A Phase 2 interventional study of Micronized dHACM and Saline in Knee Osteoarthritis, sponsored by MiMedx Group, Inc.. Completed at 17 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by MiMedx Group, Inc. · Phase 2, Interventional, and Treatment
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
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 447 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →MiMedx Group, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has received any of the following to the target knee:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Injection of micronized dHACM
Biological: Micronized dHACM
Injection of 0.9% Sodium Chloride Injection, USP
Drug: Saline
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
Injection of 1 mL 0.9% Sodium Chloride, USP
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 365 days
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
Time frame: 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.
Time frame: 180 days
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
Time frame: Up to 365 days
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.
Time frame: Up to 365 days
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
Time frame: Up to 365 days
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
Time frame: Up to 365 days
| Milestone | Micronized dHACM | Saline |
|---|---|---|
| Started | 223 | 224 |
| Completed | 208 | 203 |
| Not completed | 15 | 21 |
| Withdrew: Lost to follow-up | 4 | 4 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Withdrawal by subject | 6 | 9 |
| Withdrew: Removal by pi | 3 | 7 |
| Milestone | Micronized dHACM | Saline |
|---|---|---|
| Started | 108 | 109 |
| Completed | 104 | 104 |
| Not completed | 4 | 5 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Removal by pi | 2 | 0 |
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
| score on a scale | Micronized dHACM | Saline |
|---|---|---|
| Value | 32.8 ± 26.39 | 34.1 ± 26.40 |
| Change from baseline | -35.1 ± 26.72 | -34.2 ± 26.87 |
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.
| score on a scale | Micronized dHACM | Saline |
|---|---|---|
| Value | 26.9 ± 18.43 | 28.8 ± 18.98 |
| Change from baseline | -20.6 ± 18.16 | -19.6 ± 17.99 |
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
| Participants | Micronized dHACM | Saline |
|---|---|---|
| Primary Safety Endpoint: Number of Participants With Adverse Events (AEs) | 123 | 120 |
Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
| Participants | Micronized dHACM | Saline |
|---|---|---|
| Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs) | 11 | 12 |
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
| Participants | Micronized dHACM | Saline |
|---|---|---|
| Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events | 16 | 16 |
Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
| score on a scale | Micronized dHACM | Saline |
|---|---|---|
| Value | 31.1 ± 26.98 | 32.2 ± 27.35 |
| Change From Baseline | -36.9 ± 28.51 | -36.1 ± 27.94 |
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.
| score on a scale | Micronized dHACM | Saline |
|---|---|---|
| Value | 26.0 ± 19.45 | 27.6 ± 19.63 |
| Change From Baseline | -21.6 ± 20.91 | -20.8 ± 20.67 |
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Collected over Adverse Events were collects for 1 year in the double blinded study and 6 months in the Open Label Study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Micronized dHACM | 0/223 (0%) | 11/223 (4.9%) | 123/223 (55.2%) |
| Saline | 0/224 (0%) | 12/224 (5.4%) | 120/224 (53.6%) |
| Open-Label Micronized dHACM | 0/217 (0%) | 5/217 (2.3%) | 94/217 (43.3%) |
| Event | Micronized dHACM | Saline | Open-Label Micronized dHACM |
|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/223 | 2/224 | 0/217 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/223 | 1/224 | 1/217 |
| FallInjury, poisoning and procedural complications | 0/223 | 0/224 | 1/217 |
| Hand fractureInjury, poisoning and procedural complications | 0/223 | 0/224 | 1/217 |
| OverdoseInjury, poisoning and procedural complications | 0/223 | 0/224 | 1/217 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/223 | 0/224 | 1/217 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/223 | 0/224 | 0/217 |
| DiverticulitisInfections and infestations | 1/223 | 0/224 | 0/217 |
| Staphylococcal infectionInfections and infestations | 1/223 | 0/224 | 0/217 |
| Coronary artery occlusionCardiac disorders | 1/223 | 0/224 | 0/217 |
| Event | Micronized dHACM | Saline | Open-Label Micronized dHACM |
|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 47/223 | 49/224 | 29/217 |
| Injection site joint painGeneral disorders | 14/223 | 2/224 | 21/217 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 7/223 | 11/224 | 5/217 |
| Back painMusculoskeletal and connective tissue disorders | 4/223 | 10/224 | 2/217 |
| Injection site joint swellingGeneral disorders | 3/223 | 0/224 | 9/217 |
| Joint swellingMusculoskeletal and connective tissue disorders | 8/223 | 7/224 | 7/217 |
| Oedema peripheralGeneral disorders | 7/223 | 2/224 | 3/217 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 6/223 | 6/224 | 1/217 |
| Ligament sprainInjury, poisoning and procedural complications | 2/223 | 2/224 | 5/217 |
| Joint effusionMusculoskeletal and connective tissue disorders | 5/223 | 4/224 | 1/217 |
Demographic and baseline characteristics of subjects in the ITT Set.
| Age, Continuous(years) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| Mean | 57.89 ± 10.619 | 58.45 ± 11.294 | 58.17 ± 10.954 |
| Sex: Female, Male(Participants) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| Female | 120 | 140 | 260 |
| Male | 103 | 84 | 187 |
| Ethnicity (NIH/OMB)(Participants) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 12 | 24 |
| Not Hispanic or Latino | 211 | 212 | 423 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 24 | 19 | 43 |
| White | 193 | 195 | 388 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Height (in)(Inches) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| Mean | 67.17 ± 4.114 | 66.72 ± 3.748 | 66.94 ± 3.937 |
| Weight(lbs) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| Mean | 187.22 ± 39.629 | 185.12 ± 40.305 | 186.17 ± 39.938 |
| Body Mass Index (BMI)(kg/m^2) | Micronized dHACM | Saline | Total |
|---|---|---|---|
| Mean | 29.74 ± 4.919 | 29.81 ± 5.279 | 29.77 ± 5.097 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Allogeneic human amnion/chorion membrane