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Thread: The Early SHOW, CBS (A transcript for the CBS interview-Melissa Holley)

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    The Early SHOW, CBS (A transcript for the CBS interview-Melissa Holley)

    Experimental Treatment for Spinal Paralysis
    February 27th, 2001
    The Early SHOW, CBS
    A transcript for the CBS interview

    Feb. 27 (CBS) Eight months ago, a car accident left 18-year-old Melissa Holley of
    Ridgway, Colorado, paralyzed, possibly for life. But a new experimental treatment
    is providing her some hope that she will walk again. Melissa Holley joins us from
    her home and Dr. Valentin Fulga, vice president of Proneuron Biotechnologies,
    the company in Israel that is conducting the clinical trial that Melissa is
    participating in, joins us from Israel.

    It's been 7 months since 18-year-old Melissa Holley received an experimental
    treatment for paralysis in Israel as part of an FDA-approved clinical trial. The
    results are promising for the young woman, who was paralyzed from the middle of
    her back down to her toes as a result of a car accident last year in June. Two of
    her vertebrae were crushed and her spinal cord was severely injured when her car
    flipped over on a wet road. She was driving alone to work. Part of the car landed
    on top of her. The diagnosis was bleak. Doctors didn't say that she wouldn't walk
    again, but they concluded that the paralysis was probably irreversible.

    Her father decided that that diagnosis would not be the final one. He spent 2 days
    and nights searching the Internet and found out about an experimental therapy for
    paralysis that was being done in Israel. But it had only been performed on rats.
    Melissa Holley became the first human to receive this treatment, which is called
    autologous activated macrophage therapy. The treatment involves using the
    patient's own white blood cells--drawn from skin and bone marrow--to regenerate
    the severed nerves in the spinal cord.

    On Thanksgiving Day, Holley started getting some feeling in a small part of one of
    her upper thighs. Since then, she has experienced more feelings in her legs and
    she can wiggle her toes. Doctors don't know how much improvement in her
    condition there will be as a result of this therapy. But what they have seen so far
    looks promising. The scientists involved in the study would like to be able to
    duplicate the success they have had with rats in humans. Fulga says that rats
    have been able to walk after receiving the treatment--not normally, but they were
    able to move their hind legs.

    Interview with Melissa Holley

    Melissa Holley wants to make more people aware of this clinical trial. She talks
    about the results that she has experienced from the therapy more
    enthusiastically than does Fulga. He says the results are encouraging, but he
    has to be very cautious not to overstate the results.

    Holley says that her accident was on June 25th. "I was on my way to work and I
    had to be there at 4 PM," says Holley. "It had been raining earlier and my wheel
    just caught on the side of the road." She says the car flipped over and a wheel
    landed on her T6 and T7 spinal vertebrae. "They found that I had a complete
    injury," she says. "I was paralyzed from the middle of my back on down. It
    became more evident that I was going to either start dealing with what I had,
    which was nothing, or look for some hope with this procedure. We learned it was
    a credible procedure, not just some guy in the middle of nowhere."

    Holley says that it was scary to be the first human to have this therapy.
    Especially when she got to Israel and they explained exactly what they were
    going to do. "They had only tried it on rats," she says.

    Holley describes how she gradually began to regain some feeling after receiving
    the therapy. "About 2 weeks after the surgery, one of the nurses came to give me
    a shot in my right thigh, and when she rubbed it down with the alcohol, there was
    a little feeling--about a half-dollar size--where I could feel the swab," she says.
    "From there on, week by week, I would get blurbs of feeling on my thighs first,
    more so up on my leg and then it worked downward. They [the feelings] started
    connecting in the larger areas, and then I started developing pain sensation in the
    right leg. If I pinch my right leg it hurts. If I pinch my left leg, I feel the tug of the
    skin, but not the pain.

    "Thanksgiving night was the first time I acknowledged any type of regain in
    muscle movement. I was just sitting in my room and I noticed that I was having a
    spasm, when your nerves shoot off randomly." She says she noticed that she
    could control a muscle in part of her thigh after the spasm subsided. At first she
    thought it was the spasm doing it. "After the spasm stopped, I put my hand on
    the inside of my thigh and tried to contract my muscle and I did. First, it was just
    my right side and then as the night went on I had my left inner thigh and my
    quads and I could wiggle my toes," says Holley.

    Holley says that she is starting to get some muscle movement back and the
    feelings that she is experiencing are great. Holley says that she can move her
    foot and toes up. "I have regained some of my abs and at night, I do some
    crunches--which are weak crunches, but they are crunches," she jokes.

    She says that she thinks of her father as "a life saver." "There was that aspect of
    time that something had to be done, and it had to be quick. The fact that he found
    something is like a miracle," she says.

    She credits Fulga for translating the therapy that was used for rats into use for
    humans. "Any advancements or changes in my condition are reported to him,"
    she says. "When I found out that I had the new movement I called him."

    Holley says it's unfortunate that this therapy is not being offered to patients with
    older injuries. She hopes that as more patients are found to participate in studies
    like this one, the possibility for helping people with older injuries will increase.

