Dresden, 13 January 2014: MukoCell GmbH has received authorisation to distribute its product MukoCell® pursuant to Section 4b of the Medicinal Products Act (AMG) – „Special provisions governing advanced therapy medicinal products“. This tissue engineering product, which bears the authorisation number PEI.A.11491.01.1, is thus authorised for distribution in Germany.
MukoCell® is therefore the world’s first tissue engineering product for use in the field of urology with national authorisation.
MukoCell GmbH is a pharmaceutical company that has developed an innovative and gentle method for the surgical repair of urethral strictures and hypospadias. Using an autologous cell transplant (MukoCell®), the patient’s own cells are used for the treatment of urological disease. The replacement tissue, which emerged from the company’s own research and development work, is the world’s first tissue engineering product in the field of urology that is based on the patient’s own cells.
MukoCell® grafts have already been successfully implanted in 100 patients at 10 specialised medical centres in Germany.
Compared to the use of the patient’s own oral mucosa segments, the use of autologous tissue engineered grafts offers distinct advantages to patients: the conventional large-scale removal of oral mucosa is no longer necessary, which means that patients also avoid the complications associated with this procedure. These include pain, bleeding and scarring, which have long-term side effects on salivation, facial expressions, food intake and flexibility of the lower lip. This method also shortens the duration of the operation and the amount of time the patient is under anaesthesia.
To make the graft, a biopsy is performed to extract a small amount of tissue from the patient’s mouth. Within a period of three weeks, this is then used in a cleanroom laboratory to cultivate the tissue replacement of the required size in accordance with GMP standards. The patient’s tissue replacement is then placed into a sterile container and shipped to the clinic for the transplant.
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