Collection of PBMC from Healthy Donors by Leukapheresis for biobanking

• Research type

  Research Tissue Bank

• IRAS ID

  241036

• Research summary

  The biobank will be held at TC BioPharm under Manufacturer's Authorisation: MIA (IMP) 42803.

• REC name

  West of Scotland REC 3

• REC reference

  18/WS/0009

• Date of REC Opinion

  21 Feb 2018

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  Blood and urine samples will be collected during the study. The blood and urine samples collected for routine safety tests will be sent to a central laboratory to be analysed and the Study Doctor will be informed of the results. The collected white blood cell samples will be sent to TC BioPharm Ltd. The samples will be identified by a code number and not by name and therefore it will not be possible for anyone other than the Study Doctor or other authorised staff at the Unit to find out who the sample is from. Blood and urine samples collected for routine safety tests will be destroyed after they have been analysed.
  Stored samples will be coded throughout the sample storage and analysis process and will not be labelled with personal identifiers. Participants may withdraw their consent for their samples to be stored for research.

  Participants will be asked to give consent before blood is stored for future research. Participants are allowed to say no to blood being stored for future research, and may withdraw consent for blood to be stored for research at any time. Stored blood samples will then be destroyed. Participants will be informed if testing on their samples for this study will change.

  Before participation in the study, the written informed consent form will be signed and dated personally by the participant and by the person who conducted the informed consent discussion (investigator or designee). The participant will receive a copy of the signed and dated informed consent form and a copy will be retained by
  PAREXEL. As part of the consent process, each participant must consent to direct access to his/her medical records for study related monitoring, auditing, IEC review and regulatory inspection.

• Research programme

  The bank will support research programme under European Commission – Horizon2020 – Research and Innovation Framework (H2020-SMEINST-2-2016-201, funding scheme SME-2, proposal number 756360) titled: ‘Manufacturing and testing of OmnImmune, an allogeneic gamma delta T cell therapy for the treatment of cancer and viral infections’. TC BioPharm aim to manufacture OmnImmune® - an allogeneic cell bank of cytotoxic gamma delta (GD) T cells, capable of treating primarily patients with cancer. Evolving from a regulatory-approved bespoke autologous treatment to an off-the shelf product, this represents an innovative cell therapy and provides opportunity to treat many more cancer patients and those with infectious disease. This product exposes a significant market previously unable to be targeted with autologous white blood cell therapy. The goals are to (i) manufacture an MHRA-approved allogeneic white blood cell advanced therapy medicinal product- OmnImmune®, (ii) generate phase I clinical data. TC BioPharm is presently conducting an MHRA-approved trial of autologous GD T cell therapy with a GMP-compliant cell expansion method. Leveraging this in-house experience from treating melanoma, renal cell carcinoma and non-small cell lung cancer, output from this project would be a safe allogeneic cell therapy with the potential to treat a variety of cancers and viral infections.

• Storage license

  11042

• RTBTitle

  The biobank will be held at TC BioPharm under Manufacturer's Authorisation: MIA (IMP) 42803.

• Establishment organisation

  TC BioPharm Ltd.

• Establishment organisation address

  Maxim 1, 2 Parklands Way,

  Holytown,

  Motherwell

  ML1 4WR