Safety & Efficacy FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to OA of the Knee
NCT ID: NCT03441607
Last Updated: 2018-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
320 participants
INTERVENTIONAL
2018-11-30
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
mHACMb
Active ingredient
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.
placebo
inactive ingredient
Interventions
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mHACMb
Active ingredient
placebo
inactive ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
30 Years
ALL
No
Sponsors
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Applied Biologics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Britt
Role: STUDY_DIRECTOR
Applied Biologics, LLC
Locations
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Texas Orthopedic Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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BX001
Identifier Type: -
Identifier Source: org_study_id
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