Who is sponsoring NCT04612023?

NCT04612023 is sponsored by Illinois Center for Orthopaedic Research and Education.

What drugs are being tested in NCT04612023?

Interventions in NCT04612023: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN).

What condition does NCT04612023 study?

NCT04612023 studies Osteoarthritis, Knee.

Is NCT04612023 still recruiting?

NCT04612023 is currently status unknown. Last updated 15 February 2021.

Last reviewed 2021-02-15 · How we verify

NCT04612023

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 2 Last updated 15 February 2021

What this trial tests

Phase 2 trial testing Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) in Osteoarthritis, Knee in 90 participants. Status unknown.

Timeline

18 November 2020

Primary endpoint
2 April 2022

2 July 2022

Quick facts

Lead sponsor	Illinois Center for Orthopaedic Research and Education
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	18 November 2020
Primary completion	2 April 2022
Estimated completion	2 July 2022
Sites	1 location across United States

Drugs / interventions tested

Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) — full drug profile →

Conditions studied

Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Illinois Center for Orthopaedic Research and Education — full company profile →

Who can join

Adults 21 to 80, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Allogenic Amniotic Tissue for Treatment of Knee and Hip Osteoarthritis.
Gupta A. · · 2022 · cited 18× · PMID 35455401 · DOI 10.3390/ph15040404
Allogenic Perinatal Tissue for Musculoskeletal Regenerative Medicine Applications: A Systematic Review.
Aratikatla A, Maffulli N, Rodriguez HC, Gupta M, et al · · 2022 · cited 14× · PMID 36551929 · DOI 10.3390/biomedicines10123173
Amniotic Suspension Allograft for Treatment of Knee Osteoarthritis.
Gupta A. · · 2022 · cited 2× · PMID 36289919 · DOI 10.3390/biomedicines10102658

Verify or expand the search:

Other recruiting trials for Osteoarthritis, Knee

Currently open trials in the same condition.

NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT06488144 — Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans · Phase 3 · recruiting
NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty · NA · active not recruiting
NCT07514598 — Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA) · NA · active not recruiting
NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement · NA · recruiting

Other Illinois Center for Orthopaedic Research and Education trials

Trials by the same sponsor.

NCT06979804 — A Comparison of Outcomes After Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04612023 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Illinois Center for Orthopaedic Research and Education
Last refreshed: 15 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04612023.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing