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
Ageless Biotech, Inc.
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.
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 answe…
Eligibility
- Age range
- 35–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2 * Ambulatory and in good general health * Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions * Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment * Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee * No clinically significant abnormalities observed in medical history, physical exam vital signs, and laboratory assessments * For females of reproductive p…
Interventions
- DrugOA-SYS
OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.
Location
- Orthopedic & Sports Medicine Institute of Las VegasLas Vegas, Nevada