CTC Biorepository | Ohio State College of Medicine

The Comprehensive Transplant Center (CTC) Biorepository provides high-quality, clinically annotated normal and diseased human biospecimens for current and future Ohio State University-affiliated research. Our ultimate goal is to enhance human tissue research and precipitate innovative scientific discovery that will result in improved patient treatments and outcomes.

We are a centralized clinical data and biospecimen repository within the CTC, and are supported as a core facility under the Davis Heart and Lung Research Institute (DHLRI). Our biorepository and its Institutional Review Board (IRB)-approved Total Transplant Care Protocol (TTCP; IRB Protocol # 2017H0309) and TTCP Honest Broker Protocol (IRB Protocol # 2017H0309) cover the collection, processing, storage and distribution of human specimens and clinical data from Ohio State transplant patients and from healthy donors through Lifeline of Ohio Organ Procurement Agency.

Patients can participate in Ohio State’s Total Transplant Care Program (TTCP) by donating tissue to the Comprehensive Transplant Center’s Biorepository.

CTC Biorepository

The CTC Biorepository and its IRB protocols function to facilitate efficient specimen and data access to researchers, lower administrative burdens, increase the patient participation rates and ensure the protection of patients and their data, while serving to stimulate human tissue research at OSU. Our hope is this translates into researchers being more competitive for grants and high impact publications that further moves our research institute toward an era of great scientific growth.

Our Goals

Establish a longitudinal clinical and related data repository under the Total Transplant Care Protocol

For pre- or post-transplantation patients, lifetime follow-up information may be collected regarding medical/surgical treatment, laboratory, radiological, pathological and microbiological data and outcomes. These data will be updated with regular reviews of the electronic medical records that are completed as part of patient’s regular clinical care.
Establish a longitudinal repository within the CTC of tissue and fluids from TTCP-consented patients with specific diseases

Samples would be collected at the time of transplant or surgery or in conjunction with regularly scheduled routine clinical care during bronchoscopies, biopsies or follow-up visits. Explant tissue and cells, and, if available, research blood, bronchoalveolar lavage fluid (BALF) and/or biopsies will be collected at the time of transplant and/or during routine clinical care.
Procure biospecimens from control or "normal" organs and tissue, as well as other biospecimens suitable for research

Types of Donors for Biospecimen Procurements

Control Lifeline donors

The central Ohio organ procurement organization Lifeline of Ohio will provide organs and tissues not suitable for transplant, but suitable for research purposes. These tissues can be used by investigators to obtain control samples to which they can compare explant or diseased biospecimens. When Lifeline identifies these organs and tissues, they will call the Biorepository to determine if we can use these organs or tissues. Criteria for accepting donor tissue can be adjusted according to an investigator’s needs. These biospecimens are considered not human subject research as per Office of Responsible Research Practices and, as long as the biospecimens remain unidentified, they do not require investigator IRB approval for distribution.
Transplant or surgical patients

Informed consent to the Total Transplant Care Protocol will be obtained while the patient is under the care of a physician at OSUWMC. All patients who are referred to the OSUWMC Comprehensive Transplant Center will potentially be eligible to participate in this program. The initial recruitment to the study will take place during the transplant candidate evaluation process. For patients who have already undergone a transplant, recruitment will occur at a regularly scheduled clinic visit.

Additional Information

How the data and biospecimens are collected and stored

Clinical and related data of patients will be collected from the time of initial entry into the study and continue for life. Collected specimens would include, but not be limited to, tissues such as normal and diseased lung, liver, pancreas and kidney, as well as biological fluids such as whole blood and blood components (e.g., serum, plasma, buffy coats), bronchoalveolar lavage fluid, saliva and urine, and solid specimens such as feces. In the future, we will broaden the types of tissue collected to expand our services to more Ohio State researchers.

The biorepository will store whole tissue and cells in many preparations (e.g., snap frozen, RNAlater, AllProtect, formalin, cryopreserved), but will also have the expertise to isolate and store cell types of special interest. Collected biospecimens will be processed, preserved, labeled with a unique identification number, bar coded and stored at the CTC Biorepository until distributed to approved investigators. Processed fresh biospecimens can also be distributed to investigators who have prior approval from the IRB (if applicable) and the TTCP Scientific Review Committee.

Biological samples will be collected, processed and stored in accordance with CTC Biorepository’s standard operating procedures that are based on NCI and ISBER Best Practices for Repositories.
Types of specimens collected
Biospecimens are prospectively collected:
- Fresh tissue
- Snap frozen tissue
- Tissue in preservative: RNAlater, AllProtect, formalin
- Tissue in OCT and paraffin
- Single cell suspensions
- Blood components: Plasma/sera and cells
- Non-invasive samples: e.g., lung, liver, kidney biopsies, buccal swabs, oral washings, urine, feces
Please contact us for any other types of samples that may be of interest.
Investigator application for samples

Data and/or biospecimens may be requested for use in an approved protocol with and without PHI. De-identification refers to the process of removing the 18 HIPAA identifiers that allow data, tissue, blood or other biological samples to be identified with a specific patient and assigning a unique identification number instead. To request biospecimens and/or data, investigators must complete the appropriate data/biospecimen request form, biospecimen and data use agreement(s) and provide documentation of an IRB protocol that discusses the use of the samples (if required).

Biospecimens and/or data may be released to researchers following de-identification or proper IRB approval (if required). Investigators who wish to have data or biospecimens with coded or identified data will be asked to secure IRB approval that should be provided with their application. Once the application is received by the Biorepository, ultimate approval of the release of data or biospecimens to investigators will be the responsibility of the TTCP Scientific Review Committee that meets monthly.
Ethics and patient protection

Independent ethical oversight will be maintained using our Total Transplant Care Scientific Advisory Committee and our Total Transplant Care Scientific Review Committee. We’ll also engage the Center for Bioethics to annually review our IRB protocols, consents and processes to ensure we are adhering to legal regulations and ethical requirements, and to ensure IRB compliance.

Additionally, our patient informed consent process and IRB protocols will serve to protect the identification of patients, while still ensuring enough information is available for researchers to generate accurate and rigorous data. In all efforts of the CTC Biorepository, we will adhere to the ethical principles of beneficence, justice and respect for all patients.

Comprehensive Transplant Center Biorepository

Supporting research that may lead to scientific discoveries.

Our Goals

Establish a longitudinal clinical and related data repository under the Total Transplant Care Protocol

Establish a longitudinal repository within the CTC of tissue and fluids from TTCP-consented patients with specific diseases

Procure biospecimens from control or "normal" organs and tissue, as well as other biospecimens suitable for research

Types of Donors for Biospecimen Procurements

Control Lifeline donors

Transplant or surgical patients

Additional Information

How the data and biospecimens are collected and stored

Types of specimens collected

Investigator application for samples

Ethics and patient protection

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