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Autologous Conditioned Serum: Functional and Clinical Results

Primary Purpose

Knee Osteoarthritis, Osteoarthritis, Knee, Cartilage Degeneration

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Autologous Conditioned Serum
Sponsored by
Ospedale San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, Inflammation, Joint, Autologous Conditioned Serum

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale San Raffaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Conditioned Serum

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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)
Visual Analog Score for Pain
Subjective evaluation of pain reported by each patient on average since the last visit. Minimum = 0. Maximum = 10

Secondary Outcome Measures

Full Information

First Posted
February 20, 2019
Last Updated
February 21, 2019
Sponsor
Ospedale San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03850080
Brief Title
Autologous Conditioned Serum: Functional and Clinical Results
Official Title
Autologous Conditioned Serum: Functional and Clinical Results Using a Novel Disease Modifying Agent for the Management of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Osteoarthritis, Knee, Cartilage Degeneration
Keywords
Knee, Osteoarthritis, Inflammation, Joint, Autologous Conditioned Serum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Single cohort prospective interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Conditioned Serum
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Autologous Conditioned Serum
Other Intervention Name(s)
ACS, Orthokine®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
6 months
Title
Knee Society Score (KSS)
Description
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)
Time Frame
6 months
Title
Visual Analog Score for Pain
Description
Subjective evaluation of pain reported by each patient on average since the last visit. Minimum = 0. Maximum = 10
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Vitali, MD
Organizational Affiliation
Ospedale San Raffaele
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Autologous Conditioned Serum: Functional and Clinical Results

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