The Hematopoietic Stem Cell Laboratory (HSCLab) provides production assistance for cellular therapies in a facility located on the first floor of the Hillman Cancer Center. The HSCLab was founded in 1991 in Montefiore University Hospital and moved to its current location in the Hillman Cancer Center in 2003. Its primary mission is to support the Hematopoietic Stem Cell Transplant Program, but also serves as a production facility and reference lab for other programs and institutions. Albert Donnenberg, PhD, has directed the HSCLab since 1997, and Joseph Kiss has served as the Medical Director since 2000.
The staff processes, cryopreserves and assists in the infusion of hematopoietic progenitor cell products, therapeutic T-cell products and a variety of other non-hematopoietic cellular products. The HSCLab also provides expertise in the application of current Good Manufacturing Practice (cGMP) to human cell and tissue products, and assistance in the translational development of cellular therapies. Together with its sister laboratory located at UPMC Children’s Hospital of Pittsburgh, they have implemented a wide range of innovative clinical protocols, including:
- Adoptive immunotherapy for breast cancer: MUC-1 vaccine plus autologous transplant with infusion of MUC-1 sensitized autologous cells
- Radically T-depleted autologous hematopoietic stem cells for reconstitution after immunoablative therapy for severe systemic sclerosis and Crohn’s disease
- Selected CD34+ bone marrow cells for cardiac repair
- Selected CD34+ peripheral stem cells for cardiac repair
- Donor-derived mobilized hematopoietic stem cells for promotion of chimerism and tolerance in directed donor liver lobe and kidney transplantation
- Cadaveric BM mononuclear cells for promotion of chimerism and tolerance in hand and hand/forelimb transplantation
- Isolated hepatocyte transplantation
- Allogeneic MSC for inflammatory bowel disease
- Allogeneic MSC for graft-versus-host disease
- Ex vivo expanded umbilical cord blood for allogeneic hematopoietic stem cell transplant
- Cell augmented adipose autograft for cranio-facial and amputation stump reconstruction
The state-of-the-art HSCLab is designed with architectural features consistent with FDA recommendations for cleanrooms and controlled environment, similar to a pharmaceutical manufacturing facility. The overall design, air quality systems and architectural finishes meet regulatory requirements and are consistent with the ability to integrate equipment and all utilities into the process of cell manufacture.
The HSCLab is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT), CLIA (#39D0869846) and Pennsylvania Department of Health (#022322), and is registered with the FDA (FEI# 3004565478). It is CAP accredited for flow cytometry, hematology and blood typing.