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

Osteoarthritis, Knee Clinical Trial

— OA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03441607
• Other study ID #: BX001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 2018
• Est. completion date: March 2019

Study information

• Verified date: September 2018
• Source: Applied Biologics, LLC
• Contact: Samantha Montgomery
• Phone: 602-325-1221
• Email: samantha.montgomery[@]appliedbiologics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• mHACMb
Active ingredient

Other:
• placebo
inactive ingredient

Locations

Country	Name	City	State
United States	Texas Orthopedic Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Applied Biologics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Decreased Pain Level	3 Months
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC®) osteoarthritis Index 3.1.	Decrease in pain, stiffness, and physical functioning of the joints.	3 Months