Gliomatrix™ for patients
About AGI’s experimental treatment program
Research on animal model of spinal injury prove that the administration of a co-culture of olfactory glial cells with fibroblasts from the olfactory bulb in the collagen matrix to the site of the injury restores the continuity of the long tracts of the spinal cord and restores their functionality [J Neurotrauma. 2018 Jun 15;35(12):1367-1378]. Our own research using co-cultures of olfactory glia with fibroblasts from the olfactory bulb resulted in a significant return of neurological functions in a human patient with a complete disruption of the spinal cord [Cell Transplant. 2014;23(12):1631-55]. [link to Darek Fidyka subwebsite]
The surgical approach consists of two surgeries:
The first is aimed to obtain patient’s own olfactory bulb for preparation of the cell drug (called GliomatrixⓇ) and to prepare the patient’s sural nerve for its future harvesting.
The second surgery consists of a complex approach focused on removal of the posttraumatic spinal cord astroglial scar, implantation into the spinal cord stumps of 3-dimensional slices of GliomatrixⓇ and reconnection of the spinal cord ends with autologous sural nerve grafts.
The postoperative neurorehabilitation program consists of intense locomotor and sensory training and regular courses of repetitive transcranial motor cortex magnetic stimulation (rTMS). The patients are examined before and at regular intervals after surgery by renown world class experts in neurology and neurophysiology to increase the objectiveness of obtained results. The preparation of the Gliomatrix will be conducted in a laboratory facility certified for the production of ATMP cell products. The study will have the approval of the Bioethics Committee.
Is Gliomatrix for me?
Our new therapeutic protocol is dedicated to patients sustaining a complete spinal cord injury (ASIA A), who did not recover any neurological function (both sensory and motor) throughout a period of at least 6 months after injury. Our therapy is based on the unique properties of OECs to interact with host spinal cord astrocytes that, leads to opening of the astrocytic barrier and allowing for central axon elongation. Olfactory ensheathing cells (OECs) and olfactory nerve fibroblasts (ONFs) are able to attract and guide the regrowing axons to their target neuronal populations. This unique neurotrophic activity of OECs, the miracle cells from the central nervous system, has been described in hundreds of scientific papers in the last 4 decades.
In result, a complex nonselective recovery of neurological function is expected, starting from recovery of deep sensation, sensation of touch, pain and temperature, and next recovery of voluntary muscle contractions. Finally, a recovery of bladder and bowel activity as well as sexual activity may also occur.
The therapeutic approach uses non-modified glial cells obtained from the patient’s own central nervous system (the olfactory bulb) and prepared in a way to make them survive in the spinal cord for a period long enough to guide the damaged spinal cord axons to their targets. The application of autologous nerve grafts for bridging the spinal cord gap gives the ideal neural tube for attraction and protection of regrowing spinal cord fibers. Such nerve grafts have been used successfully for 40 years in the peripheral nerve reconstruction surgery.
In conclusion, we offer to our patients a strong natural regeneration-promoting strategy, that is based on the application of the most unique triggers of central regeneration – bulbar OECs, in combination with peripheral grafts guiding tubes. Our therapy does not interfere with the novel neuromodulation methods, used in patients with spinal cord injury. Every neurological recovery observed in our patients can be increased by an intense program of neurorehabilitation, and leaves also a possibility of implantation of a spinal cord stimulator to strengthen the desired effect, depending on the individual case.