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

Primary Purpose

Osteoarthritis

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Injection (2x106 ASC/5ml).
Injection (10x106 ASC/5ml).
Placebo
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Montpellier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

2x106 ASC intra-articular injection

10x106 ASC intra-articular injection

Placebo

Arm Description

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 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.

0.5% glucose in saline with 4.5% albumin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2016
Last Updated
August 11, 2023
Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Toulouse, Assistance Publique - Hôpitaux de Paris, National University of Ireland, Galway, Ireland, Istituto Ortopedico Rizzoli, Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France, European Clinical Research Infrastructure Network, HUMAN MED AG (HM), Stichting Katholieke Universiteit, SPORTS SURGERY CLINIC LIMITED, University of Padova, EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK), PINTAIL LTD (PT), Centre National de la Recherche Scientifique, France, University of Ulm, Cambridge University Hospitals NHS Foundation Trust, Aries srl (ARIES)
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1. Study Identification

Unique Protocol Identification Number
NCT02838069
Brief Title
A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2x106 ASC intra-articular injection
Arm Type
Experimental
Arm Description
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.
Arm Title
10x106 ASC intra-articular injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.5% glucose in saline with 4.5% albumin
Intervention Type
Biological
Intervention Name(s)
Injection (2x106 ASC/5ml).
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Injection (10x106 ASC/5ml).
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of pain or physical function
Description
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
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Disability (WOMAC)
Description
assessed by WOMAC questionnaire
Time Frame
Months 1, 3, 6, 12 and 24
Title
Disability (KOOS)
Description
assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)
Time Frame
Months 1, 3, 6, 12 and 24
Title
Disability (SAS)
Description
assessed by SAS questionnaire (The Short Arthritis Assessment Scale)
Time Frame
Months 1, 3, 6, 12 and 24
Title
Change in Quality of life
Description
assessed by SF-36 questionnaire
Time Frame
Months 1, 3, 6, 12 and 24
Title
painkillers consumption
Description
Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers
Time Frame
Months 1, 3, 6, 12 and 24
Title
Structural changes (X-Ray)
Description
Changes from baseline (Day 0) to months 12 and 24 in femorotibial joint space of the index knee on X-ray
Time Frame
Months 12 and 24
Title
Structural changes (MRI)
Description
Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)
Time Frame
Months 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Jorgensen, MD, PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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