Phase 2 Completed N=447 Randomized Double-blind Treatment

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

Knee Osteoarthritis

Source: ClinicalTrials.gov NCT03485157 ↗

Enrolled (actual)

447

Serious AEs

4.2%

Results posted

Dec 2023

Primary outcomePrimary: Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days — 32.8; 34.1; -35.1; -34.2 score on a scale

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days	32.8; 34.1; -35.1; -34.2	—
PRIMARY Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days	26.9; 28.8; -20.6; -19.6	—
PRIMARY Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)	123; 120	—
PRIMARY Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)	11; 12	—
PRIMARY Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events	16; 16	—
SECONDARY Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days	31.1; 32.2; -36.9; -36.1	—
SECONDARY Secondary Endpoint:Change From Baseline in WOMAC at 180 Days	26.0; 27.6; -21.6; -20.8	—

Eligibility Criteria

Inclusion Criteria

Age ≥ 21 and ≤ 80 years
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 45

Exclusion Criteria

Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
BMI greater than 40 kg/m^2
Subject has active infection at the injection site
Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
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
Subject has documented history of gout or pseudo-gout
Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
Subject has received any of the following to the target knee:
Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
History of a total knee arthroplasty
Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
Subject has a history of immunosuppressive or chemotherapy in the last 5 years
Subject has had prior radiation at the site
Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
Subject is pregnant or plans to become pregnant within 365 days of treatment
Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
Subject is a worker's compensation patient
Subject is a prisoner

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Data sourced from ClinicalTrials.gov (NCT03485157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.