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

NCT06485843 | Recruiting Phase 2 FDA Drug

• 1 other identifier: OA-SYS-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Presence of Adverse Events

  Presence of adverse events in less than 5% of the study population, as a measure of safety

  52 weeks

Secondary Outcomes (3)

• Change in NSAIDs Use

  52 weeks

• Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  52 weeks

• Change in the Visual Analog Scale (VAS)

  52 weeks

Other Outcomes (2)

• Incidence of treatment-emergent adverse events (TEAEs)

  52 weeks

• Incidence of withdrawals due to adverse events (AEs)

  52 weeks

Study Arms (1)

OA-SYS

EXPERIMENTAL

Treatment with OA-SYS

Drug: OA-SYS

Interventions

OA-SYS DRUG

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

OA-SYS

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method till end of the study period and negative pregnancy test
• For males of reproductive potential: use of condoms and other methods to ensure effective contraception

You may not qualify if:

• Known or suspected infection of the target joint
• Subjects with surgery for OA in the target joint
• Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
• Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90 mmHg even with treatment with more than three antihypertensive drugs
• Subject with serious medical conditions other than cardiovascular disease
• Subject with, or with a medical history of autoimmune diseases
• Subject with an infection that requires parenteral antibiotic administration within 30 days prior to screening
• Subject with a medical history of mental disorder or epilepsy
• Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
• Subject who was diagnosed with cancer within 5 years before screening
• Subject who participated in another clinical trial within 6 months prior to the screening of this clinical trial
• Subject who was administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks prior to the screening
• Subject who had intra-articular administration such as sodium hyaluronate injections within 6 months prior to the screening
• Clinical findings consistent with active infection or crystal disease in the index joint within 1 month prior to the screening
• History of fracture in the index limb or fracture with sequelae within 12 months prior to the screening

Sponsors & Collaborators

• Ageless Biotech, Inc.: lead

Study Sites (1)

Orthopedic & Sports Medicine Institute of Las Vegas

Las Vegas, Nevada, 89117, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Vince Liguori

CONTACT

847-561-0217; vince@agebiomed.com

Mukesh Kumar, PhD RAC

CONTACT

2407504893; mkumar@fdamap.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 3, 2024
• Study Start: May 21, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)