Health TrialsbyHealthPanel

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

ConditionsOsteoarthritisOsteo Arthritis Knee
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age35-75
SponsorAgeless Biotech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • OA-SYS

    Drug

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: OA-SYSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Presence of Adverse Events

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

Time frame
52 weeks

Secondary outcomes

1

Change in NSAIDs Use

Change in NSAIDS use, until study completion

Time frame
52 weeks
2

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

The WOMAC score is used in clinical trials to measure the condition of patients with osteoarthritis. It's a patient-reported outcome measure where 0 represents the worst possible score and 100 represents the best possible score. A higher score indicates worse pain, stiffness, and functional limitations.

Time frame
52 weeks
3

Change in the Visual Analog Scale (VAS)

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". A lower scale indicates better progress, which indicates less pain.

Time frame
52 weeks

Other outcomes

1

Incidence of treatment-emergent adverse events (TEAEs)

TEAEs are defined as adverse events with an onset on or after the time of first administration of the treatment.

Time frame
52 weeks
2

Incidence of withdrawals due to adverse events (AEs)

Reported withdrawals from the study due to adverse events, as a measure of safety.

Time frame
52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ageless Biotech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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