Establishment of Cell Culture Systems From Discarded Operating Room Tissue

Healthy and diseased tissue will be harvested from tissue routinely discarded in the NCBH
operating rooms, or from delivery rooms at Forsyth Medical Center during routine operative or
childbirth procedures. Samples will be identified by source and disease state only. Disease
state may be of several types including inflammation, malignancy, fibrosis, atherosclerosis,
hyperplasia etc. These tissue samples will be promptly transported under sterile conditions
to the Institute of Regenerative Medicine. The tissues will be broken down into individual
cells by mechanical or enzymatic methods, diluted with growth media and inoculated onto
sterile tissue culture flasks. The flasks will be placed into a 4% CO2 incubator for culture.
The cultures will be cultivated for primary and progenitor cells and eventual RNA extraction
and expression profiling. These cell lines may be then used for future in vitro and in vivo
research studies yet to be determined. An Institutional Review Board (IRB) must approve any
future research study using these tissue samples.

Source of Specimens:

Healthy and diseased tissue from a variety of sources (examples include bladder, foreskin,
heart valves, blood vessels, prostate, kidney, uterus, ovary, salivary gland tissue, lacrimal
gland tissue, muscle tissue, epithelial tissue, nerve tissue and vascular tissue from
patients undergoing surgery) will be harvested from tissue routinely discarded in the NCBH
operating rooms during routine operative procedures. In addition, normal term placentas will
be obtained following vaginal deliveries at Forsyth Medical Center. No patient identifying
information will be retained. No attempt will be made to match established cell lines derived
from the tissue samples with the source patient. Eligibility for the protocol is restricted
to an indication for surgical excision of the tissue in question.

Confidentiality Considerations:

No patient identifiers will be collected. It will not be possible to identify or link any
tissue to the individual patient source in any way once it has been delivered to the
Institute. The only information identifying the specimen will be tissue source, age and sex
of patient, and disease state (if any). Informed consent will be obtained.

Sample Size:

Approximately 1000 people will take part in this study, all of them at Wake Forest University
Health Sciences or Forsyth Medical Center.

Eligibility Criteria:

- The subjects would include anyone undergoing a surgical procedure by one the of the
surgeon co-investigators, during which discard tissue may be harvested.