An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) 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 injection 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.

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:

  • - Age of 21 to 80 years - Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale

    Exclusion Criteria:

    - Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale - 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

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.

NCT04201743
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 4
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.

Ronak Patel, MD
Principal Investigator Affiliation Illinois Center for Orthopedic Research and Education (iCORE)
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). 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.

Arms & Interventions

Arms

Active Comparator: 1 mL NyDYN injection

30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.

Active Comparator: 2 mL NyDYN injection

30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.

Interventions

Drug: - 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.

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.

Hinsdale Orthopaedic Associates, Westmont, Illinois

Status

Address

Hinsdale Orthopaedic Associates

Westmont, Illinois, 60559