A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis (ADIPOA-2)

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ClinicalTrials.gov Identifier: NCT02838069

Recruitment Status : Unknown

Verified November 2016 by University Hospital, Montpellier.
Recruitment status was: Recruiting

First Posted : July 20, 2016

Last Update Posted : November 8, 2016

Sponsor:

Collaborators:

University Hospital, Toulouse

Assistance Publique - Hôpitaux de Paris

NATIONAL UNIVERSITY OF IRELAND, GALWAY (NUIG)

ISTITUTO ORTOPEDICO RIZZOLI (IOR)

Etablissement Français du Sang

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

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN)

HUMAN MED AG (HM)

Stichting Katholieke Universiteit

SPORTS SURGERY CLINIC LIMITED

UNIVERSITA DEGLI STUDI DI PADOVA (UNIPD)

EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK)

PINTAIL LTD (PT)

Centre National de la Recherche Scientifique, France

UNIVERSITAET ULM (UULM)

Cambridge University Hospitals NHS Foundation Trust

Aries srl (ARIES)

Information provided by (Responsible Party):

University Hospital, Montpellier

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Biological: Injection (2x106 ASC/5ml). Biological: Injection (10x106 ASC/5ml). Other: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	153 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	September 2016
Estimated Primary Completion Date :	January 2019
Estimated Study Completion Date :	June 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Osteoarthritis

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2x106 ASC intra-articular injection 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 (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.
Experimental: 10x106 ASC intra-articular injection 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.	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.
Placebo Comparator: Placebo 0.5% glucose in saline with 4.5% albumin	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.

Outcome Measures

Primary Outcome Measures :

Improvement of pain or physical function [ Time Frame: 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 :

Disability [ Time Frame: Months 1, 3, 6, 12 and 24 ]
assessed by WOMAC questionnaire
Disability [ Time Frame: Months 1, 3, 6, 12 and 24 ]
assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)
Disability [ Time Frame: Months 1, 3, 6, 12 and 24 ]
assessed by SAS questionnaire (The Short Arthritis Assessment Scale)
Quality of life [ Time Frame: Months 1, 3, 6, 12 and 24 ]
assessed by SF-36 questionnaire
painkillers consumption [ Time Frame: Months 1, 3, 6, 12 and 24 ]
Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers
Structural changes [ Time Frame: 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 [ Time Frame: Months 12 and 24 ]
Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838069

Contacts

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Contact: Christian Jorgensen, MD, PhD	+33467337796	christian.jorgensen@inserm.fr
Contact: Yves-Marie Pers, MD	+33467337231	ym-pers@chu-montpellier.fr

Locations

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France
UH Montpellier	Recruiting
Montpellier, France, 34295
Contact: Christian Jorgensen, MD 0033 467 337798 christian.jorgensen@chu-montpellier.fr
Contact: Yves Marie PERS, MD rosanna.ferreira@chu-montpellier.fr
Principal Investigator: Christian Jorgensen, MD

Sponsors and Collaborators