Clinical Trials

Clinical Trials


images
 We visited the W.M. Keck Center for Collabrative Neuroscience at Rutgers University in September 2012.  The mission of the Keck Center is to develop treatments for acute and chronic spinal cord injuries and to move these dicoveries from laboratory to human lives as rapidly as possible.

Dr. Wise Young, the founding direcot of the center, is one of the world’s outstanding neuroscientists.  He was part of the team that discovered and established high-dose methylprednisolone (MP) as the first effective therapy for spinal cord injuries.  He also developed the first standardized rat spinal cord injury model used world wide for testing therapies

Dr, Young wrote “A Therapy Road Map” which gave us some idea of the clinical trials going on at present and those planned in the near future.  Many laboratories have reported the transplant of umbilical cord blood mononuclear cells  (UCBMC) have improved functional recovery in animal spinal cord injuries.  Many laboratories have reported the transplantation of umbilical cord blood mononuclear cells (UCBMC) have improved functional recovery in animal spinal cord injuries.  Cord blood stem cells are an attractive source for transplantation since it is rich in stem cells and contains more stem cells per volume than bone marrow.  Cord blood banks have stored over 200,000 donated cord blood units that are available for transplatation around the world.  In addition, a laboratory at Hong Kong University discivered that Lithium stimulates regeneration and improves recovery in rats with spinal cord injuries.  This finding has been confirmed by two other laboratories.

A series of clinical trials are underway in China to evaluate the use of these two therapies. The trial which used only Lithium therapy in patients with spinal cord injuries found pain was reduced.  In another trial, the injection of only UCBMC above and below the injury site resulted in improved locomotor function.

Based on these results, phase 3 trilas in China are underway which randomize treatment to include UCBMC only and UCBMC + Lithium.  The results are nearing completion and are expected to be published in medical journals this spring or summer.

Phase 3 trials are planned  in the United States, Norway, and India similar to those being conducted presently in China.  The USA trials are schedules for September 2013 in New Jersey.  There will be 20 patients chosen for the initial trial and the group will then be expanded by an additional 100 patients later.    Positive results in these phase 3 trials  and the China trials would be a first in history event.  No treatment has ever been reported to regenerate the human spinal cord and improve functional recovery in patients with chronic spinal cord injuries.

We met one on one with Dr. Young during our visit to Rutgers.  He said “Finding a cure is no longer a question of if, but when.”  This gives us hope that Steve will walk again.

Ralph & Barbara Pattelena

To learn more visit the Keck Center for Collaborative Neuroscience website.