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

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Saline; Biological: Micronized dHACM

• Registration Number: NCT03485157
• Lead Sponsor: MiMedx Group, Inc.

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.

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-26
• Study Start: 2018-03-27
• Study First Posted: 2018-04-02
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Results First Submitted: 2023-05-31
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Results First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Injection of 0.9% Sodium Chloride Injection, USP
Micronized dHACM	Micronized dHACM	Injection of micronized dHACM

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)	365 days	Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days	90 days	Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales: * Pain (5 questions); * Stiffness (2 questions); * Physical Function (17 questions); The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.; Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)	365 days	Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days	90 days	Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events	365 days	Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days	180 days	Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Secondary Endpoint:Change From Baseline in WOMAC at 180 Days	180 days	Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales: * Pain (5 questions); * Stiffness (2 questions); * Physical Function (17 questions); The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.; Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Trial Locations

Locations (16)

Fiel Family and Sports Medicine; 🇺🇸 Tempe, Arizona, United States

UConn Health; 🇺🇸 Farmington, Connecticut, United States

Horizon Clinical Research; 🇺🇸 La Mesa, California, United States

Ortho Virginia; 🇺🇸 Richmond, Virginia, United States

SAMMC; 🇺🇸 Fort Sam Houston, Texas, United States

Central Research Associates, Inc; 🇺🇸 Birmingham, Alabama, United States

Paragon Sports Medicine; 🇺🇸 Atlanta, Georgia, United States

Gulfcoast Research Institute; 🇺🇸 Sarasota, Florida, United States

Bone & Joint Inst. at Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Hinsdale Orthopedics; 🇺🇸 Hinsdale, Illinois, United States

Arthritis Care Specialist of Maryland; 🇺🇸 Columbia, Maryland, United States

Wake Reseach; 🇺🇸 Durham, North Carolina, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States

MedSport; 🇺🇸 Ann Arbor, Michigan, United States

Wake Research; 🇺🇸 Raleigh, North Carolina, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States