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

Knee Osteoarthritis Clinical Trial

Official title:

A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485157
• Other study ID #: AIOA001
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2018
• Est. completion date: April 19, 2022

Study information

• Verified date: December 2023
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Drug:
• Saline
Injection of 1 mL 0.9% Sodium Chloride, USP

Locations

Country	Name	City	State
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	MedSport	Ann Arbor	Michigan
United States	Paragon Sports Medicine	Atlanta	Georgia
United States	Central Research Associates, Inc	Birmingham	Alabama
United States	Arthritis Care Specialist of Maryland	Columbia	Maryland
United States	Wake Reseach	Durham	North Carolina
United States	UConn Health	Farmington	Connecticut
United States	SAMMC	Fort Sam Houston	Texas
United States	Bone & Joint Inst. at Hartford Hospital	Hartford	Connecticut
United States	Hinsdale Orthopedics	Hinsdale	Illinois
United States	Horizon Clinical Research	La Mesa	California
United States	Weill Cornell Medicine	New York	New York
United States	Wake Research	Raleigh	North Carolina
United States	Ortho Virginia	Richmond	Virginia
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	University Orthopedics Center	State College	Pennsylvania
United States	Fiel Family and Sports Medicine	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days	VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain	Up to 365 days
Other	Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 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.	Up to 365 days
Other	Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days	VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction	Up to 365 days
Other	Exploratory Endpoint: Change From Baseline in the KOOS Scores at 90, 180, 270, and 365 Days	Knee Injury and Osteoarthritis Outcome Score (KOOS): 5 subscales scored on a 5 point scale where the final score is summed and transformed into a 100 point scale with a higher score representing no disability and a lower score representing extreme disability	Up to 365 days
Primary	Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days	Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain	90 days
Primary	Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 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.	90 days
Primary	Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)	Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported	365 days
Primary	Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)	Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported	365 days
Primary	Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events	Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported	365 days
Secondary	Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days	Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain	180 days
Secondary	Secondary Endpoint:Change From Baseline in WOMAC at 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.	180 days