Human Biospecimens

What is an Organ

Organs are organized structures comprised of multiple cell and tissue types that perform specific functions. Examples of organs include heart, lungs, liver, stomach, etc.

A tissue is an organized collection of similar cell types that function together collectively. There are four main types of tissue: epithelial, connective, muscle, and nervous.

Donation for organ and tissue transplantation is a priority over research donation. Organ and tissue donation serves as an opportunity to save or improve the quality of life for recipients. Both transplant and research donation are authorized using the same methods; however, the key difference is that the required eligibility screening used for transplant may not be relevant for research donation particularly if the research requires the presence of disease. LifeNet Health’s research tissue team will work with each researcher to ensure donor eligibility screening requirements meet the project needs.

LifeNet Health offers donor family decision makers the opportunity to authorize post mortem research tissue donation in addition to transplant donation. Our authorization practice provides for a thorough discussion regarding the types of organs and tissues that can be donated and detailed disclosures regarding the permissible uses of the research tissue biospecimen. LifeNet Health conducts and documents the full donation authorization and disclosure process according to the guidance contained within the Uniform Anatomical Gift Act (UAGA), 2006. The UAGA sets the regulatory framework for the donation of organs and tissue in the US. LifeNet Health builds trusting relationships with donor families by keeping them informed about the outcome of their loved ones donation, providing bereavement counseling, and many other services.

• Relevance of human response in predictive drug/chemical models versus animal is critical in disease and safety research
• Translational research is necessary to quickly go from bench to bedside
• US FDA requires the use of certain human cell assays and tissue panels during investigational drug evaluation studies
• Scientific applications focused on researching disease progression
• Evaluation of drug efficacy during drug discovery evaluations
• Understanding toxic responses in humans during experiments to determine drug/chemical safety

LifeNet Health supports diverse research pursuits by building researcher specific project guidelines for donor selection, recovery methods, and preservation. Our Human Biospecimens service is a prospective tissue recovery program that supports a broad range of scientific studies. Organs and tissue biospecimens can be used for single cell studies, organ/tissue construct models, 2D or 3D in vitro models, biomarker discovery, disease progression, as well as non-diseased and disease specific studies. LifeNet Health can build a collaborative biospecimen collection program for most organ and tissue types within the human body.

Common applications include:

• Drug discovery and development
• Disease progression research
• Genomic and proteomics
• Exploration studies
• Non-diseased control tissue
• Biomarker discovery
• 2D and 3D Cell culture
• Normal and high through put cell assays
• In vitro cell models to mimic specific organ and tissue function

Our trained professional staff work carefully with each researcher to generate a research tissue protocol designed to maximize the research tissue quality. We have a five-step process to review human biospecimens requests. The process generally takes two to three weeks to obtain project approval and activation.

1. The application - This step defines the researcher, their organization,  and research project.
2. Feasibility and approval determination
3. Scoping - this step is where we identify and confirm donor criteria, recovery specifications, biospecimen preservation method(s), and transportation logistics.
4. Training of recovery personnel - This step is only necessary if special recovery and preservation methods are required
5. Project Activation - Biospecimen recovery begins

The research tissue protocol provides clear research tissue donor parameters, including recovery and preservation instructions for the donor screening and surgical recovery teams. This is a critical tool used to standardize research tissue recovery and minimize pre-analytic variables. All acute deaths referred to LifeNet Health can be effectively screened according to this protocol. When authorized donor matches occur, the recovery teams will review this information resource for precise research tissue recovery and preservation instructions.

The delivery method is entirely based on the project requirements and the intended applications for the recovered biospecimen(s). Researchers studying viable cells and tissue constructs will require very short warm and cold ischemic times from asystole; therefore, a stat-courier will be employed to deliver the biospecimens in less than 24 hours. Other projects that require formalin fixed and/or frozen tissue can be shipped via overnight shippers like FedEx or UPS.

Prospective research biospecimen recovery offers researchers many advantages. First, the researcher can design specific protocols around donor selection, recovery techniques, preservation methods, and delivery options. These types of recovery programs enable researchers to build exacting instructions to ensure that each recovered biospecimen meets the requirements of the experiment or research program. This customized approach allows for the collection of viable organs and tissues from post mortem donors that are within specific age groups and have the presence or absence of disease and/or treatments. This type of practice is very different than a biobank approach.

