Testing and Trials

The technology behind Q-Cells® has been under development for decades at leading research institutions.  In 2004, Q Therapeutics began moving Q-Cells® from the laboratory to the clinic by defining a clear vision for the product, determining a manufacturing process to meet FDA guidelines and planning for clinical trials at top universities.

Q is working with the University of Utah's Cell Therapy Facility (CTF) for manufacture of Q-Cells to meet FDA guidelines for conducting clinical trials.  CTF, under the direction of Dr. Linda Kelley, has validated the manufacture of Q-Cells in their facility.  This is a major step in moving Q-Cells into clinical trials. 

 

Q plans to evaluate Q-Cells in initial clinical trials involving demylinating diseases (MS and TM) and in diseases requiring neuroprotection, initially in ALS (Lou Gehrig's Disease).  The first clinical trial will focus on demonstrating Q-Cells® safety.  In trials in MS and TM, we will also evaluate the ability of Q-Cells® to remyelinate neurons that have lost their insulating myelin layer.  Based on our work in models of demyelination, we believe that implanted Q-Cells® will perform their natural support role for neurons in the vicinity of the implant.  In trials in ALS patients, in addition to safety we will evaluate efficacy in slowing or stopping disease progression in light of promising results in animal models.

The localized nature of Q-Cells®, combined with a defined clinical path, should result in a rapid development timeline.  Success in the initial trials will also provide a proof of concept for treating other neurodegenerative diseases.  Future disease targets under evaluation include treatment of certain spinal cord injuries caused by physical trauma in which demyelination and neuron damage both contribute to dysfunction.