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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: injection of microfat and plasma rich platelet PRP Device: MRI Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Intra-articular injection Drug: injection of microfat and plasma rich platelet PRP
intra-articular injections

Device: MRI
MRI 3T




Primary Outcome Measures :
  1. evaluate the safety [ Time Frame: 1 MONTH ]
    By the number of Adverse event related to the traitment


Secondary Outcome Measures :
  1. Improvement of pain [ Time Frame: 3 ,6, 12 months ]
    with the Visual Analogue Scale (VAS).

  2. Improvement of wrist pain [ Time Frame: 3 ,6, 12 months ]
    with DASH scores

  3. Improvement of wrist pain and function [ Time Frame: 3, 6,12 months ]
    with PWRE scores

  4. Improvement of radiocarpal chondral lesions [ Time Frame: 12 Months ]
    MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Regis LEGRE 0413429272 regis.legre@ap-hm.fr
Contact: DRCI 0491382747 drci@ap-hm.fr

Locations
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France
Assisatnce Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03164122     History of Changes
Other Study ID Numbers: 2016-34
2016-002648-18 ( EudraCT Number )
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases