Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

NCT ID: NCT03485157

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2022-04-19

Brief Summary

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

Detailed Description

Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.

Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Micronized dHACM

Injection of micronized dHACM

Group Type: EXPERIMENTAL

Micronized dHACM

Intervention Type: BIOLOGICAL

Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP

Saline

Injection of 0.9% Sodium Chloride Injection, USP

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Injection of 1 mL 0.9% Sodium Chloride, USP

Interventions

Micronized dHACM

Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP

Intervention Type: BIOLOGICAL

Saline

Injection of 1 mL 0.9% Sodium Chloride, USP

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 21 and ≤ 80 years

2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale

3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

4. Subject must have a VAS pain scale greater than 45

Exclusion Criteria

1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale

2. BMI greater than 40 kg/m^2

3. Subject has active infection at the injection site

4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.

5. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer

6. Subject has documented history of gout or pseudo-gout

7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV

8. Subject has received any of the following to the target knee:

1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening

2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening

3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment

4. History of a total knee arthroplasty

9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment

10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years

11. Subject has had prior radiation at the site

12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)

13. Subject is pregnant or plans to become pregnant within 365 days of treatment

14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation

15. Subject is a worker's compensation patient

16. Subject is a prisoner

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfred C Gellhorn, MD

Role: PRINCIPAL_INVESTIGATOR

Esprit R&D Associate GSK

Locations

Central Research Associates, Inc

Birmingham, Alabama, United States

Fiel Family and Sports Medicine

Tempe, Arizona, United States

Horizon Clinical Research

La Mesa, California, United States

UConn Health

Farmington, Connecticut, United States

Bone & Joint Inst. at Hartford Hospital

Hartford, Connecticut, United States

Gulfcoast Research Institute

Sarasota, Florida, United States

Paragon Sports Medicine

Atlanta, Georgia, United States

Hinsdale Orthopedics

Hinsdale, Illinois, United States

Arthritis Care Specialist of Maryland

Columbia, Maryland, United States

MedSport

Ann Arbor, Michigan, United States

Weill Cornell Medicine

New York, New York, United States

Wake Reseach

Durham, North Carolina, United States

Wake Research

Raleigh, North Carolina, United States

University Orthopedics Center

Altoona, Pennsylvania, United States

University Orthopedics Center

State College, Pennsylvania, United States

SAMMC

Fort Sam Houston, Texas, United States

Ortho Virginia

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AIOA001

Identifier Type: -

Identifier Source: org_study_id