Past results of Umbilical Cord Blood Stem Cell clinical trials provide lots of hope for upcoming U.S. trials

Some 50 participants attended Wise Young’s April 15th presentation in San Jose.

“Can I get your name?”  The young man whispered his name.  “And what city are your from?”  He responded “----dale.”  I didn’t quite hear him and asked him to say it again.  “Palmdale.”  For a second, I thought to myself, wow, I know where that is.  It’s north of Los Angeles, about 350 miles or so from San Jose, but why did this man drive 350 miles to come to Dr. Wise Young’s April 15th presentation?  The next person who checked in was from Las Vegas.  Wow, that’s over 500 miles this person has driven to be at this presentation.  And so, people from far distances in Fresno, Los Angeles, Sacramento and other cities had driven up to the Bascom Community Center in San Jose for Dr. Young’s only public appearance in California to discuss the upcoming clinical trials of umbilical cord blood stem cells for complete chronic injuries between C5 and T11.

NorCal SCI’s co-founder, Franklin Elieh, has been following Wise’s (he likes to be called Wise) work for over two decades but had never met him in person.  And so, when we had a chance to host him to speak to the SCI community, we jumped on it.  His upcoming clinical trials are the only ones targeting the chronic population.  Most other trials focus on the newly-injured and so, it is deserving of a lot of attention and interest.

Dr. Wise Young with NorCal SCI co-founders Nick (in the back) and Franklin (in the front)

I met with him privately to discuss his work.  For 15 years, he’s worked to set up a China Spinal Cord Injury network of 25 centers in China where there are more chronic spinal cord injuries there than anywhere else in the world with over a million such cases. He gained a great deal of insight and experience from the larger population of SCI.

While in the early 2000s, there was a lot of talk involving the use of embryonic stem cells. “At the same time, we were reading a lot of studies involving the use of umbilical cord blood stem cells in rats, cats and dogs with great results and so, we decided to go that route and refine the method to ultimately be able to test them on humans,” explained Wise.  After four years of work to purify the process, they began the early safety phase of the study.  The interesting part of their work involves injecting the stem cells into the surrounding area of injury, somewhat unconventional as most other trials insist on injecting stem cells directly into the area of injury. 

Umbilical cord blood is a baby’s blood in the placenta, the richest source of stem cells available.  When combined with carefully-balanced doses of oral lithium, they have found the axons get more excited, grow more and stay in the spinal cord longer.  In the 42 subjects involved in their China studies, there’s been no loss of function in any patient which was reassuring.  But probably the most critical part of their studies involved the intense therapy each subject was put through.  “We called it the 6-6-6 program … six hours a day, six days a week for six months,” described Wise.  Following the injection of millions of stem cells, the subjects began their training which involved standing initially with assistance, then without any assistance, walking in a rolling walker with minimal or no assistance, and then walking with a 4-point walker with minimal or no assistance.  They walked three hours in the morning, three hours in the afternoon.

While walking was the primary focus of the study, some other interesting benefits were observed, too. Some subjects regained bowel and bladder function and eliminated use of catheters or other devices/drugs for bowel management.  Additionally, ground-to-wheelchair transfers were also observed as well as being able to roll in bed independently.  Blood clots and pressure sores were also significantly reduced.  Many males reported improvement in sexual functions, both with erection and ejaculation.

“I realized, due to our work in China, how wrong most scientists are about spinal cord injury,” quipped Wise.  For example, it’s presumed those with heavily atrophied legs would not be able to walk.  “We found that to be otherwise,” said Wise.  Much is made of scar tissue acting as a barrier for regeneration of axons.  “We found that to be completely erroneous,” continued Wise.  “We also found use of braces or mechanical devices interfered or prevented walking, including harnesses that hold the person while attempting to walk.”

You can read his published paper from the China/Hong Kong clinical trials HERE.

Throughout his presentations, he suggested that many myths involving recovery from SCI can be proven untrue.  For example, following a complete diagnosis of SCI, hardly any attempt is made to get the person to walk because it is assumed it’s not an attainable goal and that the focus should be more on activities of daily living.  Wise disagreed with that approach. 

Wise is convinced that the combination of stem cells, lithium and 6-6-6 is key to best results and they will be testing 27 subjects for their upcoming clinical trials which would be divided into three groups with different combination of protocols to see which combination would work best.

After his presentation, many of the attendees hung around to ask him specific questions and he patiently spent time with every one of them.

TO APPLY FOR ENROLLMENT IN THIS CLINICAL TRIAL: The FDA has granted approval for this clinical trial which will begin with 27 subjects. In order to qualify for this trial, you must have a complete injury between C5 and T11, be injured more than 1 year, 18-64 years old. Neurosurgeons are reluctant to inject above C5 because of the phrenic nucleus which if damaged, it could result in diaphragm paralysis preventing the individual from being able to regulate breathing on his or her own. Dr Young plans to have a separate trial for high quads after this one. There is no cost to participate in this clinical trial, but if selected, you would have to cover the cost of lodging and transportation in NJ for 6 months. If you wish to be considered, send an e-mail to Jim Bennett at jimbenn@rutgers.edu