Safety & Efficacy FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to OA of the Knee (OA)

Safety & Efficacy of Micronized Human Amnion Chorion Membrane Biologic (mHACMb) FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee

Safety & Efficacy of FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: placebo; Drug: mHACMb

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Samantha Montgomery; Phone Number: 9825 602-325-1221; Email: samantha.montgomery@appliedbiologics.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to provide written informed consent to participate in the study.
• Willing and able to participate in all procedures and follow-up evaluations necessary to complete the study.
• Subject is 30 years or older.
• Moderate OA pain (rating of at least 20mm on the VAS) assessed at Baseline.
• Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at Baseline.
• Must be ambulatory.
• No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure.

Exclusion Criteria:

• Subject has active infection at the injection site.
• Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
• BMI greater than 40 kg/m2.
• Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
• Subject has received an intra-articular amniotic fluid, amniotic membrane or amniotic fluid/membrane combination injection for the treatment of OA of the target knee within 3 months prior to screening.
• Subject has received a steroid, bone marrow aspirate concentrate (BMAC) or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
• Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
• Subject is pregnant or plans to become pregnant within 180 days of treatment.
• Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
• Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
• Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin).
• Diagnosis of gout in the past 6 month.
• Major injury to the target knee within the 12 months prior to the screening.
• Severe hip osteoarthritis ipsilateral to the target knee.
• Any pain that could interfere with the assessment of the target knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug; Intervention: 40 mg of micronized human amnion chorion membrane biologic (mHACMb); administered 1(x) on second visit; followed by 2 follow-up visits for assessment over a duration of 3 months.	Drug: mHACMb; Active ingredient; Other Names: 40mg FloGraft (micronized human amnion chorion membrane)®; 100mg FloGraft (micronized human amnion chorion membrane)®
Placebo Comparator: Placebo; Intervention: 1cc of saline will be administered as a one time injection on visit 2, administered 1(x) on first visit; followed by 2 follow-up visits for assessment over a duration of 3 months.	Other: placebo; inactive ingredient; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Decreased Pain Level	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1.	Decrease in pain, stiffness, and physical functioning of the joints.	3 Months

Collaborators and Investigators

• Sponsor: Applied Biologics, LLC
• Investigators: Study Director: Edward Britt, Applied Biologics, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BX001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No