Phase II Pathway Study Clinical Trial for Cervical Spinal Cord Injury
Pathway Study Sponsored by StemCells, Inc.
October 2014 – Drs. Allan Levi, Kim Anderson, and Diana Cardenas of The Miami Project and several other University of Miami faculty members are the first site to begin participating in the new phase II Pathway Study sponsored by StemCells, Inc.
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.
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).
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 Phase I clinical trial 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 trial designed to determine if neural stem cells can help people recover spinal cord function and gain strength and sensation.
Individuals may be able to join the study if they are 18 to 60 years old, have a cervical spinal cord injury that is classified as AIS grade A, B, or C, are less than two years post-injury, and are generally in good health. Individuals that are eligible for the study will participate for approximately 12 months, and will visit The Miami Project clinical research center approximately 6 to 10 times during that time frame.
To find out more about eligibility, visit http://www.sciresearchstudy.com or call the Miami Project Education office at 305-243-7108.