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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
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.
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.
Age
35 - 75 years
Sex
ALL
Healthy Volunteers
No
Orthopedic & Sports Medicine Institute of Las Vegas
Las Vegas, Nevada, United States
Start Date
May 21, 2025
Primary Completion Date
March 31, 2028
Completion Date
December 31, 2028
Last Updated
September 18, 2025
400
ESTIMATED participants
OA-SYS
DRUG
Lead Sponsor
Ageless Biotech, Inc.
NCT07153471
NCT07351968
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06747494