Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

NCT03074526 | Completed DMC

• 1 other identifier: OFORT003
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 4

Brief Summary

To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain

  The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.

  3 month

Secondary Outcomes (4)

• Range of Motion

  3 months

• Knee Injury and Osteoarthritis Outcome Score

  4weeks, 6weeks, 3 months, 16 weeks, 6 months

• SF-12 Health Health Survey

  4weeks, 6weeks, 3 months, 16 weeks, 6 months

• Activity of Daily Living Questionnaire

  4weeks, 6weeks, 3 months, 16 weeks, 6 months

Study Arms (3)

4mL amniotic fluid

ACTIVE COMPARATOR

Amniotic Fluid: 4mL dose of amniotic fluid

Other: Amniotic Fluid

4mL2x amniotic fluid

ACTIVE COMPARATOR

Amniotic Fluid: 4mL 2x dose of amniotic fluid

Other: Amniotic Fluid

4mL Saline Placebo

PLACEBO COMPARATOR

Normal Saline

Other: Saline Placebo

Interventions

Amniotic Fluid OTHER

Amniotic Fluid

4mL amniotic fluid; 4mL2x amniotic fluid

Saline Placebo OTHER

Saline Placebo

4mL Saline Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is 30 years or older.
• Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
• Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
• Subject must have a VAS pain scale greater than 30.

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 45 kg/m2
• Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
• Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
• Subject has had major surgery 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 has a history of immunosuppressive or chemotherapy in the last 5 years
• Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
• Subject has had prior radiation at the site
• Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
• New diagnosis of gout in the past 6 month
• Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (4)

Central Research Associates, Inc

Birmingham, Alabama, 35205, United States

Location

Southeastern Center for Clinical Trials

Atlanta, Georgia, 30033, United States

Location

Weil Foot, Ankle and Orthopedic Institute

Des Plaines, Illinois, 60016, United States

Location

Hinsdale Orthopaedic Associates

Hinsdale, Illinois, 60521, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• David Mason, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x).

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: March 8, 2017
• Study Start: January 23, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)