Establishment of Cell Culture Systems From Discarded Operating Room Tissue
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|ClinicalTrials.gov Identifier: NCT01000077|
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2009
Last Update Posted : August 31, 2020
|Condition or disease|
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.
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.
Approximately 1000 people will take part in this study, all of them at Wake Forest University Health Sciences or Forsyth Medical Center.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Establishment of Cell Culture Systems From Discarded Operating Room Tissue|
|Actual Study Start Date :||February 2009|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Discarded Operating Room Tissue
The purpose of this research study is to use the discarded (tissue that would normally be thrown out) tissue from your surgery in order to obtain cells that can be grown in a laboratory to study how to use cells like these to fix sick and diseased organs. We will test if these cells can be used to build new and healthy tissues. This technique is called tissue engineering. In this study we will be comparing cells obtained from different individuals.
During a standard surgery or delivery of a baby unneeded tissue is usually discarded. We would like to explore the opportunity to grow the cells of these discarded tissues in the laboratory. The cells will be placed in special dishes and supplemented with a mixture of salts and nutrients that were designed to allow the cells to survive outside the body and grow. This procedure is called tissue culture of cells. We will attempt to isolate a population of cells from the tissue culture and study them in the laboratory.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000077
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Steve J Hodges, MD||Wake Forest University Health Sciences|