Cellular Therapies Division

The Cellular Therapies Division (CTD) provides comprehensive laboratory support for bone marrow and stem cell transplant patients at Cincinnati Children's Hospital Medical Center, The Jewish Hospital Blood and Marrow Transplant Program, and Akron Children's Hospital, Ohio (Akron Ohio), as well as for the National Marrow Donor Program (NMDP). The hospital transplant service sites perform approximately 200 transplants annually.

CTD provides peripheral blood stem cell apheresis collections, and a large array of processing and cryopreservation services, In addition, CTD assists in the development of novel cellular therapy products and performs innovative cell selection and depletion procedures on hematopoietic progenitor cell grafts and other cellular materials for clinical trial use.

The Cellular Therapies Laboratory is registered with the U S Food and Drug Administration (FDA) and accredited by The Foundation for the Accreditation of Cellular Therapy (FACT) and the AABB. Services are provided in compliance with FDA’s cGTP (21CFR-1271) and cGMP ( 21CFR-211) regulations, as applicable.

CTD has developed and utilizes manufacturing procedures that ensure optimal product safety and allow for extensive product tracking throughout each phase of collection, processing, storage and delivery. CTD also has extensive storage capacity and emergency backup procedures that safeguard the storage of processed stem cells indefinitely. A contractual arrangement between Hoxworth Blood Center and the patient's hospital, and a physician's order are required to receive these services.

CTD, as part of Hoxworth Blood Center, University of Cincinnati Academic Health Center also participates in the laboratory and clinical training of clinical laboratory and research scientists in the field of hematopoietic stem cell transplantation.

The end result is that CTD provides a FDA-compliant, technologically “cutting-edge” operation and facilities that provide our customers with confidence that their patients’ products are manufactured in a safe, secure environment and available at a moment's notice.

Cell Therapy Laboratory Services:

CTD Cell Processing Services

Cryopreservation
RBC depletion
Plasma depletion
CD3 Depletion
Buffy Coat Preparation
CD34 Selection
CD3 depletion
Donor lymphocytes
Pancreatic Islet Cell Isolation
Cord Blood Thaw / Wash
Liquid nitrogen storage
Transportation
Thaw / Infusion

Graft Characterization Services

The Cell Therapy Laboratory either provides the desired quality control testing in-house, or maintains contractual relationships with several laboratories on campus at the University of Cincinnati to provide the patients’ physician with an understanding of the quality of the graft collected for their patients. Available information and testing includes:

Volume
Total cell count
Automated differential
Progenitor cell viability
Sterility testing
CD 34+ cell enumeration
CD 3+ cell enumeration
Colony Forming Unit (CFU) Assays
Endotoxin analysis
Gram stain

Clinical Trial Protocols:

CTD is on the leading edge in regards to clinical trial protocol development. To review the clinical trials that CTD is currently supporting at institutions throughout the Cincinnati area, please click here.

CTD would be pleased to provide assistance with additional Phase I / II cellular therapy clinical trials. The range of services provided can vary to match the Investigator’s needs and includes, but is not limited to:

Process Development / scale up
Production of clinical trial test materials
Distribution of clinical trial test material
Quality control testing
Process / Equipment / Facility Validation
IND applications (CMC section)

Contact Tom Leemhuis for further information.

Education:

Hoxworth Blood Center, through the College of Allied Health Sciences, Department of Analytical and Diagnostic Sciences, offers an 18-month graduate program leading to a Masters of Science degree in Transfusion and Transplantation Sciences.
Click here for more information.

Contact Information:

Cell Therapy Laboratory
(513) 558-1551
cell.therapy@uc.edu

Thomas Leemhuis, Ph.D.
Division Director for Cellular Therapies.

Jose Cancelas, MD, Ph.D.
Medical Director

Staff Members:

Christopher Bruns, Mark Kleiner, Sarah Blocher, Stacy Bush, Frank Petrola, Heather Taggert

Updated: 11/13/09