Knee OsteoarthritisPhase 2NCT03485157
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
A Phase 2 study testing Micronized dHACM and Saline in people with Knee Osteoarthritis, run by MiMedx Group, Inc. at 17 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Micronized dHACM and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 447 participants
- Where
- 17 sitesUnited States
- Study dates
- 27 Mar 2018to 19 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
MedSport
Ann Arbor, Michigan, 48106
Paragon Sports Medicine
Atlanta, Georgia, 30327
Central Research Associates, Inc
Birmingham, Alabama, 35205
Arthritis Care Specialist of Maryland
Columbia, Maryland, 21046
Wake Reseach
Durham, North Carolina, 27704
UConn Health
Farmington, Connecticut, 06030
SAMMC
Fort Sam Houston, Texas, 78234
Bone & Joint Inst. at Hartford Hospital
Hartford, Connecticut, 06106
Hinsdale Orthopedics
Hinsdale, Illinois, 60521
Horizon Clinical Research
La Mesa, California, 91942
Weill Cornell Medicine
New York, New York, 10065
Wake Research
Raleigh, North Carolina, 27612
Ortho Virginia
Richmond, Virginia, 23294
Gulfcoast Research Institute
Sarasota, Florida, 34232
University Orthopedics Center
State College, Pennsylvania, 16801
Fiel Family and Sports Medicine
Tempe, Arizona, 85283
About this study
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
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
Read the 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
- Being tested
- Micronized dHACM, Saline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized dHACMBiological
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
SalineDrug
Injection of 1 mL 0.9% Sodium Chloride, USP
| Study group | Role | What they receive |
|---|---|---|
| Micronized dHACM | Experimental | Injection of micronized dHACM Receives: Biological: Micronized dHACM |
| Saline | Placebo comparator | Injection of 0.9% Sodium Chloride Injection, USP Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
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.
Measured: 90 days
Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
Measured: 365 days
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
Measured: 365 days
Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
Measured: 365 days
Secondary outcomes (2)
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
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start27 Mar 2018
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfred C Gellhorn, MD, Principal investigator, Esprit R&D Associate GSK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485157
- Sponsor's protocol ID
- AIOA001
- Status last verified
- Dec 2023
- First submitted
- 20 Mar 2018
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03485157
- Acronym / sponsor ID
- AIOA001
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronized dHACM | Experimental | Biological: Micronized dHACMInjection of micronized dHACM |
| Saline | Placebo comparator | Drug: SalineInjection of 0.9% Sodium Chloride Injection, USP |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized dHACMInjection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP | Biological | Micronized dHACM |
| SalineInjection of 1 mL 0.9% Sodium Chloride, USP | Drug | Saline |
Primary outcome
Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days
Time frame: 90 days
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days
Time frame: 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)
Time frame: 365 days
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)
Time frame: 365 days
Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events
Time frame: 365 days
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
2 secondary outcomes
Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days
Time frame: 180 days
Secondary Endpoint:Change From Baseline in WOMAC at 180 Days
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred C Gellhorn, MD principal investigator
Esprit R&D Associate GSK
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micronized dHACM and Saline in people with Knee Osteoarthritis, run by MiMedx Group, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.