Latest update on Wise Young's umbilical cord blood stem cell clinical trials

Dr. Wise Young

At last Thursday’s Rutgers University Keck Center Open House, Dr. Wise Young, researcher who has dedicated his professional life to finding a cure for those with a spinal cord injury, provided the latest update on the U.S.-based clinical trials that he is looking to launch. Assuming all goes well, Wise believes that the trials can begin by January of 2022. To learn of eligibility requirements for this study, read the article HERE. If you wish to be notified of when they begin accepting applications, please send e-mail to Jim Bennett at jimbenn@rutgers.edu who will add you to his list to be alerted when recruitment begins later in 2021.

These trials were suspended due to the COVID-19 restrictions last year followed by the pullout of the company that was to provide the stem cells. Wise was then required to re-submit the application to the FDA which required a reset of the steps he had to take as well as recruit new providers of the stem cells and find investors to fund the study. Wise is seeking to recruit 40 candidates for this trial.

Based on what Wise shared on Thursday, here’s a timeline of what and when he hopes to accomplish over the next six months:

• August 2021 - submit an Investigational New Drug (IND) proposal which he hopes will be responded to within 30 days. This will be followed by a pre-IND meeting the following month.

• October 2021 - prepare and submit the IND for review and approval (expecting approval within 60-90 days)

• December 2021 - screen subjects for the trial at the Kessler Institute for Rehabilitation in New Jersey

• January 2022 - start clinical trials (3 subjects per week transplanted)

Finally, the cost of conducting these trials has also ballooned from the original $5 million estimate to now $8 million, so given that the original sponsor of the study withdrew, he now has to raise that money though he did not express much concern over it.