REPROCELL and BioBridge Global sign Memorandum of Understanding to accelerate global manufacturing services using clinical iPSCs

Clinical Trial Support

The clinical research team includes two physicians who are board-certified in transfusion medicine and a PhD-level director with extensive clinical trial experience. 

In total, the team has more than 50 years of combined experience as principal investigator of investigator-initiated and industry-sponsored, IRB-approved protocols. The organization has participated in more than 50 studies with protocols encompassing blood product collection and characterization, device and assay performance assessments for FDA approval.

The CITI-trained clinical research team is experienced in pre-clinical and all phases of clinical trial support and includes a clinical research manager, coordinators, recruiters and phlebotomists.

The team has a growing research donor registry of more than 30,000 discrete registrants managed in a secure clinical trial management system. Donors are recruited for specific criteria from the well-characterized registry. 

After completion of a research informed consent, the team implements custom screening requirements including on-site testing and physical examination in private screening rooms.  At a dedicated collection space, research subjects donate under IRB-approved protocols.


  • Established protocols overseen by a central IRB
  • Implementation of sponsor’s protocols by request
  • Controlled Human Subjects Research policies and procedures
  • Quality management system and electronic batch records
  • Phase I oncology trial for autologous collection of peripheral blood stem cells
  • All of Us Research Program Participant Center for recruiting and biosample collection (NIH longitudinal research)
  • Population screening studies
  • Blood collection tube validation expiration testing studies
  • Blood processing equipment testing
  • Phase I-III clinical trial support

Case Study

A pharmaceutical company developed an autologous immunotherapy for treatment of cancer using a patient’s own immune cells. Partner sites were required to collect the patient’s mononuclear cells through apheresis and ship for further manufacturing into the immunotherapy.

To support the clinical trial, the organization:

  • Qualified as an apheresis collection site for their clinical trial
  • Developed partnerships and communication plans with local hematology/oncology physicians
  • Developed all internal SOPs in accordance with the company’s protocol, in a cGMP compliant manner
  • Reported on clinical trial activity and performed electronic data entry as required by the sponsor to support their FDA submissions 

Since this immunotherapy received FDA approval, South Texas Blood & Tissue has maintained its partnership and continues to provide apheresis collections to support this commercialized therapy for patients in South Texas. The organization collaborated in the creation of a tool for other apheresis centers to improve and enhance collections.

Commitment to Quality
Quality has been a guiding principle within our organization for almost 50 years.
Contact Us
For additional information about our products and services.
View list of U.S. and international accreditations, certifications and registrations.
Close this search box.