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

Summary

ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.

The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.

This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.

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.

Sponsors & Collaborators

• University Hospital, Toulouse

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• Istituto Ortopedico Rizzoli

  collaborator OTHER

• Etablissement Français du Sang

  collaborator OTHER

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

  collaborator OTHER_GOV

• European Clinical Research Infrastructure Network

  collaborator OTHER

• HUMAN MED AG (HM)

  collaborator UNKNOWN

• Stichting Katholieke Universiteit

  collaborator OTHER

• SPORTS SURGERY CLINIC LIMITED

  collaborator UNKNOWN

• University of Padova

  collaborator OTHER

• EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK)

  collaborator UNKNOWN

• PINTAIL LTD (PT)

  collaborator UNKNOWN

• Centre National de la Recherche Scientifique, France

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Aries srl (ARIES)

  collaborator UNKNOWN

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Christian Jorgensen, MD, PhD · University Hospital, Montpellier

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-20

Primary Completion

2022-09-30

Completion

2024-03-31

Countries

• France

Study Locations