TOKYO -- A Keio University panel is set to approve an in-house clinical trial plan to transplant neural cells made from iPS cells into patients with spinal cord injuries in a bid to improve their motor and sensory functions -- marking a global first, according to the university.
The university's team of researchers led by professors Hideyuki Okano, a physiologist, and Masaya Nakamura, an orthopedic surgeon, wants to start the transplants as early as the summer of 2019, after their plan is approved by the government.
The trial, to be cleared by the university's certified special committee for regenerative medicine which met on Nov. 13, will be conducted on four patients aged at least 18 who completely lost their motor and sensory functions due to spinal cord injuries sustained two to four weeks earlier. As many as 2 million neural stem cells and neural progenitor cells grown from iPS cells will be transplanted in the damaged section of each patient's spinal cord.
The iPS cells, or induced pluripotent stem cells, are capable of turning into any type of cell, including neural stem cells and neural progenitor cells. The iPS cells used in the trial are those stored at Kyoto University's Center for iPS Cell Research and Application.
The patients will also receive medication to control immune reactions to the transplanted cells as well as physiotherapy. They will be monitored for one year following the operation to check if the transplanted cells would turn into tumors, and if they would develop into functioning, full-fledged nerve cells that can make the patients move or feel.
Professor Okano and others have carried out regenerative medicine research projects aimed at treating patients with spinal cord injuries since 1998 using embryonic stem cells. In a 2012 study, Okano and his team transplanted neural progenitor cells made from iPS cells into a monkey with paralyzed limbs due to spinal cord injuries. After six weeks, the animal was able to stand on its own hind legs and recovered hand grip. No tumors were observed three months after the transplant.
As many as 5,000 people suffer spinal cord injuries every year in Japan, according to the Japan Spinal Cord Foundation. No effective treatment to cure the damage is available now.
(Japanese original by Suzuko Araki, Science & Environmental News Department)