Orgenesis, a developer of advanced cell therapies, manufacturer and service provider, has entered into a Master Service and Joint Venture Agreement with TheraCell Advanced Biotechnology for the clinical development and commercialization of cell and gene therapies. The JV will implement Orgenesis’ point-of-care (POCare) cell therapy strategy with a goal to bring Advanced Therapy Medicinal Products (ATMPs) to patients at the therapeutic setting by leveraging Orgenesis’ and TheraCell’s combined technical, regulatory and commercial expertise in Greece, Cyprus, Balkan region and Turkey.
 
Under the Master Service Agreement, Orgenesis will provide regulatory consultancy services, pre-clinical studies, intellectual property (IP) services including IP life cycle management, and POCare services including training and technical runs, quality management systems and operational support.
 
TheraCell is a regenerative biotechnology company with operations in Greece, where its laboratories and primary facilities are located. The company focuses in the areas of autologous cell therapy and regenerative medicine.  heraCell has extensive experience in the isolation, processing and application of adipose derived stem cells (ADSCs), as well as somatic cells and has developed a patented platform for tissue engineering and cell therapies in the areas of dermatology, chondral defects and chronic kidney injury.
 
“We are delighted to partner with Orgenesis, as they bring extensive clinical, regulatory and manufacturing capabilities, along with unique IP that will support the development, and ultimately commercialization of this advanced cell therapy,” said Fotis Sakellaridis, chief executive officer, TheraCell. “CKD is a prevalent condition that is associated with high cardiovascular mortality and can progress towards end-stage renal diseases requiring renal replacement therapy. We look forward to collaborating with Orgenesis to advance this therapy, which holds the potential to save many lives.”
 
Vered Caplan, chief executive officer, Orgenesis, said, “TheraCell is an innovator and pioneer in the fields of cell therapy and regenerative medicine. We are pleased to partner with them on this project focused on kidney regeneration, and by our joint venture partnership, our goal is to advance this breakthrough technology through the clinic and into commercialization. ADSCs, being multipotent cells, have numerous therapeutic benefits, given their ability to self-renew and differentiate. Multiple preclinical studies have demonstrated that the administration of exogenous ADSCs holds the potential to prevent progression of renal injury and promote renal recovery. We look forward to leveraging our cell therapy platform in order to accelerate their timeline of bringing this innovative treatment to market.”