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Brain cell transplant

cell-growDifferent regions of the brain and spinal cord house different, specialized cells. Neuralstem’s technology enables the isolation and expansion of human neural stem cells from each of these regions of the developing cen­tral nervous system (CNS) in virtually unlimited numbers from a single donated tissue.

The goal of cell therapy is to replace and/or repair dead or diseased cells. Unlike other stem cell tech­nologies, Neuralstem is growing regionally specific cells that are already suited to the task prescribed to them once transplanted into the CNS. In spinal cord indications, for instance, the company will be using human NSI-566 spinal cord stem cells only. Additionally, once inside the body, Neuralstem cells also do not become any cell other than that to which they are fated.

There are two primary ways that these cells can provide therapeutic effects.
Create: The transplanted cells may help create new circuitry
Express: The transplanted cells may express factors that protect existing cells

We believe that Neuralstem’s cells do both.

In preclinical work conducted at major research centers across the U.S., Neuralstem cells integrated and made synaptic contact with the host. The cells also expressed one or more growth factors. These are special chemi­cals that the CNS uses to operate and thrive. Many of these growth factors are protective of cells. View published papers here: 1, 2, 3.

Neuralstem’s transplanted cells survive in patients and integrate into the host tissue, creating new circuitry and expressing growth factors. This dual function is important. In spinal cord injury, for instance, the company hopes to create circuitry that will help signals from the brain get to where they need to go. In many indications, the goal is to slow down or halt the degeneration of cells caused by disease, or by injury, by expressing neuroprotective growth factors into the system.

Delivering the Cells into the Spinal Cord and Brain Safely and Effectively

A vital component to the Neuralstem cell therapy platform is the delivery of the cells directly into the gray matter of the spinal cord, where they can protect and integrate with the patient’s spinal cord neurons.

Neuralstem’s proprietary Spinal Cord Delivery Platform and Floating Cannula were designed specifically by Neuralstem’s ALS trial neurosurgeon, Nicholas M. Boulis, MD, for the world’s first intraspinal delivery of stem cells. The safety of the device was first reported in data presented at the American Association of Neurologists’ 2011 Annual Meeting, and its safety has since been repeatedly validated in the company’s completed two ALS clinical studies, in a total of thirty patients, which met primary safety endpoints. In addition to ALS, NSI-566 is also in a Phase I trial in chronic spinal cord injury at UC San Diego School of Medicine. You can view this breakthrough medical device in surgery here.

The Spinal Cord Delivery Platform and Floating Cannula will be utilized to deliver Neuralstem cells in the spinal cord safely and effectively for myriad diseases and injuries. Expected to be the standard in the industry and research community for intraspinal procedures, Neuralstem is licensing the breakthrough cell therapy device to industry and academia.

Delivery of neural stem cells into the brain will be accomplished using well-established stereotactic injection procedures. NSI-566 is in clinical development to treat ischemic stroke utilizing one-time treatments of these intracerebral injections to safely transplant cells near the stroke lesions of ischemic stroke patients.

http://www.neuralstem.com/cell-therapy

Heroin

Heroin (diacetylmorphine) is a semisynthetic narcotic derived from the opium poppyPapaver somniferum. It was first synthesized in 1874 and was originally marketed as a safer, nonaddictive substitute for morphine. Soon after its introduction, heroin was realized to be clearly as addictive as morphine, prompting the US government to institute measures to control its use. By 1914, the Harrison Narcotics Act prohibited the use of heroin without a prescription. In 1920, the Dangerous Drugs Act prohibited the use of heroin altogether, thus driving it underground.

Afghanistan remains the world’s largest cultivator of opium, accounting for more than 60% of the world’s opium poppy cultivation. Central and South America—the main suppliers of opium products to the North America—account for about 7% of the world’s opium poppy cultivation.

In its pure form, heroin is a white powder with a bitter taste. However, samples are frequently mixed with other substances so dealers can maximize their profits. Because of these impurities and additives, street heroin samples have different purities and may appear in various hues, ranging from white to dark brown. Heroin is occasionally sold as a black, tarry substance, especially when crude processing methods are used to manufacture it. Heroin samples from South America appear to have the highest purity, reaching at times more than 70% purity.

Heroin remains one of the most frequently abused narcotics in the United States. It may be injected intravenously (“mainlining”), snorted, or smoked. The presence of impurities may limit its absorption through mucous membranes, thus limiting its “rush” and “high” when sniffed or snorted.

