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Lab Manual for UCSF Clinical Laboratories

Lab Manual for SFGH

Internal Resources

Pediatric Cellular Therapy Laboratory

Contact Information

Directors

Supervisor

Staff

Pediatric Blood and Marrow Transplant Physicians

Hours of Operation

  • Monday to Friday – 9:00 am to 5:30 pm

Location

  • UCSF Benioff Children’s Hospital San Francisco
  • 1975 4th Street, Room C4C60
  • UCSF Box 4042
  • San Francisco, CA 94158
  • Phone: (415) 476-4860
  • Fax: (415) 514-3372

Overview

The Pediatric Cellular Therapy Laboratory serves the needs of the pediatric patients cared for by the Pediatric Blood and Marrow Transplant Program of UCSF Benioff Children’s Hospital San Francisco and Oakland. As an independent processing facility the laboratory also offer and perform services for outside facilities that needs CD34 selection or T-cell depletion of hematopoietic progenitor cell products. The laboratory processes blood and marrow stem cell collections for fresh infusion, cryopreservation for long term storage for patients who will require a future transplant, cryopreserved cord blood thaw and infusion, RBC depletion for ABO incompatible donors, CD34 Selection and T-cell Depletion by Clinimacs. The laboratory processes over 150 blood and marrow stem cell collections each year, including autologous, related allogeneic, unrelated allogeneic, and cord blood units.

The Pediatric Cellular Therapy Laboratory is an accredited Independent Processing Facility by the Foundation for the Accreditation of Cellular Therapy, registered with FDA, accredited by the Joint Commission and licensed by the California department of Health Services for both Biologics Manufacturing and Tissue Banking.

The facility is divided into two areas: Clean Room Area which is operated as an ISO 7 class facility and Ambient Area which is operated as an ISO 10 class facility. The Clean Room Area consists of the following rooms: 1st Stage Gowning Area, 2nd Stage Gowning Area, Preparation Room, Flow Cytometry Room, Processing Room 1 & 2 and Cryogenic Freezing Room. The Ambient Area consists of the following rooms: Lab Tech Offices and Ambient Storage Room.

The laboratory is monitored 24 hours by our Vaisala Veriteq Environmental Monitoring System which monitors temperature, humidity, CO2, liquid nitrogen level, supply tank condition and room differential pressure and automatically notify proper personnel if any of the parameters are outside of the threshold level. Access to the laboratory and respective rooms is by proximity badge reader and restricted to registered personnel only.

Service Name Location

HPC, Apheresis and HPC, Marrow Processing

  • Autologous Donation
  • Related Allogeneic Donation
  • Unrelated Allogeneic Donation
Mission Bay

Cryopreservation and Long Term Storage of HPC Products

  • Standard storage of 5 years from the time of cryopreservation.
Mission Bay

Stem and Progenitor Cell Infusion

  • Fresh HPC Infusion
  • Thawed HPC Infusion
  • Hematopoietic Cell Boost / Rescue
Mission Bay

CD34 Selection or T-cell Depletion

  • Clinimacs Plus
  • Clinimacs Prodigy
Mission Bay

Gene Therapy for XSCID and Artemis-SCID

T-cell alpha & beta depletion

  • (Validation Stage – Call the laboratory for details)
Mission Bay

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