OA-SYS for Osteoarthritis

(OA-SYS-01 Trial)

Overseen By Mukesh Kumar, PhD RAC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ageless Biotech, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, Biologics, others

Disqualifiers: Heart disease, Autoimmune diseases, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OA-SYS to determine its safety and tolerability for individuals with moderate to severe osteoarthritis in the knee. It targets those experiencing significant knee issues, such as frequent pain or stiffness, due to osteoarthritis. Suitable participants should be in good health and have not undergone recent surgeries or other treatments on the knee. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important advancements in osteoarthritis care.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you must avoid certain treatments restricted by the study from the screening through the end of treatment. If you are on immunosuppressants or have had certain joint treatments recently, you may need to stop those before joining.

Is there any evidence suggesting that OA-SYS is likely to be safe for humans?

Research shows that OA-SYS is being tested for safety and tolerability in treating knee osteoarthritis. While specific side effects for OA-SYS are not yet available, the current study phase typically provides early evidence of its safety.

Researchers assess how well patients manage the treatment and any side effects that occur. Reaching this stage usually indicates that initial tests did not reveal major safety concerns. As the study progresses, more information will confirm how safe and well-tolerated OA-SYS is for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about OA-SYS for osteoarthritis because it offers a fresh approach compared to standard treatments like NSAIDs and corticosteroid injections. Unlike these options, OA-SYS might work by a novel mechanism targeting the underlying causes of joint degeneration rather than just alleviating symptoms. This could potentially lead to not only improved pain relief but also better long-term joint health. Additionally, if OA-SYS shows faster or more sustained results, it could significantly enhance the quality of life for those with osteoarthritis.

What evidence suggests that OA-SYS might be an effective treatment for osteoarthritis?

Research has shown that OA-SYS could help treat knee osteoarthritis (OA). OA-SYS aims to improve joint function by reducing inflammation, which causes pain and stiffness in OA. Early results indicate that treatments targeting inflammation have helped patients experience less pain and improved mobility. Although specific data on OA-SYS remains limited, its method resembles other successful treatments. These indications suggest that OA-SYS might effectively manage OA symptoms. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions

I am able to walk and generally healthy.

I am between 35 and 75 years old with a BMI under 39.

Exclusion Criteria

I have not had injections like sodium hyaluronate in my joints in the last 6 months.

Allergies to anesthesia

Subject who is breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the OA-SYS treatment, which includes adult stem cells administered to the knee joint

52 weeks

Regular clinic visits for check-ups and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OA-SYS

Trial Overview 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.

How Is the Trial Designed?

Group I: OA-SYS Experimental Treatment 1 Intervention

Treatment with OA-SYS

Who Is Running the Clinical Trial?

Ageless Biotech, Inc.

Lead Sponsor

Trials

1

Recruited

400+

Published Research Related to This Trial

Patients with osteoarthritis who participated in a new integrated multidisciplinary outpatient program reported significantly higher satisfaction with their healthcare compared to those receiving usual care, with a mean difference of -1.05 on a satisfaction scale after 4 months.

While the multidisciplinary program improved self-efficacy regarding symptoms, it did not lead to clinically relevant improvements in health outcomes, and some pain and fatigue scores worsened at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. Moe, RH., Grotle, M., Kjeken, I., et al.[2016]

In a 5-year study of patients receiving multiple courses of hylan G-F 20 injections for osteoarthritis knee pain, the incidence of local adverse events (AEs) increased with each treatment course, from 3.4% in the first course to 17.3% in the third course.

Most local AEs were mild to moderate and lasted less than 48 hours, suggesting that while there is a slight increase in risk with repeated treatments, the benefits of pain relief from hylan G-F 20 may outweigh the risks for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hylan G-F 20 tolerability with repeat treatment in a large orthopedic practice: a retrospective review. Waddell, DD., Bricker, DC.[2006]

Intraarticular hyaluronic acid (HA) injections show a small but significant improvement in knee function for individuals with osteoarthritis, with a pooled analysis from 18 randomized controlled trials indicating a standardized mean difference favoring HA at 6 months.

The safety profile of HA injections is favorable, with few serious adverse events reported and no significant differences in non-serious adverse events compared to placebo, highlighting the need for standardized reporting to accurately assess the balance of benefits and harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews. O'Hanlon, CE., Newberry, SJ., Booth, M., et al.[2018]

The paper proposes a method to estimate the acceptable number of serious adverse events (SAEs) per 1000 patient-years for new osteoarthritis treatments, emphasizing the need for ongoing safety monitoring during clinical trials.

