Autologous Conditioned Serum: Functional and Clinical Results

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the potential ability of autologous conditioned serum (ACS) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (OA).

Detailed Description
-----------------
Fifteen patients with clinical and radiological signs of OA of the hip or knee were recruited for this study. Each patient received 4 injections of ACS (Orthokine®) at the site of OA once per week for 4 weeks. Clinical and functional evaluation were performed using VAS scale for pain, WOMAC scale and KSS functional and clinical scores before the first injection, at one week, at two weeks, at three weeks, at one month and at six months. Statistical analysis was done with the Wilcoxon Signed-Rank Test.

Official Title
-----------------
Autologous Conditioned Serum: Functional and Clinical Results Using a Novel Disease Modifying Agent for the Management of Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis, Osteoarthritis, Knee, Cartilage Degeneration

Intervention / Treatment
-----------------
* Drug: Autologous Conditioned Serum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee osteoarthritis >3 months in clinical and radiographic signs VAS for pain >50mm Exclusion Criteria: Hepatitis B Hepatitis C HIV pregnancy drug abuse other intra-articular injections <6 months surgery on affected knee <12 months

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single cohort prospective interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Conditioned Serum<br>Patients that were deemed admissible to the trial received 1 intra-articular injection of autologous conditioned serum (Orthokine®) for 4 consecutive weeks at the site of OA. These patients were then followed at 1 month and 6 months for clinical and functional evaluation using VAS for pain, WOMAC, and KSS. | Drug: Autologous Conditioned Serum<br>* Fifteen patients with clinical and radiological signs of OA of the knee were recruited for this study. 50mL of whole blood were taken using a special syringe containing CrSO4-coated grade glass beads in order to promote IL-1ra synthesis and aggregation.The incubation period lasted 7 hours after which, the blood-filled syringes were centrifuged and the serum supernatant was filtered and aliquoted into four 3mL portions. The aliquots were stored at -20oC until their use was necessary. Patients received 1 intra-articular injection for 4 consecutive weeks at the site of OA.<br>* Other names: Orthokine®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) | 24 questions each scaled out of 100mm. 5 questions regarding pain. 2 questions regarding rigidity. 17 questions regarding difficulty in various activities. Total score out of 240 expressed as a percentage. Minimum score 0. Max score 100. Greater score implies worsening symptomatology. | 6 months | 
| Knee Society Score (KSS) | Clinical Score. Pain is measured out of 50 (no pain = 50, severe pain = 0). Range of motion (1 point for every 5 degress of flexion. Max points = 25). Stability; anteroposterior (<5 degrees 10, 5-10 degrees 5, >10 degrees 0); mediolateral (<5 degrees = 10, 5-10 degrees = 5, >10 degrees = 0); Flexion contracture (5-10 degrees = -2, 10-15 degrees = -5, 16-20 degrees = -10, >20 degrees = -15); Extension lag (<10 degrees = -5, 10-20 degrees = -10, 20 degrees = -15); Alignment (0-4 degrees = 0, 5-15 degrees = 3 points for each degree). Functional Score. Consists of walking score based on how many blocks (100m) patient can walk without stopping (unlimited = 100, >10 blocks = 40, 5-10 blocks = 30, <5 blocks = 20, housebound = 10, unable = 0); Stairs (normal = 50, normal up down with support = 40, up and down with support = 30, up with support down unable = 15, unable = 0); Functional deductions (cane = -5, two canes = -10, crutches or walker = -20) | 6 months | 
| Visual Analog Score for Pain | Subjective evaluation of pain reported by each patient on average since the last visit. Minimum = 0. Maximum = 10 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Osteoarthritis, Inflammation, Joint, Autologous Conditioned Serum