Clinical trial NCT02838069: A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
Official title: A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Toulouse
name: Assistance Publique - Hôpitaux de Paris
name: National University of Ireland, Galway, Ireland
name: Istituto Ortopedico Rizzoli
name: Etablissement Français du Sang
name: Institut National de la Santé Et de la Recherche Médicale, France
name: European Clinical Research Infrastructure Network
name: HUMAN MED AG (HM)
name: Stichting Katholieke Universiteit
name: SPORTS SURGERY CLINIC LIMITED
name: University of Padova
name: EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK)
name: PINTAIL LTD (PT)
name: Centre National de la Recherche Scientifique, France
name: University of Ulm
name: Cambridge University Hospitals NHS Foundation Trust
name: Aries srl (ARIES)
First posted: 2016-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR)
* Must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month
* NSAID washout of at least 2 days before screening/baseline

Exclusion Criteria:

* Previous treatments acting on cartilage or bone metabolism
* Received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months,
* Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening.
* Kellgren-Lawrence Grade 1 or 4 in the index knee on any incidences.
* Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned
* History of joint replacement of the knee or hip within the previous 12 months

Primary outcomes:
measure: Improvement of pain or physical function
timeFrame: Month 6
Secondary outcomes:
measure: Disability (WOMAC)
timeFrame: Months 1, 3, 6, 12 and 24
measure: Disability (KOOS)
timeFrame: Months 1, 3, 6, 12 and 24
measure: Disability (SAS)
timeFrame: Months 1, 3, 6, 12 and 24
measure: Change in Quality of life
timeFrame: Months 1, 3, 6, 12 and 24
measure: painkillers consumption
timeFrame: Months 1, 3, 6, 12 and 24
measure: Structural changes (X-Ray)
timeFrame: Months 12 and 24
measure: Structural changes (MRI)
timeFrame: Months 12 and 24
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Christian Jorgensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: