Dehydrated human amnion/chorion membrane allograft

What is dehydrated human amnion/chorion membrane allograft?

Dehydrated human amnion/chorion membrane allograft is a tissue-based product made from the inner (amnion) and outer (chorion) layers of the human placenta. It is also known by the brand name EpiFix.^[3] The tissue is processed and dehydrated so it can be stored and applied to wounds. It is not a chemically manufactured drug but a biological material derived from donated human tissue after childbirth. In the registry records for the current trial, it is listed as an investigational product being tested for wound care.

How does dehydrated human amnion/chorion membrane allograft work?

The membrane is thought to support wound healing by providing a scaffold of natural tissue components. The amnion and chorion layers contain proteins and growth factors that are part of the body's own healing process. When placed on a wound, the graft is intended to help the body clear away dead or damaged tissue and create a healthier wound bed where new tissue can form. A study of patients with ulcers on free flaps suggested that the grafts may accelerate healing in difficult wounds related to venous insufficiency or lymphedema.^[2]

Which conditions is it used or studied for?

• Venous leg ulcers — open sores on the lower leg caused by poor blood flow in the veins. They are slow to heal and often have dead tissue that needs to be removed. The current Phase 3 trial is studying the allograft for this condition.^[1]
• Ulcers on free flaps — wounds that develop on transplanted tissue used in reconstructive surgery, particularly in people with venous insufficiency or lymphedema. A small clinical report described the use of the graft in 8 such ulcers.^[2]
• Diabetic foot ulcers — the product has been studied for this condition in other research, as noted in a review of clinical trials.^[3]

How is dehydrated human amnion/chorion membrane allograft given?

The allograft is applied directly to the wound surface (topical application). In the current trial, it is used as a 1 cm² square piece placed on the ulcer.^[1] It is a sheet-like material rather than a pill or injection. Because it is dehydrated, it can be stored and prepared for use at the bedside or in a clinic.

What do the clinical trials show?

One clinical trial involving this substance is registered in the EU Clinical Trials Information System. It is a Phase 3 study, which means it is testing the product in a larger group of people to confirm how well it works and how safe it is compared to a placebo. The trial is currently authorised, meaning it has received regulatory approval to proceed but is not yet recruiting participants.

The trial is designed to compare the allograft against a placebo gel and another investigational product called EscharEx. The main goal is to see whether the allograft helps remove dead tissue from venous leg ulcers and whether it helps the wounds close faster. The study will assess complete debridement — the full removal of dead or damaged tissue — after each application during a daily visits period, and will measure the time to complete wound closure during a weekly visits period.^[1]

The trial plans to enrol 273 participants. It is a multicenter study, meaning it will take place at more than one hospital or clinic. The design is randomised, double-blind, and placebo-controlled, which means participants will be assigned by chance to receive either the allograft, the placebo, or EscharEx, and neither the participants nor the researchers will know which treatment is being given until the study is complete. This helps reduce bias in the results.^[1]

What side effects are known?

The provided sources do not contain a specific list of side effects for dehydrated human amnion/chorion membrane allograft. As a tissue-based product applied to wounds, safety is being evaluated in the ongoing Phase 3 trial, which will collect information on any adverse events during treatment.^[1]