Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||21 Years - 80 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Illinois Center for Orthopaedic Research and Education|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Nikil ChariJacob Barnhart|
|Principal Investigator Affiliation||Research AssistantResearch Assistant|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs.#46;2 mL). 90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms. It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
Active Comparator: 1 mL NyDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.
Active Comparator: 2 mL NuDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.
Placebo Comparator: Placebo of Sterile Saline
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.
Other: - Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.