Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431152
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-17
Brief Title:
Intra-articular Injection of UC-MSC Exosome in Knee Osteoarthritis
Sponsor:
Universidad de los Andes Chile
Organization:
Universidad de los Andes Chile
Study Overview
Official Title:
Administration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee Safety Determination in a Pilot Dose-escalation Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
EXO-OA01
Brief Summary:
The study aim to evaluate safety of exosomes sEVs from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis The sEVs will be produced in a GMP-facility The investigators expect to enroll 12 patients in this phase 1 trial open label dose-escalation pilot and the follow-up will be up to 12 months
Detailed Description:
The clinical investigation will represent a Phase 1 trial focusing on small extracellular vesicles derived from mesenchymal stem cell MSC-sEV in patients with symptomatic Kellgren II-III knee OA The phase 1 component of the study will be an open-label dose escalation pilot study in which three cohorts of subjects with OA will receive increasing doses of UC-MSC-sEV administered as a single intra-articular IA injection Each cohort will comprise four participants Eligible study subjects will be enrolled at the Clinica Universidad de los Andes
The small extracellular vesicles derived from umbilical cord mesenchymal stem cell UC-MSC-sEV will be prepared in the Clinica Universidad de los Andes GMP facility The sEV-based therapeutic for clinical use will be manufactured in compliance with standardized procedures based on Good Manufacture Practice GMP regulations and all quality controls aforementioned The sEV therapeutic will be transported to the patient administration site under controlled conditions ensuring maintenance of a temperature range between 2-8C The sEV injection is expected to be administered within the first 6 h of product manufacture
The primary study endpoints of this trial will focus on the safety feasibility and toxicity of the sEV-based product The phase I will examine 1 the incidence of immediate post-infiltration adverse reactions in patients 2 the occurrence of synovitis post-infiltration in patients at 24 and 48 hours as well as on days 7 and 15 3 the frequency of post-infiltration pain reported by patients at 24 and 48 h and on days 7 and 15 and 4 the prevalence of adverse events related to sEV therapy occurring beyond IA infiltration at 24 and 48 h and on days 7 and 15 as well as at months 2 4 6 8 10 and 12 The secondary study endpoint will be determine the optimal dose for phase II trials The criteria that will be considered are 1 Safety profile at infiltration at 24 and 48 h and on days 7 and 15 as well as at months 2 4 6 8 10 and 12 2 changes in WOMAC scores at months 2 4 6 8 10 and 12 and 3 alterations in the Visual Analog Scale VAS pain scores at months 2 4 6 8 10 and 12
The small extracellular vesicles derived from umbilical cord mesenchymal stem cell UC-MSC-sEV will be prepared in the Clinica Universidad de los Andes GMP facility The sEV-based therapeutic for clinical use will be manufactured in compliance with standardized procedures based on Good Manufacture Practice GMP regulations and all quality controls aforementioned The sEV therapeutic will be transported to the patient administration site under controlled conditions ensuring maintenance of a temperature range between 2-8C The sEV injection is expected to be administered within the first 6 h of product manufacture
The primary study endpoints of this trial will focus on the safety feasibility and toxicity of the sEV-based product The phase I will examine 1 the incidence of immediate post-infiltration adverse reactions in patients 2 the occurrence of synovitis post-infiltration in patients at 24 and 48 hours as well as on days 7 and 15 3 the frequency of post-infiltration pain reported by patients at 24 and 48 h and on days 7 and 15 and 4 the prevalence of adverse events related to sEV therapy occurring beyond IA infiltration at 24 and 48 h and on days 7 and 15 as well as at months 2 4 6 8 10 and 12 The secondary study endpoint will be determine the optimal dose for phase II trials The criteria that will be considered are 1 Safety profile at infiltration at 24 and 48 h and on days 7 and 15 as well as at months 2 4 6 8 10 and 12 2 changes in WOMAC scores at months 2 4 6 8 10 and 12 and 3 alterations in the Visual Analog Scale VAS pain scores at months 2 4 6 8 10 and 12
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