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Establishment of Cell Culture Systems From Discarded Operating Room Tissue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Wake Forest School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01000077
First received: October 21, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition
Surgery

Study Type: Observational

Further study details as provided by Wake Forest School of Medicine:

Estimated Enrollment: 1000
Study Start Date: February 2009
Groups/Cohorts
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.
Discarded Placenta
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.

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

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000077

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Rachel Shertzer-Skinner    336-716-4131      
Principal Investigator: Steve Hodges, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steve Hodges, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01000077     History of Changes
Other Study ID Numbers: IRB00007586
Study First Received: October 21, 2009
Last Updated: October 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Regenerative Medicine
Tissue Collection
Cell Culture Systems
Routine Surgery

ClinicalTrials.gov processed this record on November 25, 2014