ADIPOA - Clinical Study

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: Autologous adipose derived stem cells administrated for intra-articular use
* Biological: Autologous adipose derived stem cells administrated for intra-articular use


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>2 x 10E6 ASC intra-articular injection (5 ml) | Biological: Autologous adipose derived stem cells administrated for intra-articular use<br>* 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.<br>|
| Experimental: Group 2<br>10 x 10E6 ASC intra-articular injection (5 ml) | Biological: Autologous adipose derived stem cells administrated for intra-articular use<br>* 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.<br>|
| Experimental: Group 3<br>50 x 10E6 ASC intra-articular injection (5 ml) | Biological: Autologous adipose derived stem cells administrated for intra-articular use<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of Serious Adverse Events | Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event. | during 365 days following injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status of the knee | 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. | during 365 days following injection | 
| Evaluation of Quality of life | 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. | during 365 days following injection |