CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
Autologous Conditioned Serumdrug
Likely dose
Autologous Conditioned Serum 50mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03850080
NCT03850080Phase 3Completed

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

Ospedale San Raffaele·interventional·Posted Feb 21, 2019·Updated Feb 22, 2019

In Brief

A Phase 3 clinical trial evaluating Autologous Conditioned Serum for Knee Osteoarthritis and 2 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartOct 6, 2017
Primary CompletionSep 28, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.4 years ago

Interventions

Autologous Conditioned Serumdrug

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.