Autologous Conditioned Serum: Functional and Clinical Results

Last updated: February 21, 2019
Sponsor: Ospedale San Raffaele
Overall Status: Completed

Phase

2/3

Condition

Osteoarthritis

Cartilage Injuries

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT03850080
1ACS
  • Ages > 35
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • knee osteoarthritis >3 months in clinical and radiographic signs

  • VAS for pain >50mm

Exclusion

Exclusion Criteria:

  • Hepatitis B

  • Hepatitis C

  • HIV

  • pregnancy

  • drug abuse

  • other intra-articular injections <6 months

  • surgery on affected knee <12 months

Study Design

Total Participants: 15
Study Start date:
October 06, 2017
Estimated Completion Date:
September 28, 2018

Study 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.

Connect with a study center

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Site Not Available

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