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National Disease Research Interchange Advancing Medical Research Through Organ and Tissue Donation.

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Presentation on theme: "National Disease Research Interchange Advancing Medical Research Through Organ and Tissue Donation."— Presentation transcript:

1 National Disease Research Interchange Advancing Medical Research Through Organ and Tissue Donation

2 History & Overview

3 NDRI Mission Statement To advance disease research through the procurement, preservation and distribution of human cells, tissues and organs.

4 NDRI Founded in 1980 Based in Philadelphia 501(c)(3) Governed by BOD Operates 7 days a week, 24 hours a day Served more than 5,000 investigators with over 300,000 biospecimens Funded by the NIH for thirty-plus consecutive years 2,700 publications

5 Funded by National Institutes of Health for 30 Years NIH Office of the Director (ORIP, GTEx) NIMH NHGRI NCI NIDDK NIAID NEI ORDR NIAMS NHLBI

6 Other Funding Streams Corporate Pharma/biotech industry Provided tissues to > 330 for-profit entities in last 5 years Special Initiatives Cystic Fibrosis Foundation Collaboration Genotype-Tissue Expression Project ATSDR/Boston VA ALS Projects Joslin Medalist Diabetes Project Children’s Tumor Foundation

7 Types of Tissue Requests Standard Requests Eyes Solid organs Tissue bank specimens Surgical specimens Custom Project Requests Specialized sourcing Special initiatives o Eye sections o Dorsal root ganglia o GTEx o ALS (VA, ATSDR)

8 NDRI Reach & Network

9 NDRI Procurement Network 56 Organ Procurement Organizations 240 Sites 46 Hospital Donor Sites 18 Satellite Tissue Source Sites 37 Eye Banks 23 Tissue Banks 200 Recovery Personnel

10 Biospecimen Diversity Normal Diseased – common and rare High quality, low-PMI organs and tissues Brain/CNS Cancer /normal adjacent Cord blood/placenta/umbilical cord Isolated normal /T1D/T2D pancreatic islet cells

11 Versatility of Human Tissue in Research Viable, shipped at 4ºC Stem cell isolation Regenerative medicine Cell culture Functional analysis Single cell analysis High throughput screening Toxicology/DMPK Snap-frozen/fixed Expression analysis Genotyping IHC Proteomics Biomarkers Biomechanics

12 Functional Analysis

13 Project Examples

14 Genotype Tissue Expression Project (GTEX) 5 year project - August 2010 to 2015 400 post mortem donors consented and recovered –69% authorization rate PMI range 1:22 to 6:51 (O), 7:01 to 24:00 (T) 44,341 biospecimens collected 96% released to NIH CaHuB inventory 84% RNA integrity number > 6

15 GTEx Post-mortem Organs and Tissues Skeletal muscle Tibial nerve Tibial artery Skin (leg) Adipose tissue Whole brain Brain tissues (cerebellum and cortex) Pituitary gland Thyroid gland Minor salivary gland Skin (suprapubic region) Heart (left anterior ventricle, right atrial appendage, coronary artery and aorta) Greater omentum Mammary tissue (male and female) Lung Stomach Esophagus (mucosa and muscularis propria) Gastroesophageal junction Liver Spleen Pancreas Colon (transverse and sigmoid) Lymphoid tissue of terminal ileum Kidney (cortex) Adrenal glands Female (uterus, ovary and vagina) Male (prostate gland and testes)

16 GTEx Biospecimen Source Site Comparisons Colon Line : Y = -0.18796*X + 7.89886 Pearson correlation: r = -0.722165 t-score = -10.543999

17 Cystic Fibrosis Explanted lungs recovered from CF patients undergoing transplant NDRI provided ~200 CF lungs for Cystic Fibrosis Foundation-funded project Two new drugs developed Type 1 Diabetes Pancreas, kidney, eyes recovered from long-standing T1D patients Nationwide recoveries using NDRI Private Donor Program

18 Amyotrophic Lateral Sclerosis Two projects funded by ATSDR/McKing Corp – 30 patients targeted for recovery Boston VA – 200 patients registered Patients identified and consented by collaborators Nationwide recoveries using NDRI Private Donor Program o Collects brain, spinal cord, CSF, bone & skin o Recoveries completed < 24 hours post mortem

19 NDRI Research Services

20 Biospecimen Application Process Application –Tissue needs/donor profile –IRB documentation –Project synopsis –CV/biosketch Feasibility review – internal/external Customized protocol development

21 Standard Authorization/Consent Protocol approved by Univ. of Pennsylvania IRB Risk mitigation a priority Authorization for general research including o For profit o Therapeutics and diagnostics o Genome sequencing Potential access to complete health record No payment to donor or family decision maker

22 Customized Authorization/Consent Project specific IRB approval Incorporates additional objectives (e.g. product development) Right to withdraw limits Addresses risks associated with loss of identity (genotyping) Unknown future uses Cell line development (unlimited future use)

23 Summary Project-driven services to scientists Nationwide collection centers Worldwide distribution capabilities Diseased and normal biospecimens available from multiple donor types SOPs and total QMS in place for consent, recovery, & distribution

24 Acknowledgements


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