experiences with experimental treatments in humans with SCI. The Miami Project decided to initiate open communication with Dr. Huang to more completely understand his transplant procedure using olfactory bulb-derived fetal cells as a means to promote recovery of function following SCI. Miami Project scientists and other researchers have been experimenting with OECs as a potential cell therapy in experimental modes of SCI, however, limited data were available concerning the clinical use of these cells.
A first step in this information-gathering effort was to invite Dr. Huang to the Miami Project to present a lecture summarizing his clinical experiences. Dr. Huang presented a lecture entitled Transplantation of Olfactory Ensheathing Glia in Patients with Spinal Cord Injury, where scientists and clinicians had the opportunity to listen to his presentation and ask specific questions regarding procedures and outcome measures. Although this presentation provided new information, including the suggestion that some patients experienced Functional benefit, many important scientific questions were left unanswered and led to various concerns. One concern was the lack of appropriate outcome measures that would adequately access any long term benefits. Another was the lack of follow-up information that would help determine the incidence of adverse effects of the procedure.
Large numbers of individuals have undergone these procedures in Beijing. In an effort to obtain better scientific data, The Miami Project faculty decided it would be important to obtain first-hand information concerning the procedures and the clinical effects. To this end, two scientists/clinicians within The Miami Project traveled to Beijing and, over a ten-day period, had the opportunity to observe twelve patients, evaluating six of them for neurological function before and after surgery. It is important to note that several patients demonstrated a modest degree of improvement in Motor and sensory function. Interestingly, this improvement in neurological status occurred immediately after the surgical procedure. In addition to these positive findings, some adverse effects were also observed. For example, wound breakdowns were noted in two patients, one of whom had a reduction in leg function after surgery. Meningitis occurred in another, however, the Chinese doctors did not record these complications in the patients' medical records.
The Miami Project's representatives had the opportunity to observe what they describe as a relatively simple surgical procedure of cell injections into the spinal cord of four different patients. While they did have the opportunity to witness the surgical
procedures and examine some patients, they were not permitted access to the laboratory where the cells for transplantation were prepared. Therefore, little information is currently available concerning the cellular content of these human fetal olfactory bulb cultures. One cell preparation, however, that was not transplanted into a patient was provided to The Miami Project for analysis. This analysis has been initiated and is ongoing. At this time, apart from descriptions from Dr. Huang, researchers can only guess at the important aspects of the preparation such as: What method of cell processing was used? Does the transplant tissue actually contain OECs? In what stage of development are the cells? Even after having the opportunity to directly observe patients and the procedure, there are still many important questions that need to be answered that are critical for scientific understanding. A major limitation of Dr. Huang's work is lack of long-term assessment of neurological function. It appears that patients who undergo the surgery do not have a set schedule to return for follow-up assessments. Apparently, the only data collected is obtained immediately following the surgery, therefore, it is unclear if the benefits experienced in the short-term are maintained over time. Without consistent follow-up data in all patients, few conclusions regarding the long-term benefits and safety of this surgical procedure can be made. Additionally, when considering invasive surgical procedures in people with SCI, it is of utmost importance to understand the potential complications and risks of the procedure. The detection of adverse effects requires careful and consistent documentation. Presently, it does not appear that data related to adverse effects are being systematically collected and documented by the Chinese group. Therefore, if adverse effects such as Neuropathic Pain or tumor formation are occurring in this group of patients, these effects may not be detected and reported. While questions remain about the benefits and potential risks of this procedure, the observation that some functional improvements occur soon after the surgery is intriguing. The reason for these early improvements is unknown. One explanation for rapid nuerological improvements in some patients may be a trophic or nourishing effect. The transplanted tissue may be secreting growth factors that enhance nerve signal conduction in the synapses or along the axons. To better understand if a trophic effect is responsible for the functional improvements, researchers will need to conduct studies on the cells used for transplantation to determine if they actually release neuropathic (nerve nourishing) factors. If this can be confirmed, it would provide a clear rationale for their use. Because accurate and conclusive information concerning the surgical protocol, methods of cell processing, and the long-term safety of this procedure is lacking, The Miami Project's
