Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoart… (NCT02844751) | Clinical Trial Compass
RecruitingPhase 2
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
United States4,000 participantsStarted 2015-07
Plain-language summary
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury.
. Patients range from 18-90 years of age.
. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
. Patients with adequate cardiac and respiratory function.
. Patients must have adequate immune system function, with no known immunodeficiency disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score)
. Greater than 6 months knee pain on the index side (left or right knee).
Exclusion criteria
. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
. Patients infected with hepatitis B, C or HIV.
. Patients with Body Mass Index (BMI) \> 40kg/m2
. Presence of active infection.
. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to: