CLINICAL

One of the most severe complications to diabetes is foot ulcers, which affects up to 26 million annually. Lower limb amputation is a feared complication associated with foot ulcers, and globally a person is amputated every 30 sec due to diabetes. There is currently no effective cure for this indication. Cell2Cure will investigate safety and efficacy of treatment with allogeneic subcutaneous injection of C2C-ASC in addition to conventional treatments for healing and complications of foot ulcers in diabetes patients. A total of 30 patients will be randomized 1:1 either to C2C_ASC treatment or to a control group.

Lung transplantation is the ultimate treatment of patients with severe lung disease. However, the short- and long-term prognosis is still problematic due to immunological reactions towards the transplanted lung. To treat this serious complication the Chronic Lung Allograft dysfunction (Lung transplant rejection) a phase I-II trial has been finalized. Patients were randomized to double-blind treatment with intravenous infusion of 100 million ASCs, 200 million ASCs or saline. Data are expected to be ready for read-out Q3-Q4 2023.

Dilated non-ischemic heart failure is a serious condition with a high morbidity and mortality (40-50 %/5 years). The prevalence is estimated to be 1 :250-500 in different registers. Dilated non-ischemic heart failure is the most frequent cause for heart transplantation.  In an ongoing academic collaboration ASC safety and regenerative capacity is tested in 30 patients with dilated non-ischemic heart failure, as these patients present a high degree of inflammatory and immunological activity in the disease pathology. C2C will explore the regenerative effect of C2C_ASC treatment in patients with dilated non-ischemic heart failure.

With more than 180000 procedures annually, cornea transplantation/keratoplasty is the most frequent, transplantation procedure of human tissue. The 5-year prognosis for cornea transplant survival is estimated to be as low as 50%, which is poorer than that for solid organ transplants. C2C will in a collaboration with Department of Ophthalmology, Royal Victoria Eye and Ear Hospital, Dublin, Ireland, investigate if a single preoperative subconjunctival injection of C2C_ASC is safe and reduces the risk of immunological rejection in high-risk keratoplasty.

Children with autism spectrum disorder (ASD) have an increased incidence of gastrointestinal complications with symptoms such as abdominal pain and diarrhea. In leaky gut syndrome, gaps in the intestinal walls allow translocation of bacterial products and toxins into the blood stream. This leakage induces local and systemic inflammation. It is hypothesized that these circulating toxins and inflammatory factors influence the behavior and well-being of the children. C2C is conducting a dose titrating C2C_ASC study in children with autism and leaky gut syndrome.