Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485843
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-17
Brief Title:
An Open Label Phase IIb Study to Evaluate Safety and Tolerability of OA-SYS in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
Sponsor:
Ageless Biomed Inc
Organization:
Ageless Biomed Inc
Study Overview
Official Title:
An Open Label Phase IIb Study to Evaluate Safety and Tolerability of OA-SYS in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OA-SYS-01
Brief Summary:
This study is being conducted to evaluate the safety and tolerability of OA-SYS in patients with moderate to severe OA of the knee joint
Detailed Description:
PURPOSE OF THE STUDY The goal of this clinical trial is to evaluate the safety and tolerability of a treatment called OA-SYS for moderate to severe osteoarthritis OA of the knee Osteoarthritis is a common condition that affects the joints and can cause significant pain and disability especially in older adults The study aims to see if OA-SYS is a safe and effective treatment option for people with knee osteoarthritis
STUDY TREATMENT
Participants in this study will receive the OA-SYS treatment which involves the use of adult stem cells ASCs The main questions the study aims to answer are
Is OA-SYS safe and well-tolerated by participants with moderate to severe knee osteoarthritis
Does OA-SYS help reduce the symptoms and improve the function of the knee joint
Participants will
Receive the OA-SYS treatment which includes adult stem cells administered to the knee joint
Attend regular clinic visits for check-ups and monitoring
Report any side effects or changes in their condition throughout the study period
RANDOMIZATION AND BLINDING This is a phase II open-label clinical trial blinding is not applicable to this study
STUDY TREATMENT
Participants in this study will receive the OA-SYS treatment which involves the use of adult stem cells ASCs The main questions the study aims to answer are
Is OA-SYS safe and well-tolerated by participants with moderate to severe knee osteoarthritis
Does OA-SYS help reduce the symptoms and improve the function of the knee joint
Participants will
Receive the OA-SYS treatment which includes adult stem cells administered to the knee joint
Attend regular clinic visits for check-ups and monitoring
Report any side effects or changes in their condition throughout the study period
RANDOMIZATION AND BLINDING This is a phase II open-label clinical trial blinding is not applicable to this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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