Research

A Pilot Study to Obtain Initial Information on Gene Expression in the Human Intervetebral Disc: The Origin and Fate of the Nucleus Pulposus

IRB Number: 26114
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

February 13, 2007

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Federico P. Girardi, MD

Co-Investigators

Frank Cammisa, MD
Andrew Sama, MD
Stephen Doty, PhD
Joseph Schwab, MD
John H. Healey, MD

Summary

The researchers at Hospital for Special Surgery are trying to learn more about spine diseases. The purpose of this research study is to determine the abnormal gene associated with spine diseases.
We will obtain samples of tissue that would normally be thrown out after your surgery.  Taking out this extra tissue will not make your surgery longer than it would normally be.  We will use these tissues to obtain the gene information and hopefully to identify the appropriate gene which contribute to the type of spinal disease that you have.
This study is planning to enroll 30 subjects. Your participation will involve only your visit on the day of surgery.

Inclusion/Exclusion Criteria

Inclusion Criteria:

  • Patient age is between 10 to 70 years of age.
  • Patient is surgical candidate with disc excision.

Exclusion Criteria:

  • HIV positive.
  • Any steroid usage in the last 4 months.
  • History of cancer.
  • Has active infection.
  • History of inflammatory disease.

Contact Information

Kai Zhang
Spine Service Research Coordinator
212.774.7066
zhangk@hss.edu



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