THE PATHWAY STUDY HAS CLOSED ENROLLMENT AS OF MAY 31 2016!
Researchers are currently evaluating the potential of stem cell transplantation as a treatment for many neurological disorders, including spinal cord injury (SCI). Stem cells are unique from other cells in the body:
- Stem cells can self-renew (make copies of themselves)
- Stem cells can respond to signals within the body and become specialized (this is known as differentiation)
Studying stem cell transplantation for SCI may help us learn if stem cells can help either replace or repair spinal cord cells that were damaged by injury which may in turn improve spinal cord function.
The Pathway Study is testing the safety and potential benefit of a very specific stem cell type known as a neural stem cell. Neural stem cells are derived from brain tissue and have the ability to self-renew and become the main types of mature cells found both in the brain and spinal cord. Studies of spinal cord injury in animals have shown that the human neural stem cell can survive and lead to recovery of function. A recent study conducted in humans with thoracic spinal cord injury indicates that neural stem cell transplantation appears to be safe. The Pathway Study is a larger clinical research study designed to determine if neural stem cells can help patients recover spinal cord function and gain strength and sensation.
Clinical research studies (also called clinical trials) are done to test investigational treatments for diseases and disorders, as well as test new medical procedures or devices used in these conditions. Clinical trials determine if treatments, procedures, and devices are safe to use and can improve the health of people suffering from these conditions. Before a new medication or medical device can be made available to the general public, it has to go through several phases of clinical research. All prescription medications that are sold and used today have been tested in clinical trials.
The purpose of the Pathway Study is to evaluate the safety and potential benefit of an investigational product called human central nervous system stem cells (HuCNS-SC®) for people with cervical spinal cord injury (cSCI). What we learn in this study may help us understand more about spinal cord injuries and help us develop future treatments.
There are 13 trial locations in the United States. They are in Houston, TX; Miami, FL; Salt Lake City, UT; Minneapolis, MN; Milwaukee, WI; Chicago, IL; Ann Arbor, MI; Pittsburg, PA; Baltimore, MD; Philadelphia, PA; New York, NY; Palo Alto and Downey CA. There may be other sites opening up in the future.
Six-month interim data for the first cohort of the Pathway Study showed the first-ever clinical evidence of a treatment effect improving both muscle strength and motor function following cellular transplant in spinal cord injury. Top-line data from the Company’s Phase I/II clinical trial in thoracic SCI showed measurable gains involving multiple sensory modalities and segments, including the conversion of two of seven patients enrolled in the study with complete injuries to incomplete injuries, post-transplant.
SNNLive spoke with Ian Massey, President and CEO of StemCells, Inc. (NASDAQ: STEM) at the Source Capital 2016 Disruptive Growth & Healthcare Conference in New York City, NY.
You may be able to join the study if you are 18 to 60 years old and:
- You have a cervical spinal cord injury that is classified as AIS grade A, B, or C
- It has been less than two years since your injury occurred
- You are generally in good health aside from your spinal cord injury
There are other criteria that you must meet to participate. The study staff can discuss these criteria with you in greater detail.
THE PATHWAY STUDY HAS CLOSED ENROLLMENT AS OF MAY 31 2016!
