Pictured at left: Myoblasts (muscle) cells under high power magnification growing in culture.
On March 9th and 29th, we published two articles about a ground breaking swallowing treatment initiative to infuse adult stem cells into a human tongue by Christmas day 2014. The high level project hypothesis is that by increasing muscle mass in a human tongue by way of an adult human stem cell infusion, this will create a stronger tongue resulting in an improved swallowing function. This article summarizes the work to date taking place at the Institute for Regenerative Cures (IRC) at the University of California Davis Campus.
The team at the IRC has focused on hiring a project manager, defining the culture and environment that will be used to grow the myoblasts (muscle) cells, developing an Internal Review Board (IRB) human trial protocol document, and developing the pre-Investigational New Drug (IND) information required by the Food and Drug Administration (FDA).
The project manager identified the culture medium to be used in a standard operating procedure (SOP) within UC Davis’s Good Manufacturing Practices (GMP) lab. This culture uses well-defined components and should be highly reproducible when the culture and technique is moved to the lab. The cells will be grown in a hypoxic environment (i.e. an environment with low oxygen levels). Several sources for obtaining myoblasts, which will be used in pre-patient work, are being explored. Options range from purchasing myoblasts from a commercial source or extracting them from mice.
An Internal Review Board (IRB) protocol and approval, required in all clinical trials involving human subjects (to protect trial subjects against undue health risk), is under development and will allow the team to collect muscle biopsies from patients to be used in the GMP facility as needed in this clinical trial.
The team is preparing for a pre-Investigational New Drug (IND) meeting with the FDA. This requires research targeted at confirming a new drug’s safety. Work currently being performed in the lab along with a recently completed study by researchers at the University of South Florida and UC Davis’s on adult stem cell tongue infusion will be used to develop the pre-IND meeting and discussion materials. This work is an important project building block that will promote keeping costs for this initiative low and the project on target for a December 2014 human tongue stem cell infusion.
Lastly, funding for this initiative which allows for a limited number (two to five) of trial participants has been raised through the generosity of private donors. Increased funding, which would allow for the addition of up to twenty total trial participants, is being actively explored.
The NFOSD Team will publish updates as new milestones are achieved.