Wise Young's Umbilical Cord Blood Stem Cell clinical trials experience temporary setback

Dr. Wise Young

At last Friday’s Open House presentation, noted researcher Dr. Wise Young, who had hoped to begin in 2020 the FDA-approved clinical trials involving the use of Umbilical Cord Blood Stem Cells, shared an update on the state of his work as he revealed that StemCyte, an umbilical cord stem cell blood bank in Baldwin Park, Calif., had withdrawn its sponsorship of the study, effectively bringing the entire trial plans to a halt. Furthermore, StemCyte had moved the trials to Taiwan, forcing Wise to scramble and pull together a new coalition of blood banks as well as developing a new application to the FDA for approval.

As a result, Wise made several changes to the study protocols as he’s working to submit to the FDA his request for approval of the trials, something he hopes to accomplish over the next few weeks. He also needs to raise several million dollars to help fund the trials. If everything goes well, he hopes to begin recruiting candidates by late summer/early fall. The parameters for study inclusion have not changed: C5 through T11 Complete ASIA A injuries greater than one year, persons 18-64 years old, and injury site is less than three vertebral levels on MRI scan.

NOTE: 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. And for those T12 or lower, lumbosacral injuries require neuronal replacement which Wise didn’t think was possible with umbilical cord blood injections. Recent animal studies have shown that is possible. He is very encouraged by this but it's too early to act on. Incompletes are not being allowed into this phase by the FDA out of concern that such individuals may be at a risk of losing function they may have due to their incompleteness.

The trials are likely to take six months between the surgical injection of the cells and multiple weeks of intense therapy at five rehab centers in New York, New Jersey and Pennsylvania as well as additional facilities for other variations of the physical therapy included in the study.

You can watch the recording of his presentation HERE where during the first 48 minutes, Wise covers the origins of the study. After the 48th minute of the recording, Wise begins to update where the study is right now, the steps he’s taking to resume it and answering a few questions. It was announced that at their Fri., March 5th Open House, Wise would devote the entire time to answering questions from the audience. We will keep you posted as soon as registration for that session opens up.