It highlights the importance of balancing safety and efficacy in developing new therapies for osteoarthritis, suggesting that a higher risk profile may be acceptable if the treatment offers significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues in the development of treatments for osteoarthritis: recommendations of the Safety Considerations Working Group. Strand, V., Bloch, DA., Leff, R., et al.[2016]

In a study of 2,146 patients undergoing elective knee, hip, and spine surgeries for degenerative conditions, the overall adverse event rate was 27%, with spinal surgeries having the highest rate of severe adverse events.

Key risk factors for adverse events included increasing age, male sex, longer operative duration, longer hospital stays, and undergoing revision surgery, highlighting the need for careful patient assessment and procedural efficiency improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. Millstone, DB., Perruccio, AV., Badley, EM., et al.[2017]

The adoption of the OMERACT-OARSI core outcome set (COS) in hip and knee osteoarthritis trials decreased significantly from 61% in 1997-2001 to 38% in 2012-2016, highlighting a concerning trend in trial reporting.

While pain and physical function were the most commonly included domains in these trials, the patient's global assessment was notably underrepresented, being included in only 48% of studies, indicating a need for improved adherence to COS guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017. Smith, TO., Mansfield, M., Hawker, GA., et al.[2023]

A survey of 618 knee osteoarthritis patients in Thailand revealed that their quality of life (QoL) was very poor, with a mean score of only 33.8, and only 2.1% found it easy to access medical care when needed.

The study found that both health system factors and patient self-management significantly influenced QoL, highlighting the need for improved health services tailored to patients' socioeconomic status and disease severity to enhance accessibility and QoL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with access to health services and quality of life in knee osteoarthritis patients: a multilevel cross-sectional study. Choojaturo, S., Sindhu, S., Utriyaprasit, K., et al.[2020]

A comprehensive update to the core domain set for clinical trials in hip and/or knee osteoarthritis (OA) was achieved through a systematic review and an international Delphi survey involving 426 participants from 25 countries.

The final consensus identified six mandatory domains to be measured in all OA clinical trials: pain, physical function, quality of life, patient's global assessment of the target joint, adverse events (including mortality), and joint structure under specific circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis. Smith, TO., Hawker, GA., Hunter, DJ., et al.[2023]

Osteoarthritis (OA) currently has no cure and existing treatments mainly relieve pain without slowing disease progression, highlighting the need for safer, long-term disease-modifying therapies.

Nutraceuticals, which are food products with health benefits, show promise in modifying OA symptoms and disease progression, with many patients already using them; this review discusses their efficacy and mechanisms, suggesting a novel strategy for OA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutraceuticals: potential for chondroprotection and molecular targeting of osteoarthritis. Leong, DJ., Choudhury, M., Hirsh, DM., et al.[2023]

A systematic review of 36 studies on rehabilitation for hip and knee osteoarthritis (OA) in 2013 found that combining diet for weight loss with exercise is crucial for improving OA disease markers, pain, physical function, and overall health.

The evidence supporting the efficacy of exercise and passive strategies (like thermal modalities and manual therapy) for pain relief was of low to moderate quality, indicating that while these methods can help, they may not be as effective as diet and exercise combined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoarthritis year in review 2014: rehabilitation and outcomes. Maly, MR., Robbins, SM.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06485843

An Study to Evaluate Safety and Tolerability of OA-SYS in ... 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.

2. withpower.com withpower.com/trial/phase-2-osteoarthritis-of-the-knee-8-2024-5e1cb

OA-SYS for Osteoarthritis A survey of 618 knee osteoarthritis patients in Thailand revealed that their quality of life (QoL) was very poor, with a mean score of only 33.8, and only 2.1% ...

3. oarsijournal.com oarsijournal.com/article/S1063-4584(24)01323-2/fulltext

Osteoarthritis Year In Review 2024: Rehabilitation and ... This Year in Review presents key highlights from recent research relating to osteoarthritis rehabilitation and its outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746515/

The osteoarthritis prevention study (TOPS) - PMC Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1063458424013232

Osteoarthritis Year In Review 2024: Rehabilitation and ... This Year in Review presents key highlights from recent research relating to osteoarthritis rehabilitation and its outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11857085/

Effectiveness and Safety of SYSADOAs Used in Eastern ... Osteoarthritis (OA) is a common chronic degenerative joint disease, leading to joint pain, tenderness, limited movement, and a reduced quality of life, thereby ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/541055

An Study to Evaluate Safety and Tolerability of OA-SYS in ... 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.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2665913124001006

A phase III study to evaluate the long-term safety and ... Primary safety endpoints included adverse events, adjudicated arthropathies (AAs), and joint replacements (JRs). Co-primary endpoints of an efficacy sub-study ...