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

NCT03441607 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: BX001
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  Decreased Pain Level

  3 Months

Secondary Outcomes (1)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1.

  3 Months

Study Arms (2)

Drug

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

mHACMb DRUG

Active ingredient

Also known as: 40mg FloGraft (micronized human amnion chorion membrane)®, 100mg FloGraft (micronized human amnion chorion membrane)®

Drug

placebo OTHER

inactive ingredient

Also known as: saline

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Applied Biologics, LLC: lead

Study Sites (1)

Texas Orthopedic Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Edward Britt

  Applied Biologics, LLC

  STUDY DIRECTOR

Central Study Contacts

Samantha Montgomery

CONTACT

602-325-1221; samantha.montgomery@appliedbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 22, 2018
• Study Start: November 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)