Stages of Disc Degeneration leading to disc herniation
Low back pain from degenerative disc disease
Study is looking at a potential new treatment (an investigational product) for people with degenerative disc disease. The investigational product is made from certain type of adult stem cell. Stem cells are immature cells produced by the human body that have the ability to develop into many different types of cells. The stem cells that are looked at in this study are called mesenchymal precursor cells. The cells being used in the study have been carefully collected from bone marrow samples from healthy human adult donors and grown in a laboratory under strict condition.
Participants will receive a single injection of investigational product. However, since this is a double blind study, neither participant nor the physician who follows up the patient will know exactly what was administered. There are 2 in 3 chances of receiving the investigational product. The injection will be assigned randomly.
Everyone who participates in the study will receive either stem cells (investigational product), an investigational product combined with Hyaluronic acid, or a saline solution, which look like an investigational product. There are 2 in 3 chances of receiving the investigational product and 1 in 3 chances of receiving saline.
No longer recruiting
Since majority of the low back pain cannot be attributed to single cause they are often called nonspecific back pain. The purpose of this research is to comparethe effects of the investigational drug, Tanezumab, with another drug called tramadol and a placebo to find out which is better for treating chronic low back pain. Tramadol is a drug that is approved by the USA FDA to treat moderate to severe pain in adult and children over 12 years. Tanezumab* is an investigational drug.
An investigation drug is one that is not approved for sale in this country by the US FDA. A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity. NGF levels increase as a result of injury or inflammation and in chronic pain states. Tanezumab selectively binds to NGF, thereby inhibiting this protein from activating pain-signaling neurons.