Burn patients who have serious wounds often need an autograft. What is an autograft? It is the harvesting of healthy skin of the burn patient which is transplanted at the site of the burn. However, now there is regenerative alternative medicine. The FDA has finally approved a new engineered skin that will be settled over the wound and will serve as a scaffold for the patient’s skin cells to grow.
The division that handles regulations for this product which is named StrataGraft will treat adults who have burn injuries that have left some skin layers that are deep, intact. This medicine has been created by Dublin-based Mallinckrodt Pharmaceuticals. This product is meant to decline the requirements of autografts. The autograft procedure can often lead to more complications and leave patients with a new site that needs healing.
The FDA has based its support on two clinical trial results that enrolled 101 adults with thermal burns that had deep partial thickness. These burns were mostly caused by heat sources like hot surfaces, fire, or scalding water. In both trials, patients served as control and as test subjects. Each patient was identified with two separate burn wounds of similar depth and area. The wounds were selected randomly for treatment, one wound received autograft and the other was treated with StrataGraft.
The trial’s goal was to compare the percentage of treatment sites of StrataGraft that completed wound closure and eliminated the requirement of more treatment using an autograft. One out of two studies was published recently in Burns, a Journal. The study should that StrataGraft treatment eliminated the requirement of harvesting tissue for autograft in 68 patients out of 71. Three months of data showcased that 92 percent of wounds treated by StrataGraft had closed.
StrataGraft is created using human cells of two kinds which are dermal fibroblasts and keratinocytes. These skin cells grow together and create a scaffold or bi-layered construct. The medicine that is 100 sq. centimeters is only for topical use. The StrataGraft’s size should be applied equally to the wound’s surface area as per the prescription. The cells can be trimmed to fit the size of the wound.
StrataGraft is created by using cells that are donated from humans and some materials derived from animals. The FDA has cautioned that this product may involve a risk of infectious disease transmission. However, the clinical trials did not have any such issue. The patient’s immune systems did not decline StrataGraft as a foreign agent and no infections were reported either. The most seen side effect of this treatment was itching which happened to 11 patients. There were other side effects which were scarring, blisters, and slow healing at the wound site.
StrataGraft is one of the very first products to be approved by the FDA in the Regenerative Medicine Advanced Therapy category. The absolute first RMAT approved product was Breyanzi, which is a cancer cell therapy by Bristol Myers Squibb.