Recruiting
Phase 2

Amniotic Membrane

Sponsor:

Illinois Center for Orthopaedic Research and Education

Code:

NCT04612023

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)

Study Details

Brief summary:

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT04612023

Start date

Nov 18, 2020

Status verified date

Feb, 2021

Completion date

Jul 2, 2022

Anticipated

Primary completion date

Apr 2, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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).

Primary outcome measure

  • Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 1 year ]
  • Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 1 year ]
  • Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Eyal Ginesin, MD

6309292249eginesin@ibji.com

Ronak M Patel, MD

6309292249rpatel@ibji.com

Locations

ICORE

Recruiting

Westmont, Illinois, United States, 60559

Contacts

Ronak M Patel, MD

630-929-2249rpatel@ibji.com

Eyal Ginesin, MD

6309292249eginesin@ibji.com

More Information

Sponsor

Illinois Center for Orthopaedic Research and Education

Last update posted

Feb 15, 2021

Last verified

Feb, 2021

Keywords

  • osteoarthritis
  • amniotic fluid
  • amniotic allograft
  • knee
  • amniotic membrane

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Illinois Center for Orthopaedic Research and Education on 2021-02-15.