Duke Set to Launch Phase I Clinical Trials for Brain Cancer Patients

ALD-451 is the population of autologous pluri-potent ALDHbr adult stem cells isolated from the patient's bone marrow using proprietary technology by Cytomedix Inc., a Gaithersburg, Md.-based regenerative therapies company. The ALD-451 cells express high levels of the enzyme ALDH, an indicator of biological activity in heterogenous early stage stem cells.

Preliminary data presented at the 2012 International Society of Cell Therapy showed that ALDHbr cells reduced severity of intracranial inflammation after brain irradiation in an animal model. Investigators also have completed preclinical research showing improvements in motor function, a slowdown in the decrease in brain volume, reversal of decline in stroke-induced cell viability and improved blood flow in the brain, according to Cytomedix.

The Duke study will enroll up to 12 patients and is intended to demonstrate the feasibility and safety of ALD-451 when administered intravenously in malignant glioma patients following surgery, radiation and chemotherapy. Around 80 percent of malignant brain tumors are gliomas, according to the American Cancer Society. Malignant gliomas frequently invade normal brain tissue, making treatment difficult.

The study, which is also exploring how ALD-451 affects neurocognition, is being led by Dr. Annick Desjardins of Duke's Preston Robert Tisch Brain Tumor Center. Co-investigators are Dr. Henry S. Friedman, the center's deputy director, and Dr. Joanne Kurtzberg, chief scientific officer and medical director of Duke's Robertson Clinical & Translational Cell Therapy Program.

The Robertson Clinical & Translational Cell Therapy Program will fund the trial and be responsible for all other aspects of the study, while Cytomedix will be manufacture ALD-451 for the clinical trial.

Learn more:
Cytomedix (pdf)