An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee

Study Purpose

The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection when compared to a placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 21 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient is a candidate for non-surgical intervention of the knee - Patient must be between the ages of 21 and 80 years old - Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion Criteria:

- Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4 - Patient has a BMI greater than 40 kg/m2, active infection at the injection site, symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy - Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain - Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV - Patient has any of the following treatments to the target knee within 12 weeks prior to screening - Intra-articular hyaluronic acid (HA) injection - Steroid or platelet rich plasma (PRP) injection - Use of any investigational drug, device, or biologic - Patient had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment - Patient has a history of partial or total knee arthroplasty - Patient has undergone immunotherapy or chemotherapy in the last 5 years, prior radiation at the site, or is currently taking a narcotic medication for any reason - Patient is pregnant or plans to become pregnant within 365 days of treatment - Patient has any significant medical condition that would interfere with protocol evaluation and participation - Patient is a recipient of worker's compensation - Patient is a current prisoner

Trial Details

Trial ID:

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.

NCT04612023
Phase

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.

Phase 2
Lead Sponsor

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
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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).

Contact a Trial Team

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.

ICORE, Westmont, Illinois

Status

Address

ICORE

Westmont, Illinois, 60559

Site Contact

Ronak M Patel, MD

[email protected]

630-929-2249