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

Osteoarthritis Clinical Trial

— ADIPOA-2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02838069
• Other study ID #: UF 9494
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 20, 2016
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (18)

Lead Sponsor

Collaborator

University Hospital, Montpellier

Aries srl (ARIES), Assistance Publique - Hôpitaux de Paris, Cambridge University Hospitals NHS Foundation Trust, Centre National de la Recherche Scientifique, France, Etablissement Français du Sang, European Clinical Research Infrastructure Network, EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK), HUMAN MED AG (HM), Institut National de la Santé Et de la Recherche Médicale, France, Istituto Ortopedico Rizzoli, National University of Ireland, Galway, Ireland, PINTAIL LTD (PT), SPORTS SURGERY CLINIC LIMITED, Stichting Katholieke Universiteit, University Hospital, Toulouse, University of Padova, University of Ulm

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of pain or physical function	evaluate the efficacy of ASC in mild to moderate knee OA (KL 2-3) based on increase in the number of "strict" responders defined by improvements from baseline in WOMAC pain or physical function subscores 50% with absolute changes 20 mm at 6 month, compared to placebo	Month 6
Secondary	Disability (WOMAC)	assessed by WOMAC questionnaire	Months 1, 3, 6, 12 and 24
Secondary	Disability (KOOS)	assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)	Months 1, 3, 6, 12 and 24
Secondary	Disability (SAS)	assessed by SAS questionnaire (The Short Arthritis Assessment Scale)	Months 1, 3, 6, 12 and 24
Secondary	Change in Quality of life	assessed by SF-36 questionnaire	Months 1, 3, 6, 12 and 24
Secondary	painkillers consumption	Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers	Months 1, 3, 6, 12 and 24
Secondary	Structural changes (X-Ray)	Changes from baseline (Day 0) to months 12 and 24 in femorotibial joint space of the index knee on X-ray	Months 12 and 24
Secondary	Structural changes (MRI)	Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)	Months 12 and 24