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Human Amnion Allograft
Human Amnion Allograft is a Biologic drug developed by University of North Dakota. It is currently FDA-approved. Also known as: AmnioExCel.
Human Amnion Allograft is a product used in clinical trials for various conditions, including Diabetic Foot Ulcer, Venous Leg Ulcer, Degenerative Disc Disease, Spondylolisthesis, and Spondylosis. It is classified as a SEQUESTERING AGENT, specifically a bilirubin sequestering agent, and is derived from protein.
At a glance
| Generic name | Human Amnion Allograft |
|---|---|
| Also known as | AmnioExCel |
| Sponsor | University of North Dakota |
| Modality | Biologic |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers (NA)
- Evaluation of the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns (PHASE4)
- Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
- A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers. (PHASE4)
- Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen Membrane (NA)
- A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (PHASE3)
- Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover (PHASE4)
- The Role of Amnion Membrane Allografts in Nipple Preservation (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Human Amnion Allograft CI brief — competitive landscape report
- Human Amnion Allograft updates RSS · CI watch RSS
- University of North Dakota portfolio CI
Frequently asked questions about Human Amnion Allograft
What is Human Amnion Allograft?
Who makes Human Amnion Allograft?
Is Human Amnion Allograft also known as anything else?
What development phase is Human Amnion Allograft in?
Related
- Manufacturer: University of North Dakota — full pipeline
- Also known as: AmnioExCel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing