Other Therapeutics

On November 6, 2005, in Therapeutics
The Advisory Board sees a revolution in spinal surgery, though not for another 15 years. The acceleration in the understanding of genetic and proteomic mechanisms of cells, perhaps more evident in this issue of Health Futures Digest than in any previous one, makes 15 years seem somewhat pessimistic.

For sure, revolutions in other therapies will come much sooner. In prosthetics, for example, a new artificial hand mimics a real hand to near-perfection. Give it built-in eyes and it could turn its wearer into a brain surgeon, or a concert pianist, though we concede, that could indeed take 15 years.

Prosthetics R&D will be boosted over the next four years by US$35 million of Pentagon spending, occasioned by the (undisclosed number of) US military casualties in Iraq.

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Thanks to advances in brain implant devices, neurosurgery could be “the next cardiology,” say analysts. The tour de force of brain implants — the Braingate brain-machine interface chip — is entering a new round of clinical trials, this time involving ALS patients.

All implants may be improved by the addition of diamond-like carbon coatings, and assistive or replacement heart implants (in growing demand as the technology improves and the boomers age) may be by a device to improve their hemodynamic characteristics.

Other news of breakthrough therapies:

  • Skin cells taken from an aborted fetus were successfully used to heal second and third-degree burnsin eight children.
  • The sizeable industry that has developed around baldness, ranging from toupes to hair follicle implants, owes much of its existence to a gene mutation. A way to fix the mutation and reverse its effectshas been discovered.
  • A vaccine for melanomahas protected more than 60 percent of mice in a trial. But one for cervical cancer is even better, proving 100 percent effective in humans.
  • Antibiotic-resistant “superbugs” may have met their match, at least until they figure out a way around new compounds.
  • Genetically-engineered chickens are laying eggs containing especially potent human monoclonal antibodies.
  • The nose offers a minimally invasive endoscopic route to the brain for surgery, and one hospital has built an entire OR dedicated to the new technique.

Non-invasive Spinal Surgery on the Horizon

Source: The Advisory Board (2005): “Future of spinal surgery, part 3: Protein injections, gene therapy could one day heal degenerative intervertebral discs.” September 2. Available via subscription.

Protein injections, gene therapy, and cellular transplantation are showing early promise in restoring intervertebral discs and preventing further disc degeneration. If successful, such treatments could revolutionize the landscape of spinal surgery by allowing surgeons to treat the root causes of intervertebral disc degeneration instead of simply targeting its symptoms, as is the case with spinal fusion and artificial discs. But the Advisory Board’s Technology Insights analysts predict that biologic solutions for degenerative disc treatment likely will not reach clinical practice for at least 15 years.

Artificial Hand

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British scientists have developed an ultra-light prosthetic hand that can mimic the movement in a real hand better than any currently available. The prototype has 6 sets of motors and gears allowing independent movement in each of the four fingers and thumb, enabling the hand to hold objects — a ball, a key, a hammer, for example — in the same way a real hand does. The hand is connected to and controlled by muscles in the arm.

At 400g, the carbon-fiber hand is 20 percent lighter than the average real hand. Its thumb is the first artificial opposable thumb. It has two motors instead of one so it can rotate and flex, enabling it to oppose (touch) each of the fingers in the hand.

The next step is to incorporate piezo-electric pressure and touch sensors in each digit, so the hand can hold objects without either crushing them or letting them slip.

Intelligent Artificial Hand

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German researchers have developed an artificial hand that learns through imitation. It could lead to advances in robots and prosthetics, though the current research is at a very basic science stage. The hand was given its own video eyes to see its environment and the instructor’s gestures, which it could then mimic. Potential applications include surgery, the researchers suggest.

Boost for Prosthetics

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“During the next four years,” reports USA Today, “the Pentagon will spend almost $35 million to develop improved artificial arms, aiming for one a Defense Department report says will ‘feel, look and perform’ like a real arm guided by the central nervous system.” The Defense Advanced Research Projects Agency will award the contracts.

More than a quarter of the 337 US troops who have lost at least one limb in Iraq or Afghanistan to date are hand or arm amputees. The technology developed under the new research should eventually trickle down to some of the 1.2 million Americans missing at least one limb.

Deep Brain Stimulation Market to Grow

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The medical device industry’s 800-pound gorilla, Medtronic, has purchased a company that makes a device used to implant deep-brain stimulation devices, “a category that industry trackers see as the next blockbuster product line for medical technology companies,” reports the Star Tribune.

More than 30,000 Parkinson’s, essential tremor and dystonia patients have received Medtronic’s Activa Therapy device in recent years, and Medtronic believes its potential extends to other neurological disorders such as epilepsy, obsessive compulsive disorder and depression, as well.

The newspaper cites Wall Street analysts who predict worldwide neurological device revenue of $2.2 billion this year rising to $4.6 billion in 2010. One described it as the “next cardiology” in medical technology. The acquired company’s CEO said “Pacing of the brain could be a much larger market than pacing of the heart.”

The device acts somewhat like a GPS, allowing the surgeon to steer a deep-brain stimulator’s electrodes safely through the brain to the stimulation target, avoiding critical structures whose damage could lead to paralysis and areas where hemorrhages could occur.

Brain Chips Advance

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Cyberkinetics Neurotechnology Systems Inc. has begun recruiting ALS patients for the second set of clinical trials of the BrainGate chip, which interfaces with neurons in the brain and converts their signals to computer-readable form. The goal is to enable patients to control wheelchairs, computer keyboards, and other devices just by thinking, while those devices put the thoughts into action.

The first trial, begun last year, involves only two patients, who have spinal cord injuries. With reportedly promising results from one of the cases, the US Food and Drug Administration has approved the second trial.

