NCT03850080

Autologous Conditioned Serum: Functional and Clinical Results

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Osteoarthritis, Knee
• Cartilage Degeneration

Interventions

Type	Name	Description
DRUG	Autologous Conditioned Serum	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.

Timeline

• Start date: 2017-10-06
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2019-02-21
• Last updated: 2019-02-22

Locations

1 site across 1 country: Italy