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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT03984461
Eligibility Criteria:
Inclusion Criteria:
1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
2. Male or female at least 19 years of age at the time of providing written informed consent.
3. Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren \& Lawrence Grades 1-3 are accepted for participation.
Exclusion Criteria:
1. BMI \> 35
2. Arthroscopic surgery to the treatment joint within 12 months
3. Cortisone or HA injection within the last 3 months prior to stem cell injection
4. Inability to hold antiplatelet therapy according to treating provider prior to procedure
5. Kellgren \& Lawrence Grade 4 Osteoarthritis
6. Participants with a platelet count less than 100 x 109
7. Participants with a Hemoglobin less than 100 g/L
8. Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
9. Participants with an active Cancer diagnosis.
10. Participants with autoimmune disorders including rheumatoid arthritis and lupus.
11. Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
12. Participants with allergies to lidocaine, heparin, or epinephrine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT03984461
Study Brief:
Protocol Section:
NCT03984461