It is Neuroplast BVs commitment to ensure that their lead therapeutic interventions are commercialized as soon as possible, to increase quality of life of the patients suffering debilitating neurodegenerative disorders including idiopathic, post-traumatic and ischemic neurodegenerative disorders without restorative therapeutic perspectives. Especially of interest are diseases such as traumatic spinal cord injury, parkinsonism, multiple sclerosis, amyotrophic lateral sclerosis and Ischemic stroke. Important within Neuroplast is to translate science into therapeutic strategies, which can be achieved realistically in time and gain life time for patients with a fatal and/or stark debilitating disease. Important within Neuroplast is to translate science into therapeutic strategies, which can be achieved realistically in time and gain life time for patients with a fatal and/or stark debilitating disease. Important are the commitment of science and the authorization of the EMA for their products.
Neuroplast BV is active in the arena of ATMP’s and combines this with experiences gathered in the medical devices industry.
Therefore, Neuroplast develops a most promising strategy: the re-application of human autologous crude bone marrow-derived stem cell preparations transformed into AMARYLLIS-manufactured and EMA-authorized, dedicated low-immunogenic, not-manipulated Neuro-Cells, free of pathogenic micro-organisms. Re-applied within the central nervous system (spinal fluid), these stem cell preparations are hypothesized to slow down and/or to reduce neurodegenerative processes, thus interfering with the pathophysiological processes of these various neurodegenerative disorders and bringing down the expression as well as the progression of them.
As both the quality and the quantity of autologous stem cells decreases during aging, when the risk to develop idiopathic neurodegenerative diseases increases, Neuroplast concentrated on developing low immunogenic stem cell preparations, allowing to treat these patients also with allogenic stem cells, without the risk to initiate graft versus host reactions.
Additional to the realization of these concrete therapies, Neuroplast also concentrates on developing a hybrid point-of-care concept, meeting both actual point-of-care and GMP regulations, by licensing the AMARYLLIS platform with dedicated disposable kits to manufacture bone marrow-derived stem cell preparations without any risk of contamination.
This CE certified medical device enables the treatment with autologous inflammatory inhibiting stem cells in every hospital including army field hospitals all over the World.
Neuroplast BV is interested to develop autologous and/or allogenic safe stem cell preparations for the treatment of neurodegenerative disorders, including ischemic cerebrovascular disorders, dementia, parkinsonism, multiple sclerosis and amyotrophic lateral sclerosis as well as posttraumatic cerebral and spinal cord disorders. All these disorders share neurodegeneration and the lack of any restorative therapy. The table attached provides an overview of the incidence and prevalence of the diseases of interest for Neuroplast.
The first indication Neuroplast BV wants to achieve is spinal cord injury (SCI). This is a mainly young-onset, life-long, debilitating disorder due to traumatic lesion of the spinal cord with interruption of the ascending and descending neural tracts, clinically manifesting with flaccid paralysis of arms and/or legs, and incontinence, pending the (cervical/lumbosacral) level of the injury. SCI comes with a shortened life-expectancy and has serious consequences for the quality of life.
The development as well as the regeneration of tissues and organs throughout life is pending the presence of stem cells. In nearly every area of the body, small amounts of silent, partly differentiated stem cells wait to replace damaged cells, especially in the bone marrow, where these cells continuously replace old and damaged white and red blood cells. Stem cells also play a role in the defense of the body against various insults. For instance in case of hypoxia-induced insults, stem cells can prevent cell death by stimulating neo-angiogenesis (the development of micro vessels in the ischemic area), and in case of inflammation, pending its magnitude, stem cells can activate or deactivate the inflammatory processes.
In the central nervous system, there is a lack of stem cells, and in case of any insult stem cells therefore have to be attracted from the bone marrow. Although these cells are able to migrate to inflicted areas, unfortunately, they can only pass defect and not intact blood-brain-barriers. Therefore, in the treatment of neurodegenerative disorders, stem cells have to be applied in the same compartment (for instance by intrathecal application into the cerebrospinal fluid). Stem cells can be harvested from embryonic tissue (embryonic stem cells), from umbilical cord blood (cord blood-derived stem cells), from bone marrow or other stem cells-containing organs (adult stem cells) or reprogrammed from normal tissue cells (induced pluripotent stem cells). Only adult stem cells and induced pluripotent stem cells can be harvested and re-administered in the same (autologous stem cells) or another (allogenic stem cells) person.
As of yet, neurodegenerative disorders only have symptomatic treatments, balancing between effectivity and side effects, and lack strategies to slow down or even stop their progression. So, pending the progression of these disorders, life-expectancy will be reduced, and patients will lose their independency as well as their quality of life.
During the last decade, studies in experimental animal models of neuro-degenerative disorders suggested significant benefits of stem cells, although the way of action could not be fully established. Scarcely published open human trials with autologous stem cells also suggested beneficial effects, but an academic, translational step towards a concrete therapy in humans is not yet made. Neuroplast BV is one of the few world-wide companies translating science into feasible and safe products with the potency to inhibit the progression of these disorders and gain time as well as quality of life for patients suffering these debilitating degenerative disorders (see our publications).
Stem cell transplantation therapy to replace blood cells in certain cases of leukemia is common practice in medicine for over 30 years. The use of intrathecal re-applied stem cells to regenerate and/or rescue damaged neural tissue, supposedly by inhibiting inflammatory processes and secreting paracrine factors, however, is new. In the next future, Neuroplast BV will market their stem cell preparation (Neuro-Cells) to acute or chronic spinal cord injury patients.
Neuroplast BV uses autologous bone marrow-derived stem cells, safely harvested by collecting bone marrow aspirate containing stem cells out of the hipbone of the patient. ASC processes this aspirate via their special platform (AMARYLLIS) in a patented way, and concentrates the solution into a small volume (Neuro-Cells) for intrathecal administration. Neuro-Cells is supposedly capable of slowing down or blocking inflammation, and secreting paracrine (neurotrophic) factors which will increase neuroplasticity, and by doing so, saving jeopardized neurons from dying