Heroin poisoning occurs most commonly when an individual accidentally overdoses on the drug. Poisoning may also occur in a “body packer,” “body pusher,” or “body stuffer.” Body packers, also called “mules,” are people who swallow and pack their GI tracts with bags of heroin in order to smuggle the illegal drug from one country to another. Body pushers conceal the drugs in their rectum and/or vagina. In both of these groups, the drugs are carefully packaged for safe passage, but poisoning occurs if the packages rupture. Body packing or pushing should be suspected in persons who are found unconscious at airports, during international flights, or soon after a trip to endemic countries.

Body stuffers, on the other hand, are people who ingest all the drugs in their possession in order to conceal the evidence from the police. Because these packages are typically not designed for safe GI transport, they easily rupture and frequently cause poisoning.

Heroin is a highly addictive semisynthetic opioid that is derived from morphine. When used intravenously, it is three to five times more potent than its parent compound and is able to modulate pain perception and cause euphoria. Similar to morphine, heroin and its metabolites have mu, kappa, and delta receptor activity. In general, stimulation of the mu receptors results in analgesia, euphoria, CNS depression, respiratory depression, and miosis. Stimulation of the delta and kappa receptors also results in analgesia, but the kappa receptors are mostly involved in spinal analgesia.[1]

heroin

Heroin, similar to morphine and other narcotics, reduces the brain’s responsiveness to changes in carbon dioxide levels and hypoxia, thus resulting in respiratory depression. It also reduces peripheral vascular resistance (resulting in mild hypotension), causes mild vasodilation of the cutaneous blood vessels (resulting in flushing), and stimulates histamine release (resulting in pruritus).[1]

Heroin’s inhibitory effects on baroreceptor reflexes result in bradycardia, even in the face of hypotension.[1]

Finally, heroin decreases gastric motility, inhibits the effect of acetylcholine on the small intestine, and diminishes the colonic propulsive waves, resulting in prolongation of gastric emptying time by as much as 12 hours, with consequent constipation.[1]

The onset of action, peak effects, and duration of action vary with the different methods of heroin use. Onset of action occurs within 1-2 minutes with intravenous injection and within 15-30 minutes with intramuscular injection. Heroin’s peak therapeutic and toxic effects are generally reached within 10 minutes with intravenous injection, within 30 minutes with intramuscular injection or when snorted, and within 90 minutes when injected subcutaneously. Analgesic effects generally last 3-5 hours.[1]

Intravenously injected heroin creates a rush, or a sensation of intense pleasure, that begins within 1 minute of the injection and lasts from 1 minute to a few minutes. This rush is followed by a period of sedation that lasts about an hour. The initial rush is likely due to heroin’s high lipid solubility and rapid penetration to the brain. The half-life of heroin is 15-30 minutes.[1]

Heroin is rapidly converted to 6-monoacetylmorphine (6-MAM) by the liver, brain, heart, and kidneys and may not be detected in the blood at the time of blood draw. 6-MAM is then converted to morphine. Morphine is metabolized by the liver and excreted as a glucuronide product or in its free form by the kidneys. Morphine’s half-life is considerably longer than heroin’s (ie, 2-3 h). A small amount of unchanged 6-MAM is excreted in the urine for up to 24 hours after heroin use. Because 6-MAM can originate only from heroin, its detection in the urine can mean only that the patient used either heroin or 6-MAM

http://emedicine.medscape.com/article/166464-overview

 

Opioid prescription and cancer in UK

466% increase in opioid prescribing

In England, the growing use of buprenorphine, oxycodone hydrochloride, and morphine sulphate increased annual costs for these three drugs by more than £10 million (US$12.98 million) between 2002 and 2013. Also, dispensing data reported by the UK National Health and Social Care Information Center show a 466% increase in opioid prescribing between 2000 and 2010.

However, in cancer patients, opioid prescribing has not increased as dramatically and represents only 16.1% of all opioid prescriptions issued in the United Kingdom, the authors say.

Reviewing a centralized UK prescriptions database, the authors extracted all prescriptions for analgesics issued to each patient in the cohort during the 12 months before death.

43.3% for strong opioids

 The team found that 96,810 analgesic prescriptions were issued to 4610 patients in the study; 31.5% of all prescriptions were for nonopioids, 25.2% for weak opioids, and 43.3% for strong opioids.

