Institutional Review Board, Hospital for Special Surgery
March 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.
Wei Zhu, PhD
Bernard A. Rawlins, MD: (212.606.1632)
Oheneba Boachie-Adjei, MD: (212.606.1948)
Carl P. Blobel, MD, PhD: (212.606.1429)
Lionel B. Ivashkiv, MD: (212.606.1653)
Aaron Daluiski, MD: (212.606.1284)
Hao Zhang, MD: (212.774.2529)
Anju Roy, PhD: (212.774.7087)
Naobumi Hosogane: (212.606.1948)
No more than 80 patients at ages ranging from 18 to 80 year-old including both male and female will be recruited in this study. Approximately 10ml (two tea spoons) bone marrow samples will be aspirated from the iliac crest (hip bones) of each patient during bone grafting procedure of spine surgery. Bone marrow cultures will be established in laboratory and studies will be performed to examine the Osteogenic potential of these marrow stem cells to turn into bone-producing cells (osteoblasts).
This study will increase our knowledge on the mechanisms of turning stem cells into bone-producing cells, and may lead to the development of stem cell-based therapies for the enhancement of bone formation or regeneration.
Inclusion criteria:
Patients of Drs. Rawlins and Boachie, ranging in age from 18 to 80 (both female and male) who will be undergoing spine surgery involving a bone grafting procedure.
Exclusion Criteria:
Patients that have metabolic bone disease, parathyroid or thyroid diseases; who have received bone morphogenic proteins (BMPs); who smoke or are taking medications that can affect bone integrity, such as steroids, epileptic drugs, etc.; or who have received treatments and drugs that may affect the normal functions of bone marrow cells will be excluded in this study.
Wei Zhu, PhD
212.774.7017
zhuw@hss.edu
Bernard A. Rawlins, MD
212.606.1632
rawlinsb@hss.edu
Oheneba Boachie-Adjei,MD
212.606.1948
boachie@hss.edu