Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03850080
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2019-02-20
Brief Title:
Autologous Conditioned Serum Functional and Clinical Results
Sponsor:
Ospedale San Raffaele
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Autologous Conditioned Serum Functional and Clinical Results Using a Novel Disease Modifying Agent for the Management of Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None