Other companies also working on brain-machine interface chips include Neural Signals Inc., and Boston Scientific Corp. (through its US$740 million purchase of Advanced Bionics Corp., which makes implantable hearing aids that connect to the auditory nerve and electrical devices that stimulate the spine to counter pain.)

Liberating Technologies Inc. recently collaborated with the Rehabilitation Institute of Chicago and Northwestern University to create a pair of prosthetic arms for an amputee, and the Rehabilitation Institute has begun recruiting patients for BrainGate, presumably to interface with the prosthetic limbs.

DLC for Artificial Joint, Vessel Coatings

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Scientists at Britain’s Brunel University have developed a way to coat medical implants with a diamond-like carbon (DLC) material to make them harder wearing, reduce friction, and more resistant to corrosion. The coating could also help reduce infections due to superbugs such as MRSA (methicillin resistant Staphylococcus aureus).

Unlike diamond and other coating materials, DLC can be applied at temperatures low enough to be used on plastics and not just metals and ceramics. [Plastic implants would be much easier and less expensive to manufacture — Ed.] DLC is also biocompatible and does not cause blood to coagulate. The researchers have also developed DLC coatings for catheters and implants that penetrate the skin. The DLC also prevents colonization of the tissue by MRSA and other bacteria.

They are also developing DLC coatings to line hydrated collagen, a natural protein found in the body, which can be used to construct synthetic bypass arteries. The collagen is more readily accepted by the body, and the DLC not only allows blood to flow without causing it to clot, but also protects collagen patch grafts from degradation by the acidic or alkaline chemistry of the body.

Improved Heart Implants

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A “Particle Image Velocimetry” (PIV) system designed to improve aircraft aerodynamics is now being applied to the hemodynamics of medical implants such as heart valves and pumps. The European SMART-PIV project aims to overcome shortcomings in the present methods of estimating hemodynamic effects, such as coarse-grained ultrasound scans or lengthy, costly, and imprecise in vivo animal trials.

Better-designed implants would reduce the complications common among implant patients, which in turn would reduce costs while improving outcomes and patients’ quality of life.

The technology consists of ultra-thin laser light sheets that capture images of the fluid dynamics of blood flowing through implanted devices, and software that analyzes the images to show such things as high velocity gradients that can cause cell damage and low velocity gradients that can cause thrombosis or coagulation.

The prototype system can currently perform such analyses in vitro in about a day, and within two-to-three hours as computing power increases over the next year or two. A commercial device will probably be “in use within the next few years,” according to the researcher.

Fetal Cell Burn Therapy

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Skin cells grown from an aborted fetus have healed second- and third-degree burns in eight children in Switzerland. The fetal tissue promoted growth of the patient’s own skin cells over the burns in about two weeks, eliminating skin grafts, scarring, and tissue contraction, and making dressing changes easier and less painful.

The cells came from a 1.5 inches square patch of skin taken, with the mother’s consent, from a 14-week aborted male fetus. The cells were cultured and placed onto collagen sheets, which were then cut into 3 1/2 by 5 inch pieces, Four pieces each were placed on 10-day-old burns in the eight children. The fetal-cell material eventually disappeared — it was not incorporated into the regenerating skin.

The patients were followed for one to two years. There was “total recovery of mobility, especially in hands and fingers.” There was some color change in some areas, but the overall appearance was reported to be good.

The researchers calculated that the small piece of fetal skin taken in this case could ultimately produce more than 2 million of the squares that were put on the burns, enough to treat thousands of burn victims.

Hope for the Hairless

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Johns Hopkins University researchers have used a protein encoded by a gene called “Hairless” in hair progenitor cells to restore follicle growth in genetically hairless mice. In humans and mice with mutations in the Hairless gene, hair growth is initially normal, but once hair is shed, it does not grow back. After the researchers induced Hairless to express in the appropriate progenitor cells, bald mice grew thick fur.

Cancer Vaccines

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A University of Florida scientist has created a vaccine that provided almost complete protection against melanoma (a skin cancer) in mice. The vaccine uses dead melanoma cells and a super-antigen to stimulate the immune system. The vaccine protected more than 60 percent of the mice given a lethal dose of melanoma and 80 percent of those given a second lethal dose six months later.

That vaccine will require several years of human clinical trials before it could reach the market, but a vaccine against human papillomavirus (HPV) — by far the leading cause of cervical cancer — has passed clinical trials with flying colors. The vaccine, Merck’s “Gardasil,” was 100 percent effective in tests in more than 12,000 women in 13 countries. All of those who received the drug remained disease-free after being followed an average of 17 months.

Antibiotics for Superbugs

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Notre Dame University researchers have synthesized three new antibiotics to treat the “superbug” methicillin-resistant Staphylococcus aureus (MRSA), based on cephalosporin, a close relative of penicillin. In tests, the compounds successfully killed vancomycin-resistant MRSA. One of the compounds has begun Phase I clinical studies.

Human Antibodies Made in Chicken Eggs

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Long used to produce flu vaccines, chicken eggs are now being used to produce human monoclonal antibodies, therapeutic proteins of which more than 25 are approved for human use, in cancer and other diseases, with more on the way.

Monoclonal antibodies produced in this way demonstrated a 10- to 100-fold increase in cell-killing ability compared to those produced by conventional cell culture approaches.

Brain Surgery Through the Nose

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A new “Endonasal Surgical Suite” at the University of Pittsburgh Medical Center is designed solely for endoscopic transnasal brain surgery remove brain tumors. For patients, it means shorter hospital stays and less trauma and risk than the traditional alternative, invasive craniotomy.

 

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