NCT06485843

An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Ageless Biotech, Inc. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Osteo Arthritis Knee

Interventions

Type	Name	Description
DRUG	OA-SYS	OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.

Timeline

• Start date: 2025-05-21
• Primary completion: 2028-03-31
• Completion: 2028-12-31
• First posted: 2024-07-03
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study