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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)

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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

Tracking Information
First Submitted Date  ICMJE June 13, 2016
First Posted Date  ICMJE July 20, 2016
Last Update Posted Date November 8, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02838069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Injection (2x106 ASC/5ml).
  • 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.
    Intervention: Biological: Injection (10x106 ASC/5ml).
  • Placebo Comparator: Placebo
    0.5% glucose in saline with 4.5% albumin
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 15, 2016)
153
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02838069
Other Study ID Numbers  ICMJE UF 9494
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE
  • 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)
Investigators  ICMJE
Principal Investigator: Christian Jorgensen, MD, PhD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP