Autologous Conditioned Serum: Functional and Clinical Results

Phase 2

Completed

• Conditions: Knee Osteoarthritis; Osteoarthritis, Knee; Cartilage Degeneration
• Interventions: Drug: Autologous Conditioned Serum

• Registration Number: NCT03850080
• Lead Sponsor: Ospedale San Raffaele

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.

Study Timeline

• Study Start: 2017-10-06
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Conditioned Serum	Autologous Conditioned Serum	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.

Primary Outcome Measures

Name	Time	Method
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)	6 months	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.
Knee Society Score (KSS)	6 months	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)
Visual Analog Score for Pain	6 months	Subjective evaluation of pain reported by each patient on average since the last visit. Minimum = 0. Maximum = 10

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milan, Italy