Clinical trial NCT01000077: Establishment of Cell Culture Systems From Discarded Operating Room Tissue
Official title: Establishment of Cell Culture Systems From Discarded Operating Room Tissue
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Surgery
Keywords: Regenerative Medicine
Tissue Collection
Cell Culture Systems
Routine Surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-10-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 28
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There is no specific study population for the this study. The patients from whom discarded tissue will be harvested will be any patients within the set age criteria in the operating room that have viable tissue excised for discard. In other words, when any investigators from the study have discard tissue as a result of a surgical procedure, this tissue will be a possible specimen for use in the protocol. Only discard tissue will be used, however, so if the tissue isn't used in the study, it would simply be thrown away.

Brief summary: The purpose of this study is to establish viable cell culture system techniques for a variety of healthy and diseased tissues for use in future in vitro and in vivo research studies in tissue engineering.

Detailed description: 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: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve J Hodges, MD
role: PRINCIPAL_INVESTIGATOR
References: