An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
NCT ID: NCT04201743
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2020-03-30
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT04612023
Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis
NCT03074526
Evaluation of Amniotic Fluid Product in Knee Osteoarthritis
NCT02768155
Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
NCT03337243
Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.
NCT04698265
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.
Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 mL NyDYN injection
30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.
Acellular amniotic membrane derived allograft injection (NuDYN)
Injectable acellular amniotic membrane derived allograft (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) in the treatment of knee osteoarthritis.
2 mL NyDYN injection
30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.
Acellular amniotic membrane derived allograft injection (NuDYN)
Injectable acellular amniotic membrane derived allograft (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) in the treatment of knee osteoarthritis.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acellular amniotic membrane derived allograft injection (NuDYN)
Injectable acellular amniotic membrane derived allograft (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) in the treatment of knee osteoarthritis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
Exclusion Criteria
* BMI greater than 40 kg/m2
* Subject has 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.
* Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
* Subject has documented history of gout or pseudo-gout
* Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
* Subject has received any of the following to the target knee:
1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
4. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
* History of partial or total knee arthroplasty
* Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
* Subject has a history of immunosuppressive or chemotherapy in the last 5 years
* Subject has had prior radiation at the site
* Subject is currently taking narcotic medication for any reason.
* Subject is pregnant or plans to become pregnant within 365 days of treatment
* Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
* Subject is a worker's compensation patient
* Subject is a prisoner
21 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Illinois Center for Orthopaedic Research and Education
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ronak M. Patel
President
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ronak Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Illinois Center for Orthopedic Research and Education (iCORE)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hinsdale Orthopaedic Associates
Westmont, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
199608
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.