Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Micronized DHACM · 2 trials · 2 indications
Visual Analog Scale, Left end point is "No Pain". Right end point is "worst pain imaginable"
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
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.
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
| Arm | Type | Description |
|---|---|---|
| Micronized DHACM | EXPERIMENTAL | 1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM) |
| Saline Injection | PLACEBO_COMPARATOR | Injection of 1mL 0.9% Sodium Chloride Injection, USP |
| Saline | PLACEBO_COMPARATOR | Injection of 0.9% Sodium Chloride Injection, USP |
| Name | Type | Description |
|---|---|---|
| Micronized DHACM | BIOLOGICAL | 1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM). |
| Saline Injection | DRUG | Injection of 1mL 0.9% Sodium Chloride Injection, USP |
| Saline | DRUG | Injection of 1 mL 0.9% Sodium Chloride, USP |
Inclusion Criteria All subjects enrolled must meet all the following criteria: 1. Confirmed diagnosis of Achilles tendonitis for ≥ 1 month (30 days) and ≤ 18 months by the investigator 2. VAS Pain scale of ≥ 45 at randomization 3. Achilles Tendonitis with conservative treatment for ≥1 month (30 da...
Micronized DHACM is an investigational injectable being studied for Achilles tendonitis and knee osteoarthritis. It is a micronized form of dehydrated human amnion/chorion membrane, developed by MiMedx Group, Inc (MDXG). The product is in clinical development for these musculoskeletal conditions.
Micronized DHACM is a micronized form of dehydrated human amnion/chorion membrane (dHACM). It is not a monoclonal antibody targeting a specific molecular target; rather, it is a tissue-based product derived from placental membranes. Its mechanism involves providing a scaffold and growth factors to support tissue repair.
Micronized DHACM is developed by MiMedx Group, Inc, a biopharmaceutical company traded on the stock exchange under the ticker MDXG. MiMedx is the developer of this investigational product for musculoskeletal indications.
Micronized DHACM is in Phase 3 clinical development. One Phase 3 trial for Achilles tendonitis has been completed, and a Phase 2 trial for knee osteoarthritis has also been completed. The product is investigational and not yet approved by the FDA.
Micronized DHACM has been studied in two completed trials. NCT03414255 is a Phase 3 trial for Achilles tendonitis with 146 participants, and NCT03485157 is a Phase 2 trial for knee osteoarthritis with 447 participants. Both trials were conducted in the United States.
Micronized DHACM is a micronized form of dehydrated human amnion/chorion membrane (dHACM). The micronized version is processed into smaller particles for injectable use, whereas standard dHACM may be used in other forms. Both are derived from placental tissue.