1. Core description:

Although islet transplantation has become a clinical and experimental reality, the challenge to investigators has been that human pancreatic tissue processing is a very complex, highly specialized and costly procedure that requires technical expertise and a properly equipped facility. This Core provides FDA approved human islets for use in clinical islet transplant trials and provides human and mouse islets to investigators working on basic and applied research projects. This Core takes advantage of several islet production facilities. The UCSF?s Islet and Cellular Production Facility, a facility dedicated to the manufacture of biological products under FDA?s cGMP regulations, produces human islets for transplantation and experimentation. A rodent islet procedure room located within the University of California-San Francisco?s Diabetes Center processes murine islets. The Core Director and staff have extensive experience in mouse, rat, and human islet isolation, islet purification, islet culture and islet quality control, having processed several hundred rodent preparations and greater than forty human pancreases for islets.

Standard Operating procedures have been developed for all steps in the preparation of human islets for transplantation and batch product release criteria have been defined. The Core has standardized islet isolation techniques so that successive batches of islets function in a reproducible fashion. The Islet Production Facility Core has established sophisticated assays such as measurements of insulin biosynthesis, intracellular calcium, NADPH, ATP, and glucose oxidation as part of an extended islet quality control.

2. Services provided:

Islet Production: The core provides to all DERC investigators high quality islets from human and murine islets. Islet isolation and purification is very difficult and labor intensive process. The ability of an individual investigator interested in studying pancreatic islets or b-cells to assemble, support, and maintain an islet isolation laboratory would be a costly and a major undertaking. This Core has organized all islet core technician time, organizes and orders all reagents necessary for islet isolation for all species studied, and tests and prepares all reagents necessary for islet isolation and processing.

Islet Assessment: The core can assesses a number of biological and biochemical attributes of the islets provided including, insulin secretion, purity, sterility and ability to reverse diabetes in immune compromised mice in order to assure quality product has been prepared for DERC investigators.

3. Equipment available:

The UCSF Islet and Cellular Production Facility (ICPF) occupies 4,500-sq. ft. total laboratory and office space on the sixth floor of the Mission Center Building. The 4,500 square foot Human islet isolation facility is dedicated to the manufacture of biological products under the cGMP regulations and is operated by the University of California-San Francisco?s Diabetes Center. The UCSF ICPF?s clean room suite A is used solely for the processing of islet cells, the facility consists of three clean room suites, a sterile staging area, a gowning room, and quarantine and materials release room. The clean room suites are designed to meet Class 100,000 (Federal Standard 209E) as a minimum. Clean room suites A and C are at the highest relative pressure while Suite B was designed to be at negative pressure to the facility so to be utilized as a potential virus vector suite. All processes involving an open system are performed in biological safety cabinets (four per clean room). Each cabinet is a 4ft. or a 6ft., Class II, vertical laminar flow with high capacity, low resistance HEPA filters that provide 99.999% particulate removal of 0.3 micron size. All areas are supplied by one pass HEPA filtered air. The rooms are also constructed to provide for unidirectional flow for both personnel and materials. Materials enter the space via a pass through from the released materials area to the staging area while people enter through the gowning room to the staging room and then enter the clean room suites.

The UCSF Diabetes Center Rodent Isolation Facility. This facility is located in the Medical Research building within the rodent barrier facility. The facility is a 300-sq. ft. rodent procedure room dedicated to the isolation of murine islets. It houses a 6-ft. horizontal laminar flow hood, a CO2 Incubator, refrigerator, freezer, microscopes, anesthesia machine, a 70-cage ventilated mouse rack, which provides HEPA filtered air to all the cages in the rack, and all the necessary equipment to isolate and purify rodent islets. This room houses all mice transplanted with purified islets from multiple species. The staff is well trained at isolating, purifying murine islets and in the transplantation of the mouse and human islets.

4. Pricing:

Download the Information and Usage Form.

The Core will not charge for the operation of core equipment or personnel as it is our experience that recharges inhibit the application of the equipment for high-risk experiments. Users will be charged for animal purchase cost and per diems and cost of enzyme, density gradients, media and other materials, not including personnel costs.

5. Information on recharge arrangements:

Development of a recharge system is currently underway

6. Contact information:

Greg Szot
Diabetes Center at UCSF
HSW Rm 1118
513 Parnassus Ave. Box 0540
San Francisco, CA, 94143

glszot@diabetes.ucsf.edu
Work Phone 415-514-2108

7. Hours of operation:

M-F 9:00AM-4:00PM

Special arrangements can be made for after hours and human islet procurement.