apceth’s First-In-Man, First-In-Class Clinical Trial with MSCs is Now Enrolling
News Jan 27, 2014
As a world first, apceth has announced that the TREAT ME Phase I/II clinical trial for patients suffering from advanced adenocarcinoma of the gastro-intestinal tract has commenced. This is the first clinical trial world-wide with genetically-modified mesenchymal stromal cells (MSCs).
This innovative next-generation MSC therapy is based on cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient.
The cells specifically target the tumor, or its metastases, where the cytotoxic gene product is selectively activated, increasing local efficacy with reduced systemic toxicity, one of the main problems of systemic chemotherapy.
This unique principle is also applicable to other cancer types. apceth intends to advance this treatment to an off-the-shelf product where cells obtained for healthy donors will be used to treat multiple patients.
“This is an important milestone for all of us at apceth who strive to produce truly innovative products that make a real difference to patients” said apceth’s CEO, Dr Christine Guenther.
Dr Guenther continued, “We are the first to use next-generation MSC-based therapies in the clinic and this sets us apart from the competition. This is a platform technology that carries significant potential and represents the future of cell therapies”.
A human pluripotent stem cell line has been engineered which contains two ‘suicide genes’ that induce cell death in all but the desired insulin-producing cells. This double fail-safe approach opens the door to creating safe cell-replacement therapies for people living with type 1 diabetes.READ MORE