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

NCT ID: NCT03164122

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2018-06-07

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-articular injection

Group Type: EXPERIMENTAL

injection of microfat and plasma rich platelet PRP

Intervention Type: DRUG

intra-articular injections

MRI

Intervention Type: DEVICE

MRI 3T

Interventions

injection of microfat and plasma rich platelet PRP

intra-articular injections

Intervention Type: DRUG

MRI

MRI 3T

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean-olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assisatnce Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2016-002648-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2016-34

Identifier Type: -

Identifier Source: org_study_id