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Completed

NCT Number: NCT01585857

ADIPOA - Clinical Study

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).

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UH Montpellier, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous adipose derived stem cells administrated for intra-articular use

Biological

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.

Primary outcomes

  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 outcomes

  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. Evaluation of 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2012
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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