Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT06606561
Eligibility Criteria:
Inclusion Criteria:
1. Age eligible for study: 21 to 75 years
2. Gender eligible for study: All
3. Study subjects must be willing to give written informed consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
4. Subjects have a diagnosis of OA in at least one knee defined as Grade II or III on Kellgren-Lawrence (K-L) grading scale which is confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10o caudal beam angulation.
5. Subjects with VAS pain score ≥40 mm on screening day will be included.
6. Subjects had one or more of the following SOC treatments within the previous 12 months will be included:
1. weight loss
2. physical therapy
3. anti-inflammatory medications - oral, injections and topical
7. Body mass index (BMI) \< 45kg/m2
8. Subjects must be available for all specified assessments at the study site through the completion of the study.
9. For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment. The FDA-approved and cleared methods for birth control are listed below:
1. Permanent Sterilization
2. Long-Acting Reversible Contraceptives (LARC)
3. Contraceptive Injection
4. Short-Acting Hormonal Methods
5. Barrier Methods
6. Emergency Contraception https://www.fda.gov/consumers/free-publications-women/birth-control
10. Any male subject must agree to use contraceptives and not donate sperm during the study.
11. Patient may be eligible for treatment of both knees if criteria is met for both
Exclusion Criteria:
1. Subjects have evidence of significant and unstable cardiac dysfunction, e.g. acute myocardial infarction and hypertension with uncontrolled blood pressure over 140/90 will be excluded.
2. Subjects at screening with white blood cell count \< 4 x 109 cells/L, hematocrit \<30%, and platelets \<150 x 109 /L will be excluded.
3. Subjects with poorly controlled diabetes (hemoglobin A1C \> 7.5 or fasting blood glucose of \>200) in last 6 months will be excluded.
4. Individuals on dialysis or uncontrolled renal disease will be excluded.
5. Subjects with abnormal hematology, serum chemistry, or urinalysis screening laboratory results will be excluded.
6. Subjects with history of, or ongoing, autoimmune disorder that requires treatment with an immunosuppressive medication will be excluded.
7. Subjects had knee surgery on the targeted knee within 12 months prior to screening and /or planned knee surgery during the study will be excluded.
8. Subjects have a body mass index greater than 45 kg/m2 will be excluded.
9. Subjects whose knee pain is caused by, (i) diffuse edema, extra articular causation (ii) displaced meniscus tear, (iii) full thickness articular cartilage lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans will be excluded.
10. Subjects have rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain will be excluded.
11. Subjects which have evidence or history of malignancy except those who are successfully treated in situ or basal cell skin cancers will not be excluded.
12. Subjects with a history of clotting disorder, anticoagulation therapy that cannot be stopped as prior to infusion will be excluded.
13. Subjects have evidence of liver dysfunction manifested as alkaline phosphatase greater than 345 u/L, total bilirubin greater than 1.65 mg/dL, ALT greater than 275 units/L and/or AST great than 240 units/L will be excluded.
14. Subjects have or had an active infection requiring systemic antibiotics within 2 weeks on enrollment in the study will be excluded.
15. Subjects currently taking anticoagulant therapy (excluding Plavix or Aspirin) will be excluded.
16. Subjects have received an intra-articular hyaluronic acid (HA) or platelet rich plasma (PRP) for the treatment of OA of the target knee within 12 weeks prior to screening will be excluded.
17. Subjects have used an investigational drug or had surgical intervention within 12 weeks of the study enrollment will be excluded.
18. Subjects that are unwilling to stop taking prescription or over the counter pain medication for Osteoarthritis for 7 days prior to any visit will be excluded. Subjects will be permitted to take medications for non-osteoarthritis condition (excluding the one's listed under "Concomitant Medication").
19. Subjects needing or at high risk of requiring systemic steroids during the course of study will be excluded except systemic use of corticosteroid administration for COVID-19 or flare up of non-arthritic condition.
Complete information of dose and timeframe of the medication use will be documented in case report forms (CRF).
20. Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
21. Subjects who are unable to complete all the testing required for the study will be excluded.
22. Subjects on active listing (or expected future listing) for transplant of any organ will be excluded.
23. Be a solid organ transplant recipient. This does not include prior cell-based therapy (\>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
24. Subjects with history of drug abuse (illegal "street" drugs except marijuana (If it is legal use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months).
25. Subjects with untreated HIV infection will be excluded. However, patients can be enrolled if have been treated for HIV and the test negative for HIV viral load but still test positive for antibodies.
26. Subjects with neural or vascular claudication or neurologic disorder including, but not limited to epilepsy, Parkinson\'s disease, dementia, cerebrovascular disease, tumor of the nervous system, and amyotrophic lateral sclerosis will be excluded.
27. Subjects cannot have had a hyaluronic acid injection within 6 months prior to NANOVAE injection
28. Subjects cannot have had a cortisone injection within 3 months prior to NANOVAE Injection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT06606561
Study Brief:
Protocol Section:
NCT06606561