The team also analyzed the extent and duration of strong-opioid treatment with respect to clinical and patient characteristics.

Older age

Strong-opioid prescribing was not influenced by cancer type, duration of illness, or sex but was adversely influenced by older age, they report.

 Patients aged 60 years or older were between 1.7 and 4.3 times more likely to receive a late prescription of a strong opioid in comparison with patients younger than 50 years.

Compared with patients who died in a hospice, those who died in a hospital were 60% less likely to receive a strong opioid in primary care before admission (relative risk ratio, 0.4; 95% confidence interval, 0.3 – 0.5; P < .01).

60 weeks survival

“Median survival for our sample from diagnosis was 60 weeks, suggesting that most opioid prescribing in fact occurred late in the trajectory between diagnosis and death, regardless of cancer duration,” summarized coauthor Mike Bennett, St. Gemma’s Professor of Palliative Medicine, University of Leeds, in a press statement.

Dr Ziegler also pointed out that more than 90% of all patients in the cohort had received some form of cancer treatment. “Therefore, it was not the absence of a cancer diagnosis or poor engagement with cancer services that hindered timely access to an opioid,” she said.

Number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents

Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents,” write Dr Califf and coauthors Janet Woodcock, MD, and Stephen Ostroff, MD, also from the FDA. “Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable. As the public health agency responsible for over-sight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions. We are committed to action, and we urge others to join us.”

Opioid Pathophysiology

Activation of opioid receptors results in inhibition of synaptic neurotransmission in the central nervous system (CNS) and peripheral nervous system (PNS). Opioids bind to and enhance neurotransmission at three major classes of opioid receptors. It is also recognized that several poorly defined classes of opioid receptors exist with relatively minor effects.

The physiological effects of opioids are mediated principally through mu and kappa receptors in the CNS and periphery. Mu receptor effects include analgesia, euphoria, respiratory depression, and miosis. Kappa receptor effects include analgesia, miosis, respiratory depression, and sedation.

Two other opiate receptors that mediate the effects of certain opiates include sigma and delta sites. Sigma receptors mediate dysphoria, hallucinations, and psychosis; delta receptor agonism results in euphoria, analgesia, and seizures. The opiate antagonists (eg, naloxone, nalmefene, naltrexone) antagonize the effects at all four opiate receptors.

Common classifications divide the opioids into agonist, partial agonist, or agonist-antagonist agents and natural, semisynthetic, or synthetic. Opioids decrease the perception of pain, rather than eliminate or reduce the painful stimulus. Inducing slight euphoria, opioid agonists reduce the sensitivity to exogenous stimuli. The GI tract and the respiratory mucosa provide easy absorption for most opioids.

Peak effects generally are reached in 10 minutes with the intravenous route, 10-15 minutes after nasal insufflation (eg, butorphanol, heroin), 30-45 minutes with the intramuscular route, 90 minutes with the oral route, and 2-4 hours after dermal application (ie, fentanyl). Following therapeutic doses, most absorption occurs in the small intestine. Toxic doses may have delayed absorption because of delayed gastric emptying and slowed gut motility.

Most opioids are metabolized by hepatic conjugation to inactive compounds that are excreted readily in the urine. Certain opioids (eg, fentanyl, buprenorphine) are more lipid soluble and can be stored in the fatty tissues of the body. All opioids have a prolonged duration of action in patients with liver disease (eg, cirrhosis) because of impaired hepatic metabolism. This may lead to drug accumulation and opioid toxicity. Opiate metabolites are excreted in the urine. Impaired renal function can lead to toxic effects from accumulated drug or active metabolites (eg, normeperidine).

Long-acting opioids also may increase mortality from cardiorespiratory and other causes. In a retrospective cohort study between 1999 and 2012 of Tennessee Medicaid patients with chronic noncancer pain and no evidence of palliative or end-of-life care, prescription of long-acting opioids for chronic noncancer pain, compared with anticonvulsants or cyclic antidepressants, hazard ratios were 1.64 for total mortality, 1.65 for cardiovascular deaths, and 4.16 during the first 30 days of therapy.

opioids.JPG

Connie’s comments: Sublingual morphine is given to hospice seniors, who have less than few months to live. In the caregiving business, I saw how a droplet of this opioids behave similar to mercury. It arrests the muscles in the body.

http://www.medscape.com/viewarticle/869095#vp_2

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