OsteoarthritisPhase 2OA-SYS-01NCT06485843
An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
A Phase 2 study testing OA-SYS in people with Osteoarthritis and Osteo Arthritis Knee, run by Ageless Biotech, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Osteoarthritis, Osteo Arthritis Knee
- What is being tested?
- OA-SYS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orthopedic & Sports Medicine Institute of Las Vegas
Las Vegas, Nevada, 89117
Randa Bascharon, DO
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Osteo Arthritis Knee
- Being tested
- OA-SYS
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA-SYSDrug
OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| OA-SYS | Experimental | Treatment with OA-SYS Receives: Drug: OA-SYS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Adverse Events
Presence of adverse events in less than 5% of the study population, as a measure of safety
Measured: 52 weeks
Secondary outcomes (3)
Change in NSAIDs Use
Change in NSAIDS use, until study completion
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 May 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ageless Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485843
- Sponsor's protocol ID
- OA-SYS-01
- Acronym
- OA-SYS-01
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06485843
- Acronym / sponsor ID
- OA-SYS-01 / OA-SYS-01
- Conditions
- Osteoarthritis, Osteo Arthritis Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ageless Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OA-SYS | Experimental | Drug: OA-SYSTreatment with OA-SYS |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OA-SYSOA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis. | Drug | OA-SYS |
Primary outcome
Presence of Adverse Events
Time frame: 52 weeks
Presence of adverse events in less than 5% of the study population, as a measure of safety
3 secondary outcomes
Change in NSAIDs Use
Time frame: 52 weeks
Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 52 weeks
Change in the Visual Analog Scale (VAS)
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OA-SYS in people with Osteoarthritis and Osteo Arthritis Knee, run by Ageless Biotech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vince Liguori (847-561-0217, vince@agebiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Adverse Events (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.