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

• ClinicalTrials.gov Identifier: NCT03441607
• Recruitment Status: Unknown
• First Posted: February 22, 2018
• Last Update Posted: September 28, 2018
• Sponsor: Applied Biologics, LLC
• Information provided by (Responsible Party): Applied Biologics, LLC

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Drug: mHACMb; Other: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Estimated Study Start Date: November 2018
• Estimated Primary Completion Date: February 2019
• Estimated Study Completion Date: March 2019

Arms and Interventions

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 Name: saline

Outcome Measures

Primary Outcome Measures :

1. Visual Analogue Scale (VAS) [ Time Frame: 3 Months ]
   Decreased Pain Level

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Contacts

Contact: Samantha Montgomery; 602-325-1221 ext 9825; samantha.montgomery@appliedbiologics.com

Locations

United States, Texas

Texas Orthopedic Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

Applied Biologics, LLC

Investigators

• Study Director: Edward Britt; Applied Biologics, LLC

More Information

• Responsible Party: Applied Biologics, LLC
• ClinicalTrials.gov Identifier: NCT03441607
• Other Study ID Numbers: BX001
• First Posted: February 22, 2018
• Last Update Posted: September 28, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases