A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 20, 2016

Primary Completion Date

September 30, 2022

Study Completion Date

March 31, 2024

Conditions
Osteoarthritis
Interventions
BIOLOGICAL

Injection (2x106 ASC/5ml).

Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.

BIOLOGICAL

Injection (10x106 ASC/5ml).

Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.

OTHER

Placebo

Injection of placebo 0.5% glucose in saline with 4.5% alb/5ml The patient of this group will receive one single administration and will be followed for 12 months. A final follow up visit will occur at Month 24.

Trial Locations (1)

34295

UH Montpellier, Montpellier

All Listed Sponsors
collaborator

University Hospital, Toulouse

OTHER

collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

collaborator

National University of Ireland, Galway, Ireland

OTHER

collaborator

Istituto Ortopedico Rizzoli

OTHER

collaborator

Etablissement Français du Sang

OTHER

collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

collaborator

European Clinical Research Infrastructure Network

OTHER

collaborator

HUMAN MED AG (HM)

UNKNOWN

collaborator

Stichting Katholieke Universiteit

OTHER

collaborator

SPORTS SURGERY CLINIC LIMITED

UNKNOWN

collaborator

University of Padova

OTHER

collaborator

EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK)

UNKNOWN

collaborator

PINTAIL LTD (PT)

UNKNOWN

collaborator

Centre National de la Recherche Scientifique, France

OTHER

collaborator

University of Ulm

OTHER

collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

collaborator

Aries srl (ARIES)

UNKNOWN

lead

University Hospital, Montpellier

OTHER

NCT02838069 - A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis | Biotech Hunter | Biotech Hunter