Biobanks represent a different approach to human biospecimen collection. Sample are collected using a uniform procedure with little opportunity to customize donor selection, recovery, or preservation methods. Most biobanks preserve samples via fixation and freezing methodologies and focus sample collections on specific diseases like cancer.  

Genotype Tissue Expression (GTEx) Project

LifeNet Health has supported many large scale biospecimen collection programs. One National Institutes of Health project, the Genotype Tissue Expression project, was a multi-year project that required hundreds of samples from each donor. This gene expression project required the collection of more than 25 human tissue types with low post mortem time intervals using a highly skilled staff. The biospecimens were representative of most body systems. LifeNet participated in the early phases of the study and helped define many of the advanced systems necessary to recover organs and tissue in conjunction with organ donation. This multi-institutional collaboration was highly successful due to the participation of almost 1,000 organ and tissue donors.

Uniformed Services University’s Center for Neuroscience and Regenerative Medicine (CNRM)

LifeNet Health was one of the first transplant programs to partner with the Uniformed Services University’s Center for Neuroscience and Regenerative Medicine (CNRM) to screen for, authorize, and recover brain from US military service men/women suspected of having traumatic brain injury (TBI). The CNRM is dedicated to the study of TBI in military service men/women and is the only such repository nationwide. We all recognize the importance of projects that can help us understand the underlying causes of TBI disease and potentially lead to the prevention, approaches for rehabilitation, identification of treatments, diagnosis and reducing long term effects. Since 2015, we have authorized and recovered more than 90 brains.

Frequently Asked Questions:

1. What is considered a standard biospecimen recovery? A standard biospecimen recovery includes biospecimens that can be recovered while transplant tissue is being recovered. This combined with the use of routine preservation techniques allows for research tissue recovery utilizing the same recovery teams used for transplant recovery.
2. Define what a custom biospecimen recovery is comprised of? A custom biospecimen collection project features the collection of multiple tissue types, advanced dissection and preservation methods, and minimal time from death to preservation.
3. What does post mortem interval time mean? Death to preservation interval and includes warm ischemia and cold ischemia.
4. What is warm ischemia? The interval of time from cessation of blood flow to the tissue and when the biospecimen is excised and placed into cold preservation solution.
5. What is cold ischemia? The interval of time from when the biospecimen was placed on ice and when it was received by the researcher.
6. What are common preservation methods? The most common biospecimens preservation methods include freezing or placement into media or fixation solution and immediately shipped to the researcher.
7. What are additional processing requirements? Some preservation methods require more than one step such as a rinse prior to final media preservation, formalin fixed paraffin embedded, or optimal cutting temperature samples. LifeNet Health can accommodate specific researcher requirements and works with the researcher to provide the specific preservation methods necessary for project success.
8. What is an organ/tissue flush? In some instances researchers may require a vascular flush of the organ or tissue. LifeNet has experiences with this technique and can build this into research projects.
9. What types of media are used in solid organ donation? Belzer UW/UW Solution/Viaspan is the gold standard and most common solution to preserve solid organs for transplant. HTK (Histidine-tryptophan-ketoglutarate) Solution or Custodial HTK Solution is also used by several US based organ procurement organizations. Some less expensive alternatives that support research organ and tissue preservation include Lactated Ringers Solution, saline, and DMEM.
10. What is donor eligibility and how do I address this for my research project? There are several factors you will want to consider regarding donor eligibility.
    • What do I need to know about disease? The presence or absence of specific diseases is important for many research projects. When establishing the donor eligibility parameters for any human biospecimen recovery project the requirements need to be very specific and list diseases of interest and diseases that should be excluded.
    • How do co-morbidities impact research? Most post mortem donors have co-morbid diseases. Knowing how these affect the targeted biospecimen is very important when designing a research study using human organs and tissues.
    • How can patient treatment(s) interfere with my study? Many post-mortem donors will have various ongoing treatments at the time of their death. Certain treatments like chemotherapy have systemic affects that can damage the research biospecimen. When working with LifeNet Health to build your donor profile, pay careful attention to how various treatments could impact your project.
    • Should I be careful regarding previous surgeries? Yes, previous surgeries can help in understanding a donor’s health history. As an example, if your project requires a non-diseased heart, you will want to exclude any donor with previous cardiac surgery.