OA-SYS for Osteoarthritis

(OA-SYS-01 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ageless Biotech, Inc.

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

Disqualifiers: Heart disease, Autoimmune diseases, Cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the OA-SYS treatment for osteoarthritis?

The research highlights the need for new treatment models for osteoarthritis, suggesting that integrated multidisciplinary programs can be more effective than usual care. This implies that treatments like OA-SYS, which may involve multiple approaches, could potentially improve patient satisfaction and outcomes. ^{1 2 3 4 5}

What safety data exists for OA-SYS or similar treatments for osteoarthritis?

The safety of treatments for osteoarthritis, like OA-SYS, is important to monitor over time. Some treatments, such as hylan G-F 20 injections, have shown mild to moderate local side effects like knee pain and swelling in a small percentage of patients. Nutraceuticals, which are food-based treatments, are considered to have favorable safety profiles for long-term use. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• OA-SYS (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial. [2016]

3. Canada pubmed.ncbi.nlm.nih.gov

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis. [2023]

4. Canada 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Osteoarthritis year in review 2014: rehabilitation and outcomes. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Safety issues in the development of treatments for osteoarthritis: recommendations of the Safety Considerations Working Group. [2016]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Nutraceuticals: potential for chondroprotection and molecular targeting of osteoarthritis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Factors Associated with Adverse Events in Inpatient Elective Spine, Knee, and Hip Orthopaedic Surgery. [2017]