EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA (AMIPREP)
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|ClinicalTrials.gov Identifier: NCT03164122|
Recruitment Status : Unknown
Verified June 2017 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : May 23, 2017
Last Update Posted : June 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: injection of microfat and plasma rich platelet PRP Device: MRI||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 22, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: Intra-articular injection||
Drug: injection of microfat and plasma rich platelet PRP
- evaluate the safety [ Time Frame: 1 MONTH ]By the number of Adverse event related to the traitment
- Improvement of pain [ Time Frame: 3 ,6, 12 months ]with the Visual Analogue Scale (VAS).
- Improvement of wrist pain [ Time Frame: 3 ,6, 12 months ]with DASH scores
- Improvement of wrist pain and function [ Time Frame: 3, 6,12 months ]with PWRE scores
- Improvement of radiocarpal chondral lesions [ Time Frame: 12 Months ]MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164122
|Contact: Regis LEGREfirstname.lastname@example.org|
|Assisatnce Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Study Director:||jean-olivier ARNAUD||Assistance Publique Hopitaux De Marseille|