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

Phase 2

Active, not recruiting

• Conditions: Osteoarthritis
• Interventions: Other: Placebo; Biological: Injection (10x106 ASC/5ml).; Biological: Injection (2x106 ASC/5ml).

• Registration Number: NCT02838069
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Study Start: 2016-09-20
• Primary Completion: 2022-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-16
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.5% glucose in saline with 4.5% albumin
10x106 ASC intra-articular injection	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.
2x106 ASC intra-articular injection	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.

Primary Outcome Measures

Name	Time	Method
Improvement of pain or physical function	Month 6	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

Secondary Outcome Measures

Name	Time	Method
painkillers consumption	Months 1, 3, 6, 12 and 24	Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers
Disability (KOOS)	Months 1, 3, 6, 12 and 24	assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)
Disability (WOMAC)	Months 1, 3, 6, 12 and 24	assessed by WOMAC questionnaire
Disability (SAS)	Months 1, 3, 6, 12 and 24	assessed by SAS questionnaire (The Short Arthritis Assessment Scale)
Change in Quality of life	Months 1, 3, 6, 12 and 24	assessed by SF-36 questionnaire
Structural changes (X-Ray)	Months 12 and 24	Changes from baseline (Day 0) to months 12 and 24 in femorotibial joint space of the index knee on X-ray
Structural changes (MRI)	Months 12 and 24	Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France