Research Tissue

Research Tissue

Kate Truncale, MS

Senior Scientist

Overview• About MTF

• Why Research Consent is Important

• Research Tissue Avenues

• Examples of Various Research Projects Utilizing Research Tissue

MTF Mission Statement

MTF is a non-profit service organization dedicated to providing quality tissue through a commitment to excellence in education, research,

recovery and care for recipients, donors & their families.

MTF Facts

•MTF was founded by leading academic orthopedic surgeons who identified an increasing need for high quality allograft tissue.

•Since 1987, MTF has recovered over 60,000 donors and have distributed over 3 million grafts.

•In 2007, MTF recovered over 6,300 donors resulting in more than 390,000 grafts to surgeons, hospitals, dentists and clinicians.

Why We Need Research Consent

• Honor & maximize the gift– If donor is non-transplantable and does not

have research consent it can’t be used!

• Improve current tissue forms & processes

• Develop new tissue forms & processes• Broaden applications for tissue forms• Optimize donor criteria

Avenues for Research Tissue

• Internal MTF R&D Projects

• MTF Research Tissue Program (Hospitals& Universities)– Application process

• MTF Research Grant Program– Directed research– Grant applications

Fresh Osteochondral Allografts• Application: Cartilage repair, eliminate pain and

morbidity associated with autologous grafting• Study: Affect of storage media on cell viability

of fresh refrigerated osteochondral allografts for articular cartilage repair

• Result: Proprietary media developed to maintain cell viability, allowing introduction of living chondrocytes to the implant site

Acellular Dermis (Flex HD)• Application: Hernia repair, pelvic floor

reconstruction, urological incontinence, rotator cuff repair

• Study: Develop a process to remove epidermal and dermal cells from donated skin producing acellular dermis matrix

• Result: Matrix supports cellular repopulation and vascularization at the surgical site. Supplied pre-hydrated & stored at room temperature

Precision Spinal Allografts• Application: cervical fusions, lumbar fusions &

spinal corrections• Study: Develop machining methods to create

intricate designs & consistent sizing• Result: Spinal fusion grafts including technique

specific precision shapes capable of restoring spinal function, enhancing patients’ lives & eliminates donor site pain associated with autologous grafting

• Application: ACL repair, eliminates pain associated with autologous grafting

• Study: Collaboration with Dr. Charlie Gatt, MD - determine donor criteria for BTB grafts– 100 Hemi BTB Grafts– Age Range: 16 – 69, sex matched

• Result: No statistical difference between age and sex

Bone –Tendon-Bone Allograft

AATB STAC Study on Fosamax

• Application: MTF currently rejects donors treated with Fosamax– Affect on bone transplantation unknown– # of donors treated with Fosamax continues to

increase– Effects both male and female donors

• Study: 4 Major tissue banks providing research tissue (DBM) to test difference in quality

• Result: Potentially broaden donor criteria increasing use of the gift

Non-standard Donors• Application: MTF donor age limit for weight

bearing tissues is 70• Study: Evaluate differences in cortical bone

from male donors 55-70 and 71-80 y/o• Result: Donors over 70 years of age are

not acceptable for weight bearing applications

Average UTS of Flexural Samples

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Research Tissue Program• Prosthesis attachment for war

veterans– 100 femurs– Development of fixation

• Development of a Device to Increase Proximal Femur Strength in Patients with Osteoporosis– Hip fractures– Method reinforcement with PMMA

cement to prevent repeat injury– Mechanical testing

Research Tissue Contd.• Geometric and material properties of

ACL, Patella Tendons and Hamstring Tendons– ACL graft failure risk factors– Male vs. female tissue– Dimensions and mechanical testing

MTF Directed Research

• Effects of Aging on Bone

• Evaluation of Bone Density Through Radiographic Techniques

• Effects of Processing and Low Dose Radiation on Cortical Bone Grafts

MTF Grant Recipients• Optimization of Novel Sterilization Methods for

Soft Tissue AllograftsPI: Michael Dunn, Ph.D. - UMDNJ-Robert Wood Johnson Medical SchoolAmount Funded: $125,000

• Osteoprogenitor Cell Differentiation When Cultured on Allograft BonePI: Stuart Goodman, M.D., Ph.D. - Stanford UniversityAmount Funded: $82,336

• Physiologic Loading for Long-Term Maintenance of Osteochondral Grafts in CulturePI: Clark Hung, Ph.D. - Columbia UniversityAmount Funded: $125,000

Summary

• Research tissue plays an important role in our ability to :– Honor & maximize the gift – Provide highest quality and innovative

allografts– Support progression of external research

• Without research consent, non-transplantable donors can not be used

Thank You!

Questions?