Clinical Research

Clinical trials provide the crucial step for transforming science into therapy. Discover more about the clinical indications we are focusing on. RHEACELL clinical trial designs can be accessed via clinical trial registries available to the general public at clinicaltrials.gov and clinicaltrialsregister.eu.

Epidermolysis Bullosa (EB): severe genetic pediatric disease

Non-healing chronic venous wounds

Non-healing diabetic foot ulcers

Acute-on-Chronic Liver Failure (ACLF)

Limbal Stem Cell Deficiency (LSCD)

Examining the most severe forms of Epidermolysis bullosa (RDEB and JEB) in conjunction with leading international experts. We are concentrating our efforts on helping the small patient cohort for whom the future looks bleak.

EB is a severe, inherited, clinically and genetically heterogeneous skin disorder. EB patients have extremely fragile skin and mucosa – hence even the slightest trauma or friction can lead to blisters and erosions, and open slowly healing wounds. The life expectancy of EB patients is highly dependent on the inheritance pattern and severity of the disease. In its most severe forms - as a result of side effects (e.g. metastatic skin carcinoma) - EB can culminate in death in early childhood or early adulthood.

There has been no adequate cure for non-healing chronic venous wounds to date. We are focusing on these patients to offer them therapeutic solutions and the option to lead a "normal" life.

CVUs develop following impaired venous drainage in the lower extremities, mainly due to venous reflux or venous outflow obstruction. Elevated venous pressure causes micro-circulatory disturbances, initiating a cascade of pathophysiological events, potentially culminating in tissue breakdown and the onset of painful wounds. To date, there has been no conclusive evidence to suggest that any particular dressing, topical agent or systemic agent can effectively accelerate the venous ulcer healing process. In the severest of cases, surgical intervention to eradicate the underlying cause of venous hypertension is often the last hope.

For more information on our currently ongoing Phase IIb study please visit:
DRKS - German Clinical Trials Register

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb)- ClinicalTrials.gov

Patients with non-healing diabetic foot ulcers are faced with major health risks. We are focusing on these patients to provide them with therapeutic options and avoid complications e.g., amputation, by treating these ulcers with the latest drug.

In diabetes mellitus patients, (diabetic foot ulcers) DFUs are the most common and severest complication, affecting 15% of diabetic patients in their lifetime. DFUs are the primary cause of hospital admissions in this context. It is estimated that approximately 50-70% of total lower limb amputations are due to DFUs. This number is expected to rise further, reflecting the increasing number of diabetic patients from 463 million in 2019 to 700 million by 2045 and obese patients, as predicted by the International Diabetes Federation (IDF).

ACLF is a condition characterized by acute hepatic decompensation in patients with chronic liver disease. It is accompanied by multi-organ failure and a profound systemic inflammatory response. Non-manageable organ damage and secondary infections account for poor short-term survival with 30-day lethality rates of up to 77%, depending on the number of extrahepatic organ failures. ACLF requires intensive care and, in most cases, liver transplantation is the only effective treatment option. However, it is limited by the paucity of donor organs.

Patients with limbal stem cell deficiency face a life of blindness. We are developing a stem cell-based drug which could potentially restore sight.

Limbal stem cells (LSCs) are crucial for the regular physiological regeneration of the transparent, anterior section of the human eye, i.e. the corneal epithelium. Damage to the limbus, the area forming the border between the cornea and sclera, may cause a lack of LSCs leading to LSCD. Typical symptoms of LSCD include corneal conjunctivalization, neovascularization and scarring as well as chronic ocular inflammation. This contributes to loss of corneal transparency, possibly culminating in profound visual impairment or even blindness.

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