these cartilage damage is limited and remains a major public health issue.
The aim of the medical treatment and intra articular injections consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients. Nevertheless their efficacy remain non predictable in patients.
The arthroplasty will be proposed in the final intention. Insofar arthroplasty is a surgical procedure 1 / which presents a potential infectious risk associated with its invasive nature, 2 / it requires iterative revision surgery, especially in young patients given the limited lifetime of the implants and 3 / whose complete postoperative recovery take several months, it seems justified to continue studies to validate effective alternative treatments to delay the use of joint replacements.
Recently, the emergence of biotherapy in orthopedics has developed the use of intra-articular injections of platelet-rich plasma (PRP). Their use has increased substantially and is based on the demonstration that platelet-rich plasma concentrate growth factors, can stimulate cartilage regeneration in vitro and in vivo preclinical models. In humans, recent data from the literature show that these autologous products are very well tolerated. Their scientific evaluation remains difficult in that 1 / indications and surgical procedures are not harmonized 2 / manufacturing processes PRP are not standardized 3 / quantitative and qualitative composition of PRP is rarely documented.
PRP administration procedures can be optimized: indeed in that, it is a liquid preparation (platelet suspension), its administration in a interface tissue allows to limit its spread and potentiate its trophic effect on the injured cartilage site. Adipose tissue is the most relevant interface tissue given, because it's a tissue rich in stem cells with full therapeutic potential and is easily accessible by subcutaneous minimally invasive procedure. Thus, autologous microfat (fat removed under local anesthesia by manual liposuction using fine cannulas specific) administered in the synovial capsule, could play the matrix to receive the injection of PRP.
The hypothesis of this project is that the standardized injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment. This treatment, minimally invasive and with economically reasonable cost, would provide a new treatment for second intention. In terms medicoeconomic if this treatment is effective over a period of several years, even in cases where it is necessary to do it one or two times, it would significantly reduce the financial and societal impact of joint replacements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, monocentric randomised, double blind
| Arm | Type | Receives |
|---|---|---|
| Microfat + PRP 3M platelets | Experimental | Drug: Autologous biologic drug of innovative therapy /cell therapy drugmicrofat (5 ml) associated with PRP with a dose of 3 billions of platelets (5 ml) |
| Microfat + PRP 1M platelets | Experimental | Drug: Autologous biologic drug of innovative therapy /cell therapy drugmicrofat (5 ml) associated with PRP with a dose of 1 billion of platelets (5 ml) |
| Microfat | Experimental | Drug: Autologous biologic drug of innovative therapy /cell therapy drugmicrofat (5 ml) and saline solution (5 ml) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females between 20 to 65 years of age
- Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4 with VAS > 4 and failure of medical treatment for at least one year
- BMI between 20 to 30
- Written informed consent, signed by patient or legal representative
- HB > 10g/dl
Key exclusion criteria (20 listed)
- IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
- BMI < 20
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- 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 |
|---|---|---|
| Autologous biologic drug of innovative therapy /cell therapy drugArticular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution | Drug | Microfat, Microfat + PRP 1M platelets, Microfat + PRP 3M platelets |
Primary outcome
Cartilage relaxation time on MRI T2-mapping at 3 months
Time frame: Baseline and 3 months post injection
The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months.
5 secondary outcomes
Improved of chondral lesion on MRI
Time frame: Baseline and 3 and 6 months post injection
Pain
Time frame: Baseline and 1 and 3 and 6 months post injection
Responding patients
Time frame: Baseline and 3 and 6 months post injection
Biologic parameters / clinical efficacity
Time frame: Baseline and 3 and 6 months post injection
WOMAC
Time frame: Baseline and 1 and 3 and 6 months post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 33887408Louis ML, Dumonceau RG, Jouve E, Cohen M, Djouri R, Richardet N, Jourdan E, Giraudo L, Dumoulin C, Grimaud F, George FD, Veran J, Sabatier F, Magalon J. Intra-Articular Injection of Autologous Microfat and Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Comparative Study. Arthroscopy. 2021 Oct;37(10):3125-3137.e3. doi: 10.1016/j.arthro.2021.03.074. Epub 2021 Apr 20.
- Individual participant dataSharing planned: No. Publication
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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.
Marie Laure Louis, MD principal investigator
ICOS Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous biologic drug of innovative therapy /cell therapy drug in people with Knee Osteoarthritis, run by Clinique Juge 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 20 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: finished, as of the sponsor's last update on 20 Apr 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage relaxation time on MRI T2-mapping at 3 months (time frame: Baseline and 3 months post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352075, which also lists 1 linked publication.
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 20 Apr 2020.