Could a tissue bank of fresh, vital human tissue promote translational research, speed up drug development, and reduce animal testing? The VitalTissue.nl initiative thinks that it can, calling for research into whether a ‘supply chain’ of vital human tissue would be feasible, and what would be required for its successful implementation in the Netherlands.

VitalTissue.nl is an initiative to make residual human tissue available for research purposes. The underlying idea is that setting up a national supply chain for hospital-derived human tissue would enable more rapid development of improved products and drugs. “There have been some initiatives for the wider application of human tissue in the past, so the interest is there – but none of these initiatives ever really got off the ground,” explains Cyrille Krul, director of Predictive Health Technologies at TNO. The reasons for this included the limited availability of tissue, the lack of a national supply chain for fresh, vital human tissue, and uncertainty about the legal and ethical frameworks.

Replacing animal tests

Scientific research and studies to ascertain the safety and efficacy of new drugs, etc. continue to make use of animal testing. Human tissue is only used on a small scale, even though tests using human tissue are expected to yield research results that translate better into drug safety and efficacy for human patients than do the research results of animal tests. In other words: human tissue can speed up research and drug development, deliver more strongly predictive results, reduce drug side effects, and reduce animal testing. “There are more than enough arguments to re-examine the possibility of setting up a supply chain for vital human tissue,” says Krul.

“It is a great pity that material is available but not used”

Availability of healthy tissue

In hospitals human tissue, such as pieces of skin or gut, are removed from patients for diagnostic purposes. However, a tissue sample also includes ‘healthy’ tissue that is not used for the diagnosis. In theory this tissue could be used in research, and it would be of great value if it were to be made available. “The exchange of human tissue is already taking place on a small scale, on the basis of personal contacts between doctors and researchers within academic hospitals or with local companies or research groups. Researchers working elsewhere do not have this access. It is a great pity that material is available but not used. Patients – and society as a whole – would benefit from the exchange of human tissue on a larger scale and the use of more efficient methods,” suggests Krul.

Feasibility study

To assess the need for and interest in this initiative, a qualitative research study was carried out amongst stakeholders including research scientists, doctors, patient organizations and companies. This study showed that there was, indeed, a strong public interest in and research need for vital human tissue samples. The findings are described in the white paper Vital Tissue: A fresh human tissue supply chain to enable translational research, which can be downloaded below this article. “In this paper we urge that a multifaceted feasibility study be carried out,” explains Krul.

“The Longfonds could play a promotional role by increasing patient understanding of the issues”

Win-win situation

The aspects that need to be examined are the identification and matching of suppliers and users; tissue material quality control, logistics and transport; legal and ethical implications; patient cooperation and ‘informed consent’; and the privacy and security of personal data. Krul: “Some of the questions that need to be answered are: is it technically possible to transport a tissue sample so that it arrives in a vital state? How do we ensure that patients are willing to donate tissue? And how should the supply chain be set up so as to minimize inconvenience to patients, suppliers and researchers – perhaps by making use of an online platform. There are issues in all of these areas, but we are also seeing momentum build. If we work together now, we can create a win-win situation for all concerned. The first thing we need is the money to make a start.” The principal challenge will be to work out how a platform for vital human tissue can be successfully set up. It is important that its implementation ties in well with the working methods already used by doctors and pathologists, for instance. “The system needs to be as simple as possible, so we have to think very carefully about its design,” notes Krul.

Promotional role

Not just suppliers, but also patients and patient organizations are being brought into the process. “As a patient organization we are keen to be involved,” says Hendrien Witte, director of the Longfonds (Lung Foundation) patient association. “We think it’s important that research results deliver real benefits to patients. The Longfonds could play a promotional role by increasing patient understanding of the issues, and providing information about why it’s important to give permission for a tissue sample to be used. I don’t know whether patients would be willing to donate tissue for research purposes. My guess is that many would be happy to do so as long as they were given a satisfactory explanation and suffered no discomfort. The subject certainly deserves to be an important part of a feasibility study.”

Who wants to join us?

Krul concludes with a general appeal for cooperation. “Who wants to join us? If we want to do a feasibility study and eventually set up a supply chain, then all parties involved should get behind this initiative.”