Read highlights from the latest installment of Dusko Ilic’s industry updates, which discuss the latest developments and news in regenerative medicine and stem cell research, and are published every month in Regenerative Medicine.
Every month, Dusko comments on news of note. Read the full update for March 2020 in Regenerative Medicine here>>
What happened this month that you were expecting?
AVITA Medical (Melbourne, Australia) wants their RECELL® technology to be taken seriously and is starting a couple of new clinical trials to evaluate its safety and effectiveness.
In the USA, it is estimated that 30% of burn patients are within the ages of one to 15 years old, and approximately 45% of the pediatric burn injuries are from scald burns. The standard of care for pediatric patients with second-degree burns, such as scald burns, is to apply dressings and assess the injury over time to determine if skin grafting is required.
Skin grafting results in scar formation in the area treated and involves the harvesting of substantial amounts of donor skin, resulting in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discoloration and scarring are all associated with skin graft donor site wounds. The first study seeks to demonstrate that treatment with the RECELL System of partial-thickness burn injuries within 72 hours can safely and effectively increase the incidence of healing at day 10 when compared to a standard wound dressing.
While skin grafting is commonly associated with burn treatment, in 2017 approximately 80% of acute wounds that required skin grafting were non-burn related injuries accounting for more than 200,000 procedures in the US. The second study, a prospective multi-center trial of at least 65 patients will compare the clinical performance of conventional skin grafting to the use of the RECELL System in combination with more widely meshed autografts on acute full-thickness non-burn skin defects.
What happened that surprised you this month?
The genie is out of the bottle again! The mesenchymal stromal/stem cell (MSC) field cannot be stopped. MSCs are now the solution for COVID-19. At least five companies from the USA, Australia and Israel are jumping on the COVID-19 band wagon claiming that the COVID-19 patients with a severe pneumonia would not progress towards acute respiratory distress syndrome and sepsis if they are treated with MSCs. Regulatory bodies are rushing who will be the first one to approve these controversial treatments. O tempora, o mores!
If we only read about one story this month, what should it be?
The story is not about a cellular therapy or stem cells, however, it can be loosely classified as a regenerative medicine. Oregon Health & Science University (OHSU; OR, USA) made history with a clinical trial sponsored by Allergan (Ireland) and Editas Medicine (MA, USA). The gene-editing tool CRISPR has been used to address a blindness-causing gene mutation in vivo.
Clinicians within OHSU’s Casey Eye Institute performed the procedure for the BRILLIANCE clinical trial, which seeks to repair mutations in the CEP290 gene that cause a rare form of inherited blindness called Leber congenital amaurosis type 10; also known as LCA10 and CEP290-related retinal dystrophy. Most people with the mutation are either born blind or become blind within the first decade of their life. The procedure marks the first time CRISPR has been used to edit human genes within the body, which is also called in vivo gene editing. Previous gene editing methods have involved editing genetic material after it was removed from the body. The trial’s gene editing approach is designed to be permanent, but not passed onto the offspring of those who receive it.
Dusko Ilic is a Senior Lecturer in stem cell science, coordinator of the cross-divisional postgraduate program in stem cells and regenerative medicine, and Head of the Induced Pluripotent Stem Cell Core Facility at King’s College London (London, UK). He is also Head of the Assisted Conception Unit’s Human Embryonic Laboratories at Guy’s Hospital (London, UK). He is also a member of the editorial board of the journal Regenerative Medicine, where he writes the Industry Report, a regular feature compiling information from non-academic institutions in the field of stem cells and regenerative medicine