ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Study Overview
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Brief Summary
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This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.

Detailed Description
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This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.

Official Title
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Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Biological: ADSC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: voluntarily provided written Informed Consent ages 20-70 male or female grades I-III radiologically documented OA of one or both knees American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35 knee pain graded as greater than 3 out of 10 on screening questionnaire able to speak, read and understand English - Exclusion Criteria: patient parameters falling outside of the inclusion criteria current oral or parenteral steroid or blood thinner use hyaluronic acid-based injection to the affected knee joint within the previous six months corticosteroid injection to the affected knee joint within the previous three months end stage (Grade IV) OA

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Single injection of ADSC | Biological: ADSC<br>* Single injection of ADSC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Measured by Adverse Events | Adverse Events were recorded during the entirety of the study. | Entire Study (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment). WOMAC score: 0 (best) to 100 (worst) | Baseline to 1 year | 
| Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain | Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain). | Baseline to 1 year | 
| Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion | Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative. | Baseline to 3 months | 
| Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). | Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds. | baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADSC, osteoarthritis, knee, adipose