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.
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