Tiscover is autologous full thickness cultured skin for healing of chronic, therapy resistant wounds.
Tiscover is an Advanced Tissue Medicinal Product (EU guideline in Regulation (EC) No 1394/2007). Tiscover is classified (by EMA) as a Tissue Engineered Product (TEP).
Tiscover consists of a dermal and epidermal layer, just like normal healthy skin. The interaction of the autologous dermal and epidermal cells ensure a secure secretion of chemokines, growth factors and cytokines into the non healing wound bed. Wound re-activation and reepithelialization occurs through the direct secretion and cover of the wound bed. Tiscover is constructed from 3mm punch biopsies in 3-week culture time.
Multicenter randomized clinical trial
Tiscover is currently in a phase II multicenter trial entitled: “A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated in an outpatient setting with an autologous cultured human living skin substitute (Tiscover®:
test group) or with Acellular donor dermis (AS210: control group) to determine the safety
and relative efficacy of both products”.
Dutch registration CCMO: NL32502.000.11, Eudractnummer 2010-021797-10
· Presence of confirmed venous, arterio-venous leg/foot ulcer.
· Patients age over 18 years.
· Ulcer duration over 12 weeks and less than 15 years consecutively
· Ulcer is between 1-40 cm2 in size
· ABI ≥ 0.6 and ≤ 1.3
· (Legally) capable to give IC and able to comply with requirements of study protocol
· Presence of deep vein trombosis or contra indication for compression therapy
· Severe co-morbidity reducing life expectance to < 1 year · Use of oral corticosteroids and/or cytostatics >20 mg/per day;
· Allergies to Gentamycin (which is used in the tissue media), the used local wound
· Severe infection of ulcer, active cellulitis, osteomyelitis
· diabetic foot ulcer; Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
· Severe malnutrition; Anaemia Hb
For more information see Tiscover on clinicaltrials.gov
Since 2013 A-SKIN has a granted a Hospital Exemption license of The Dutch Health Care Inspectorate (IGZ). Tiscover can be applied for clinical use to patients with a chronic ulcer. The Tiscover treatment costs are not covered by the health care provider (in Dutch: zorgverzekeraar).
Interested, more information: please contact A-SKIN.
A short illustrative movie on “Essence of autologous skin construct Tiscover®.
Application autologous skin construct, Tiscover.