RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06485843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Vince Liguori

CONTACT

8475610217

vince@agebiomed.com

Study Locations (Sites)

Orthopedic & Sports Medicine Institute of Las Vegas

Las Vegas, Nevada, 89117

United States

Collaborators and Investigators

Sponsor: Ageless Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10

Study Completion Date2028-05

Study Record Updates

Study Start Date2024-10

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

Osteoarthritis
Osteo Arthritis Knee