Evaluating OA-SYS for knee osteoarthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and tolerability of a treatment called OA-SYS, which utilizes adult stem cells, in patients suffering from moderate to severe osteoarthritis of the knee. Participants will receive the OA-SYS treatment directly into the knee joint and will be monitored for any side effects and improvements in knee function. The study is designed to determine if OA-SYS can effectively alleviate symptoms associated with knee osteoarthritis. Regular clinic visits will be conducted to ensure participant safety and adherence to the study protocol.

Why it matters

Who can join: the full rules

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 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

Exclusion Criteria:

* 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
* Joint instability or history of acute dislocation within 12 months prior to the screening
* Planned or anticipated surgery of the joint during the study period
* Presence of surgical hardware or other foreign body in the index joint
* Surgery or arthroscopy of the index joint within 12 months of screening
* Intra-articular treatment of any joint with any of the following agents within 6 months prior to the screening: Any corticosteroid preparation (investigational or marketed), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection)
* Treatment of the index joint with any investigational therapy within 6 months prior to the screening
* Serious life-threatening conditions
* Allergies to anesthesia
* Subject who is breastfeeding.

Where it's running

• Orthopedic & Sports Medicine Institute of Las Vegas
  Las Vegas, Nevada, United States Recruiting

Study contacts

• Study coordinator: Vince Liguori
• Email: vince@agebiomed.com
• Phone: 847-561-0217

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.