We proved that the natural activity of the immune system can protect nerve cells against degeneration and also help in recovery following CNS (Central nerves system) trauma
Technology
Proneuron Biotechnologies is enrolling patients suffering from complete spinal cord injuries to participate in a Phase II multi-center clinical study. Patients within 14 days of injury will be implanted with ProCord. Proneuron Biotechnologies, a Delaware company, is in advanced stages of clinical development in a number of attractive neurological markets. Proneuron is the first company to harness the power of the body's own immune system for the treatment of debilitating central nervous system (CNS) disorders. The concept of helping the body to "cure" itself, offers hope to the millions of victims of nervous system-related disorders. Proneuron Biotechnologies is developing therapies for neurological disorders, including spinal cord injury (SCI), other central nervous system trauma and back injuries. Our products are based on proprietary technology for modulating the interaction between the nervous system and the immune system. Proneuron is enrolling a total of 61 patients suffering from complete spinal cord injuries in a Phase II multi-center clinical study. Patients will be implanted with ProCord. Study sites must be informed of a candidate patient within a few days of the spinal cord injury to allow time to complete the necessary tests and procedures within 14 days of injury.
We proved that the natural activity of the immune system can protect nerve cells against degeneration and also help in recovery following CNS (Central nerves system) trauma
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Antibody
A component of the immune system evoked by the stimulus of a foreign substance (antigen) which reacts specifically with the antigen.

Antigen
A foreign substance which is identified by the body's immune system and is attacked through humoral and cell-mediated immune response.

Autoimmune Diseases
Conditions in which the body's immune system mistakenly attacks a patient's own organs and tissues.

Autologous
Originating from self. Tissue grafted from one part of the body to elsewhere on the same patient is considered autologous.

Axon
Long fiber-like extension of a nerve cell that carries impulses.

B-cell
A class of lymphocyte responsible for producing soluble antibodies called immunoglobulins.

BLA
Biologic License Application. Application to the FDA for permission to market a biological product. The FDA definition of a biological product includes any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injury.

Cell therapy
Treatment that makes use of living cells from a culture or a donor.

CNS
Central nervous system, comprising the brain, spinal cord and optic nerves.

Control sample(s) in an experiment
"Null" treatment used for comparison. e.g. animals treated with a drug are compared to control animals that do not receive the drug.

Dendrite
Fine cytoplasmic process on a neuron that receives signals from other neurons.

Enzyme
Proteinaceous molecule that acts as a catalyst, controlling the rate of a specific chemical reaction. A large array of different enzymes provides the metabolic web that allows the processing and interconversion of diverse molecules within the body.

Ex Vivo
Outside of the living body.

FDA
Food and Drug Administration of the United States of America.

Gene
A unit of inheritance. At the molecular level, genes are sequences of nucleotides (DNA) that usually code for proteins.

GMP
Good Manufacturing Practice. Standardized procedures required by regulatory authorities to ensure consistent and safe production of a therapeutic product.

Immunity
Resistance to invading pathogens provided by the specific and non-specific cells of the immune system.

IND
Investigational New Drug: Regulatory submission to the FDA in order to receive permission to proceed with clinical trials in humans. An IND document contains data on preclinical studies (laboratory and animal experiments), toxicology, pharmacology, manufacturing, and quality control.

In vitro
Outside the living body and in an artificial environment (such as a laboratory).

In vivo
Inside the living body.

IRB
Institutional Review Board (sometimes called Helsinki or Ethics Committee). Commitee designated to review and authorize any biomedical research involving human subjects.

Lymphocyte
A type of white blood cell responsible for the antigen-specific reactions of the immune system. The major classes of lymphocytes are B-cells and T-cells.

Macrophage
A type of white blood cell and component of the immune system which engulfs invading organisms and co-operates with other white blood cells in immune and inflammatory reactions.

Microglia
Macrophage resident in the CNS.

Monocyte
Precursor cell that circulates in the blood and develops into a macrophage.

Neuron(e)
Basic electrical signal-conducting cell of the nervous system, consiting of cell-body, dendrites and axons.

NDA
New Drug Application. Application to the FDA for permission to market a new drug.

Peptide
A chain of several amino-acid residues linked by peptide bonds. Longer chains containing tens or hundreds of amino-acid residues are usually called polypeptides.

Phase I Clinical Trials
First stage of drug testing in humans. Phase I are designed for safety testing and typically involve few (up to 20) subjects (normal volunteers or patients). The exact number of subjects for each phase of clinical trials (Phase I, II, or III) is determined based on the product tested, patient population, disease prevalence, and the hypothesized efficacy rate of the drug.

Placebo
An inert or innocuous substance used specially in controlled experiments testing the efficacy of another substance (as a drug).

PNS
Peripheral nervous system. The nervous system that serves the limbs trunk and internal organs, i.e., all nerves except the nerves of the brain, spinal cord and visual system.

Protein
Large molecule composed one or more polypeptide chains, and often additional chemical factors. Proteins serve as structural building blocks, as enzymes that catalyse the biochemical reactions of the body, and as transmitters and receptors of most of the chemical signals within and between cells.

Receptor
A molecule on or within a cell membrane or inside the cell, to which a substance such as an agonist or a ligand selectively binds to trigger a biological response.

T-cell
A class of lymphocyte that mounts a cell-mediated immune response against an antigen. The body has different classes of T-cells, such as cytotoxic (killer), memory, helper, and suppresser T-cells.

Vaccination The administration of antigens into the body, with the aim of priming a lasting, specific immune response.



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Proneuron Biotechnologies is engaged in research
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