CellTrans has unique expertise and cGMP facilities to manufacture high-quality human islets with demonstrated efficacy
Allogeneic islet transplant
Despite technological advances in intensive insulin therapy (i.e. pumps, sensors, continuous glucose monitors), patients with brittle type I diabetes may continue to experience hypoglycemic unawareness and life-threatening hypoglycemic episodes. Islet cell transplantation can prevent severe hypoglycemic episodes and improve glycemic control. Allogeneic islet transplantation is safe, effective, and minimally invasive with proven outcomes, fewer complications, and similar overall costs to whole pancreas transplants.
Autologous islet transplant
Patients suffering from chronic pancreatitis can benefit from a partial resection or total pancreatectomy with an autologous islet cell transplant.
Benefits include reduction in exogenous insulin and maintenance of normoglycemia. This complex procedure requires specialized expertise and trained personnel with access to a certified islet isolation facility.
Our state of the art cGMP facility includes:
- Fully Certified ISO 7 and ISO 5 processing areas.
- Over 1,000 sq. ft of support space
- Quality Control Laboratories and Observation Room.
- Bac-T/ALERT 3D Microbial Detection System
Cell Isolation Laboratory
Our cGMP facility is designed to manufacture high-quality pancreatic islets for clinical use. Our dedicated clean room complex includes three rooms of ISO 14644 classified space covering 800 sq. ft. and 1,050 sq. ft. of support space. Manufacturing and support operations consist of Controlled Not Classified (CNC), ISO 8, and ISO 7 areas. The rooms maintained as CNC space include two quality control laboratories, receiving area, observation room, raw material storage, a room to house an automated microbial detection system, and office space for staff.
Quality Control Testing of the final islet product includes the following:
- Identity – Dithizone Islet Stain
- Purity – Endotoxin Quantification
- Potency – Glucose stimulated insulin secretion assay and Islet Quantification