Cellular Therapies Division

The mission of the Cellular Therapy Division at Hoxworth Blood Center, University of Cincinnati is to:

Provide exceptional cell processing service to our clinical site customers within the hematopoietic stem cell/bone marrow transplant programs at Cincinnati Children's Hospital Medical Center, The Jewish Hospital Blood and Marrow Transplant Program, or Akron Children's Hospital, Ohio, in Akron, Ohio. The Cell Therapy Laboratory supports more than 200 transplants per year between these institutions.
Facilitate implementation of cellular therapy-based clinical trials throughout the Cincinnati area by producing and testing the clinical trial test material in a highly controlled manner that meets FDA regulations.
Educate laboratory technologists and research scientists in the laboratory aspects of hematopoietic stem cell transplantation.

Cell Therapy Laboratory Services:

Stem cell transplantation is used to replace diseased bone marrow, as in leukemia, or as a rescue therapy for patients undergoing high-dose chemotherapy and/or radiotherapy. Bone marrow or peripheral blood hematopoietic stem cells are collected for patients scheduled to undergo stem cell (bone marrow) transplantation.

For autologous transplants, the patient donates his or her own cells. For allogeneic transplants, a healthy donor provides cells for a patient. Collected cells are processed to concentrate the stem cells, or may be further processed in a variety of ways depending upon the source and volume of stem cells and the diagnosis of the recipient. A cryoprotectant chemical mixture is added to protect cells during freezing and they are cryopreserved and stored at temperatures below -160oC until thawed for infusion into the patient.

The Cellular Therapy Division provides comprehensive laboratory support for bone marrow and stem cell transplant patients at CCHMC, Jewish Hospital, Kenwood and Akron Children’s Hospital, as well as for National Marrow Donor Program (NMDP). Our program provides peripheral blood stem cell apheresis collections, and a large array of processing and cryopreservation services, as outlined below.

In addition, this group 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 Cell Therapy Laboratory’s extensive storage capacity and emergency backup procedures safeguard the storage of cells indefinitely. Tracking procedures employed throughout each phase of collection, processing, storage and delivery provide physicians with confidence that their patients’ products are secure and available at a moment's notice.

A contractual arrangement between Hoxworth Blood Center, the patient's hospital and a physician's order are required to receive these services.

Cell Processing

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

Graft Characterization

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 testing includes:

Volume
Total cell count
Automated differential
Manual differential
Viability
Sterility
CD 34+ cell enumeration
CD 3+ cell enumeration
Colony Forming Unit (CFU) Assays
Endotoxin
Gram stain

Clinical Trial Protocols:

The Cellular Therapy Division at Hoxworth Blood Center is currently supporting the following clinical trials being conducted at institutions throughout Cincinnati:

Non-Genoidentical Donor Stem Cell Transplantation for Fanconi Anemia. (Dr. Davies; CCHMC)
Post-Transplant CD34+ Stem Cell Infusion to Augment Graft Function in Children with Primary Immunodeficiency Diseases. (Dr.Filipovich,; CCHMC)
Collection of Cord Blood for Future Autologous Use and Research in Gene Transfer for Inherited Disorders of Hematopoietic Stem Cells. (Dr. Malik; CCHMC)
A Phase II, multi-center, placebo-controlled study to evaluate the safety and efficacy of PROCHYMAL® (ex vivo cultured adult human mesenchymal stem cells) following acute myocardial infarction. (Dr. Keriakis; Christ Hospital).
Non-Genoidentical Donor Stem Cell Transplantation for Fanconi Anemia: Good Risk Regimen: Cord Blood. (Dr. Davies; CCHMC).
High Dose Chemotherapy with Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors (Dr. Jodele; CCHMC)
A Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients with Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction with Busulfan, Cyclophosphasmide and Fludarabine. (Dr. Davies, CCHMC)

We 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:

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

Accreditation

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

Contact Information

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