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

NCT04201743 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 199608
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee; Amniotic membrane; Allograft

Outcome Measures

Primary Outcomes (3)

• Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

  Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

  180 days

• Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).

  180 days

• Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

  Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

  180 days

Secondary Outcomes (3)

• Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

  90, 180 and 365 days

• Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

  90, 180 and 365 days

• Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

  90, 180 and 365 days

Study Arms (2)

1 mL NyDYN injection

ACTIVE COMPARATOR

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

Drug: Acellular amniotic membrane derived allograft injection (NuDYN)

2 mL NyDYN injection

ACTIVE COMPARATOR

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

Drug: Acellular amniotic membrane derived allograft injection (NuDYN)

Interventions

Acellular amniotic membrane derived allograft injection (NuDYN) DRUG

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.

1 mL NyDYN injection; 2 mL NyDYN injection

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
• Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
• Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
• 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

Sponsors & Collaborators

• Illinois Center for Orthopaedic Research and Education: lead

Study Sites (1)

Hinsdale Orthopaedic Associates

Westmont, Illinois, 60559, United States

Location

Related Publications (2)

• 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.

  PMID: 26585668 BACKGROUND

• 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.

  PMID: 26683979 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ronak Patel, MD

  Illinois Center for Orthopedic Research and Education (iCORE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. 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.

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 17, 2019
• Study Start: March 30, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)