Establishment of Cell Culture Systems From Discarded Operating Room Tissue

Surgery Clinical Trial

Official title:

Establishment of Cell Culture Systems From Discarded Operating Room Tissue

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01000077
• Other study ID #: IRB00007586
• Status: Enrolling by invitation
• Start date: February 2009
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	United States Department of Defense

Country where clinical trial is conducted

United States,