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ADIPOA - Clinical Study

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ClinicalTrials.gov Identifier: NCT01585857
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:

Primary:

To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

Secondary:

To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).


Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Autologous adipose derived stem cells administrated for intra-articular use Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint
Study Start Date : April 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
2 x 10E6 ASC intra-articular injection (5 ml)
 Biological: Autologous adipose derived stem cells administrated for intra-articular use
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.
Experimental: Group 2
10 x 10E6 ASC intra-articular injection (5 ml)
 Biological: Autologous adipose derived stem cells administrated for intra-articular use
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.
Experimental: Group 3
50 x 10E6 ASC intra-articular injection (5 ml)
 Biological: Autologous adipose derived stem cells administrated for intra-articular use
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.


Outcome Measures
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Primary Outcome Measures :
  1. Recording of Serious Adverse Events [ Time Frame: during 365 days following injection ]
    Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.


Secondary Outcome Measures :
  1. Functional status of the knee [ Time Frame: during 365 days following injection ]

    Efficacy will be assessed by measuring:

    • WOMAC (Western Ontario and McMaster Universities osteoarthritis index),
    • Short Arthritis assessment Scale (SAS),
    • range of motion of the target knee joint,
    • imaging through MRI evaluation, dGEMRIC and T1rho MRI.

  2. Quality of life [ Time Frame: during 365 days following injection ]

    Quality of life will be assessed by measuring:

    • pain-specific assessment
    • global patient assessment (visual analog scale, Short-Form 8)
    • decrease in rescue paracetamol medication.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.

Exclusion Criteria:

  • Any disease or medication affecting the bone or cartilage metabolism, including corticoids.
Contacts and Locations
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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): NCT01585857


Locations
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France
UH Montpellier
Montpellier, France, 34295
Germany
Orthopädische Klinik
Würzburg, Germany, 97074
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Christian Jorgensen, MD University Hospital, Montpellier
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01585857    
Other Study ID Numbers: 8606
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases