Clinical trial NCT03441607: Safety & Efficacy FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to OA of the Knee
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Applied Biologics, LLC
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 320
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 3 Months
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1.
timeFrame: 3 Months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Orthopedic Hospital
state: Texas
Study officials:
affiliation: Applied Biologics, LLC
name: Edward Britt
role: STUDY_DIRECTOR
References: