CompletedPhase 1/2

EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA

France12 participantsStarted 2017-05-22

Plain-language 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 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.

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * \- 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

evaluate the safety

Timeframe: 1 MONTH

Trial details

NCT IDNCT03164122

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-07

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