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OA-SYS for Osteoarthritis (OA-SYS-01 Trial)

Phase 2
Recruiting
Research Sponsored by Ageless Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults between the ages of 35 - 75 years with a Body Mass Index (BMI) less than 39 kg/m2
Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee
Must not have
Known or suspected infection of the target joint
Subjects with surgery for OA in the target joint
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Summary

"This trial is testing the safety and how well patients can tolerate using OA-SYS for those with moderate to severe osteoarthritis in the knee joint."

Who is the study for?
This trial is for individuals with moderate to severe osteoarthritis of the knee. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a specific level of disease severity.
What is being tested?
The study is testing OA-SYS, which is likely a new treatment or intervention for knee osteoarthritis. The main goal is to see how safe it is and how well patients can tolerate it.
What are the potential side effects?
Since this trial aims to assess safety and tolerability, potential side effects are being investigated but are not listed here. Common side effects in such trials might include pain at the site of treatment, swelling, stiffness, or other joint-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 35 and 75 years old with a BMI under 39.
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My knee arthritis is severe, as per a doctor's grading.
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My recent health checks and lab tests show no significant issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I suspect or know I have an infection in the joint being treated.
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I have had surgery for osteoarthritis in the joint being studied.
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I have not needed IV antibiotics in the last 30 days.
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I have not had surgery on the joint in question in the last year.
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I do not have any serious life-threatening conditions.
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I have or have had an autoimmune disease.
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I am scheduled for or might need joint surgery during the study.
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I have a type of arthritis linked to an immune condition.
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I have severe heart issues or uncontrolled high blood pressure despite taking more than three blood pressure medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Presence of Adverse Events
Secondary study objectives
Change in NSAIDs Use
Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Change in the Visual Analog Scale (VAS)
Other study objectives
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of withdrawals due to adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: OA-SYSExperimental Treatment1 Intervention
Treatment with OA-SYS

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Who is running the clinical trial?

Ageless Biotech, Inc.Lead Sponsor
~267 spots leftby Mar 2028
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