OsteoarthritisPhase 1/2AMIPREPNCT03164122
EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA
A Phase 1/2 study testing injection of microfat and plasma rich platelet PRP and MRI in people with Osteoarthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Recently, the emergence of biotherapies has allowed the use of intra-articular injections of autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the demonstration that platelets-enriched plasma, by virtue of its growth factors concentration, stimulates in vitro and in vivo… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- injection of microfat and plasma rich platelet PRP and MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2017to 7 Jun 2018
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 20 and 75 years of age
- Symptomatic radio-carpal osteoarthritis diagnosed by arthroscanner resistant to medical treatment and candidate to surgery
- BMI ≥ 20 Kg/m²
- Written informed consent, signed by patient or legal representative (if patient unable to sign).
- HB > 10g/dl
- Negative pregnancy test and efficiency contraception
Who cannot join
- - Thrombocytopenia < 150 G/L, Thrombocytosis > 450 G/L, Thrombopathy
- TP < 70%, TCA patient / witness rapport > 1,20
- Anemia: 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, antivitamin K completed more than 2 weeks before inclusion
- Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
Show all 13Show fewer
- Intra articular injection of corticosteroid or hyaluronic acid completed more than 8 weeks before inclusion
- NSAI treatment completed more than 2 weeks before inclusion
- Fever or recent disease completed more than 1 month before inclusion
- Auto immune disease, Inflammatory or microcrystalline Arthritis, Immune deficit
- Infectious disease
- MRI contraindication: ocular loose bodies, pace maker, neurostimulator, cochlear implant, vascular clips, metallic cardiac val
- Anesthesia or surgery contra indication, iodine allergy
Trial locations and contacts
1 site in 1 country.
About this study
Recently, the emergence of biotherapies has allowed the use of intra-articular injections of autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the demonstration that platelets-enriched plasma, by virtue of its growth factors concentration, stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent literature highlights that these autologous products are very well tolerated by humans. PRP, as an intra-articular injection therapy, seems to be an autologous biological medicine, innovative for cartilage injury reparation and showing good primary results for this indication.
Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to differentiate into several cellular lines in vitro and in vivo, including cartilage cells.
Read more
The association of microfat and PRP is interesting in order to potentiate trophic and regenerative effects on damaged cartilage site. The combination of these two products, respectively rich in autologous multipotent stem cells and growth factors, aims to create an optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase is playing the role of a nutritive support matrix which contains and limits the diffusion and resorption of PRP liquid while allowing progressive growth factors release on the injection site.
The hypothesis of this project is that standardized injection of an innovative treatment (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative second line treatment in case of medical treatment failure.
Read the detailed description
Material and methods:
This research protocol aims to evaluate the safety of intra-articular injection of a mixture of autologous microfat associated with autologous PRP for radiocarpal osteoarthritis resistant to medical treatment.
This is a prospective, longitudinal, intrasubject, single-center clinical trial phase I-IIa evaluating the safety and feasibility of this innovative treatment.
Twelve patients will receive an intra-articular injection of 4 ml of an homogeneous mixture of autologous PRP (2ml) and microfat (2ml).
- Conditions
- Osteoarthritis
- Being tested
- injection of microfat and plasma rich platelet PRP, MRI
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of microfat and plasma rich platelet PRPDrug
intra-articular injections
MRIDevice
MRI 3T
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular injection | Experimental | Not described Receives: Drug: injection of microfat and plasma rich platelet PRP; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the safety
By the number of Adverse event related to the traitment
Measured: 1 MONTH
Secondary outcomes (4)
Improvement of pain
with the Visual Analogue Scale (VAS).
Measured: 3 ,6, 12 months
Improvement of wrist pain
with DASH scores
Measured: 3 ,6, 12 months
Improvement of wrist pain and function
with PWRE scores
Measured: 3, 6,12 months
Improvement of radiocarpal chondral lesions
MRI
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 posted23 May 2017
- Study start22 May 2017
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
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 OsteoarthritisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-olivier ARNAUD, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164122
- Sponsor's protocol ID
- 2016-34
- Other IDs
- 2016-002648-18, 2016
- Acronym
- AMIPREP
- Status last verified
- Mar 2019
- First submitted
- 19 May 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mayoly A, Witters M, Jouve E, Bec C, Iniesta A, Kachouh N, Veran J, Grimaud F, Zavarro AC, Fernandez R, Bendahan D, Giraudo L, Dumoulin C, Chagnaud C, Casanova D, Sabatier F, Legre R, Jaloux C, Magalon J. Intra Articular Injection of Autologous Microfat and Platelets-Rich Plasma in the Treatment of Wrist Osteoarthritis: A Pilot Study. J Clin Med. 2022 Sep 29;11(19):5786. doi: 10.3390/jcm11195786.
PubMed 36233654
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA
- ClinicalTrials.gov ID
- NCT03164122
- Acronym / sponsor ID
- AMIPREP / 2016-34
- Conditions
- Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 23 May 2017 (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.
Recently, the emergence of biotherapies has allowed the use of intra-articular injections of autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the demonstration that platelets-enriched plasma, by virtue of its growth factors concentration, stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent literature highlights that these autologous products are very well tolerated by humans. PRP, as an intra-articular injection therapy, seems to be an autologous biological medicine, innovative for cartilage injury reparation and showing good primary results for this indication.
Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to differentiate into several cellular lines in vitro and in vivo, including cartilage cells.
The association of microfat and PRP is interesting in order to potentiate trophic and regenerative effects on damaged cartilage site. The combination of these two products, respectively rich in autologous multipotent stem cells and growth factors, aims to create an optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase is playing the role of a nutritive support matrix which contains and limits the diffusion and resorption of PRP liquid while allowing progressive growth factors release on the injection site.
The hypothesis of this project is that standardized injection of an innovative treatment (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative second line treatment in case of medical treatment failure.
Detailed description
Material and methods:
This research protocol aims to evaluate the safety of intra-articular injection of a mixture of autologous microfat associated with autologous PRP for radiocarpal osteoarthritis resistant to medical treatment.
This is a prospective, longitudinal, intrasubject, single-center clinical trial phase I-IIa evaluating the safety and feasibility of this innovative treatment.
Twelve patients will receive an intra-articular injection of 4 ml of an homogeneous mixture of autologous PRP (2ml) and microfat (2ml).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-articular injection | Experimental | Drug: injection of microfat and plasma rich platelet PRP, Device: MRI |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females between 20 and 75 years of age
- Symptomatic radio-carpal osteoarthritis diagnosed by arthroscanner resistant to medical treatment and candidate to surgery
- BMI ≥ 20 Kg/m²
- Written informed consent, signed by patient or legal representative (if patient unable to sign).
- HB > 10g/dl
Key exclusion criteria (13 listed)
- - Thrombocytopenia < 150 G/L, Thrombocytosis > 450 G/L, Thrombopathy
- TP < 70%, TCA patient / witness rapport > 1,20
- Anemia: 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, antivitamin K completed more than 2 weeks before inclusion
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 |
|---|---|---|
| injection of microfat and plasma rich platelet PRPintra-articular injections | Drug | Intra-articular injection |
| MRIMRI 3T | Device | Intra-articular injection |
Primary outcome
evaluate the safety
Time frame: 1 MONTH
By the number of Adverse event related to the traitment
4 secondary outcomes
Improvement of pain
Time frame: 3 ,6, 12 months
Improvement of wrist pain
Time frame: 3 ,6, 12 months
Improvement of wrist pain and function
Time frame: 3, 6,12 months
Improvement of radiocarpal chondral lesions
Time frame: 12 Months
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 8 May 2026.
- Results publication: PubMed 36233654Mayoly A, Witters M, Jouve E, Bec C, Iniesta A, Kachouh N, Veran J, Grimaud F, Zavarro AC, Fernandez R, Bendahan D, Giraudo L, Dumoulin C, Chagnaud C, Casanova D, Sabatier F, Legre R, Jaloux C, Magalon J. Intra Articular Injection of Autologous Microfat and Platelets-Rich Plasma in the Treatment of Wrist Osteoarthritis: A Pilot Study. J Clin Med. 2022 Sep 29;11(19):5786. doi: 10.3390/jcm11195786.
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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.
jean-olivier ARNAUD study director
Assistance Publique Hopitaux De Marseille
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 injection of microfat and plasma rich platelet PRP and MRI in people with Osteoarthritis, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 13 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 8 May 2026. 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?
evaluate the safety (time frame: 1 MONTH). 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 NCT03164122, 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 8 May 2026.