NCT03164122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2018

Completed
Last Updated

May 8, 2026

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

May 19, 2017

Last Update Submit

May 4, 2026

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • evaluate the safety

    By the number of Adverse event related to the traitment

    1 MONTH

Secondary Outcomes (4)

  • Improvement of pain

    3 ,6, 12 months

  • Improvement of wrist pain

    3 ,6, 12 months

  • Improvement of wrist pain and function

    3, 6,12 months

  • Improvement of radiocarpal chondral lesions

    12 Months

Study Arms (1)

Intra-articular injection

EXPERIMENTAL
Drug: injection of microfat and plasma rich platelet PRPDevice: MRI

Interventions

injection of microfat and plasma rich platelet PRPDRUG

intra-articular injections

Intra-articular injection
MRIDEVICE

MRI 3T

Intra-articular injection

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisatnce Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • 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.

    PMID: 36233654RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • jean-olivier ARNAUD

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 23, 2017

Study Start

May 22, 2017

Primary Completion

June 7, 2018

Study Completion

June 7, 2018

Last Updated

May 8, 2026

Record last verified: 2019-03

Locations

FR(1)