NCT04352075

Brief Summary

The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Nov 2018

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

Study Start

First participant enrolled

November 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 15, 2020

Last Update Submit

April 17, 2020

Conditions

Knee Osteoarthritis

Keywords

kneeosteoarthritismicrofatplatelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • Cartilage relaxation time on MRI T2-mapping at 3 months

    The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months.

    Baseline and 3 months post injection

Secondary Outcomes (5)

  • Improved of chondral lesion on MRI

    Baseline and 3 and 6 months post injection

  • Pain

    Baseline and 1 and 3 and 6 months post injection

  • Responding patients

    Baseline and 3 and 6 months post injection

  • Biologic parameters / clinical efficacity

    Baseline and 3 and 6 months post injection

  • WOMAC

    Baseline and 1 and 3 and 6 months post injection

Study Arms (3)

Microfat + PRP 3M platelets

EXPERIMENTAL

microfat (5 ml) associated with PRP with a dose of 3 billions of platelets (5 ml)

Drug: Autologous biologic drug of innovative therapy /cell therapy drug

Microfat + PRP 1M platelets

EXPERIMENTAL

microfat (5 ml) associated with PRP with a dose of 1 billion of platelets (5 ml)

Drug: Autologous biologic drug of innovative therapy /cell therapy drug

Microfat

EXPERIMENTAL

microfat (5 ml) and saline solution (5 ml)

Drug: Autologous biologic drug of innovative therapy /cell therapy drug

Interventions

Autologous biologic drug of innovative therapy /cell therapy drugDRUG

Articular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution

MicrofatMicrofat + PRP 1M plateletsMicrofat + PRP 3M platelets

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 20 to 65 years of age
  • Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4 with VAS \> 4 and failure of medical treatment for at least one year
  • BMI between 20 to 30
  • Written informed consent, signed by patient or legal representative
  • HB \> 10g/dl
  • Negative pregnancy test
  • Social security affiliated

You may not qualify if:

  • IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
  • BMI \< 20
  • Thrombocytopenia \< 150 G/L
  • Thrombocytosis \> 450 G/L
  • Thrombopathy
  • TP \< 70%
  • TCA patient / witness rapport \> 1,20
  • Anaemia: HB \< 10g/dl
  • Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
  • Fever or recent disease
  • Auto immune disease
  • Inflammatory Arthritis
  • Immune deficit
  • Infectious disease
  • Malignant tumor being treated or history of malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis

Marseille, 13008, France

Location

Related Publications (1)

  • Louis ML, Dumonceau RG, Jouve E, Cohen M, Djouri R, Richardet N, Jourdan E, Giraudo L, Dumoulin C, Grimaud F, George FD, Veran J, Sabatier F, Magalon J. Intra-Articular Injection of Autologous Microfat and Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Comparative Study. Arthroscopy. 2021 Oct;37(10):3125-3137.e3. doi: 10.1016/j.arthro.2021.03.074. Epub 2021 Apr 20.

    PMID: 33887408DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Marie Laure Louis, MD

    ICOS Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, monocentric randomised, double blind
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

November 15, 2018

Primary Completion

August 1, 2019

Study Completion

March 1, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Publication

Locations

FR(1)