Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06485843 | RECRUITING | Osteoarthritis

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
Sponsor:

Ageless Biotech, Inc.

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.

Condition or disease

Osteoarthritis

Osteo Arthritis Knee

Intervention/treatment

OA-SYS

Phase

PHASE2

Detailed Description:

PURPOSE OF THE STUDY The goal of this clinical trial is to evaluate the safety and tolerability of a treatment called OA-SYS for moderate to severe osteoarthritis (OA) of the knee. Osteoarthritis is a common condition that affects the joints and can cause significant pain and disability, especially in older adults. The study aims to see if OA-SYS is a safe and effective treatment option for people with knee osteoarthritis. STUDY TREATMENT Participants in this study will receive the OA-SYS treatment, which involves the use of adult stem cells (ASCs). The main questions the study aims to answer are: * Is OA-SYS safe and well-tolerated by participants with moderate to severe knee osteoarthritis? * Does OA-SYS help reduce the symptoms and improve the function of the knee joint? Participants will: * Receive the OA-SYS treatment, which includes adult stem cells, administered to the knee joint. * Attend regular clinic visits for check-ups and monitoring. * Report any side effects or changes in their condition throughout the study period. RANDOMIZATION AND BLINDING This is a phase II open-label clinical trial, blinding is not applicable to this study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-10
Estimated Primary Completion Date : 2028-03
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT06485843

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Nevada

Orthopedic & Sports Medicine Institute of Las Vegas

vegas, Nevada, United States, 89117