    Melissa Holley is very fortunate that her father quickly found out about this clinical
    trial on the Internet, because in this trial the patient has to be treated within 14
    days of injury.

    The Trial

    This study is in phase I of clinical trials. According to Dr. Dan Lammertse, the
    medical director at Craig Hospital in Denver that is tracking Melissa Holley's
    progress, the results of this feasibility study looks promising. "The scientific basis
    makes sense," says Lammertse. "It appears to have very low potential for
    adverse outcomes and complications, so it has a lot of inherent advantages. But
    the test is to provide this treatment to a number of people and to use the best
    scientific means to figure out if it has helped them." Lammertse says that if you
    take 100 people with a spinal cord injury, some will get better and some won't. "If
    you have an experiment like this," and you have a small number of people who
    are getting somewhat better, "it's hard to put it into perspective in the context of
    the natural course of recovery. We don't have a precise way of predicting recovery
    for an individual."

    Lammertse says that the people in the study have so far experienced a
    better-than-typical recovery, but at this point, it's hard to know where they will
    wind up in terms of how much they will be able to function.

    How It Works

    Macrophages are white blood cells that play a role in healing wounds and
    regenerating tissue. "When we are talking about spinal cord injuries, we are
    looking at nerves in the central nervous system and periphery nerves," says
    Fulga. "The difference between these two types of nerves is that nerves in the
    central nervous system don't re-grow by themselves and nerves in the periphery
    do." Fulga says the therapy that Melissa Holley received involves taking some of
    the macrophages from the periphery and putting them into the central nervous
    system so they can educate them to work. Fulga says that they help the nerve
    cells to regrow. "The macrophages in the central nervous system are scarce and
    lazy," he says.

    Fulga says that it's important to understand that macrophages do not turn into
    nerve cells, they just help the nerves to regrow. "They bring about an environment
    that is conducive for regeneration," he says. "So, in a nutshell, we take blood
    from the patient, we isolate the macrophages from a bit of the patient's skin, and
    bring them to Proneuron [the biotech company he works for]. We put them
    together and we culture them for approximately 1 day," says Fulga. "We take the
    macrophages and put them with the wounded skin, so we educate them. We
    then take the macrophages, which are now more mature and hopefully more
    effective, and we put them into a small syringe. The neurosurgeon injects them
    into the spinal cord and that's all."

    Doctors braced Holley's spinal cord with two steel rods before injecting 4 million
    macrophages, less than a thimbleful, into the injured area. She and her father
    spent 3 months in Israel.

    Interview with Dr. Valentin Fulga

    Holley had what we call a complete spinal cord injury. She had been diagnosed
    by her neurosurgeon in Grand Junction, Colorado, and her father approached us.
    She had no sensation and motor function below the level of injury. It was a little
    higher than the waist, from the middle of the back down, no feeling sensation or

    The term "autologous" pertains to the person himself, meaning we don't take
    tissue or blood from one person and give it to another. We take the patient's own
    cells and we use them. Macrophages are white blood cells and they exist
    everywhere in the body. We have them in the lungs, in the liver, of course in the
    blood, and also in the central nervous system and also in the peripheral nervous
    system. The central nervous system is the brain, the spinal cord, and the optic
    nerves. The peripheral is all the rest of the nerves in the body.

    Melissa Holley was a perfect candidate for this study. She met all of the criteria.
    Candidates for the study have to be acute patients, within 14 days from the injury.
    We don't know if a longer period will be suitable. The reason for these 2 weeks as
    a window of opportunity is based on the work that we have had in animal studies
    so far. We know that we can treat animals after 14 days from the injury, so that's
    what we have tried in humans. Every day many people call me and email me
    asking for treatment. Unfortunately, I cannot give them any treatment. First of all,
    I am not the neurosurgeon, but that's not the issue. It's very difficult to find people
    within the 14 days of injury who know about the study and are in good-enough
    condition to travel.

    Secondly, the level of injury is important. People who are too high or too low are
    not eligible because at this stage we cannot take patients that have respiratory
    problems, and we cannot treat patients that are injured above the C5 vertebrae,
    the fifth vertebrae of the neck.

    I don't think there is anyone in the world that really knows what is going to be for
    Melissa. It's a novel therapy, and she is the first one to receive it. We know what
    we got from rats. At least until now, we see a resemblance in the recovery that
    we saw in rats, in terms of . . . they were able to walk.

    Holley has gotten back some motor function and with some physical therapy she
    may be able to improve more, but we don't know. On the average, the animals
    recover after 12 weeks. Think of the rat whose spinal cord is less than half a
    centimeter in diameter and think of the human who has a spinal cord on average
    1 centimeter or 1.2 centimeters in diameter. The amount of tissue that has to
    regrow is significantly larger for a human. In general, what is suggested in the
    literature is that it will take three to four times longer in a human in terms of a
    spinal cord injury. We can extrapolate that what happens in a rat in 3 months,
    may happen in a human after something like 9 to 12 months, but we don't know
    for sure.

    We are encouraged by the results of the three patients in the study. At this
    stage, we have submitted the clinical study to the FDA, and we asked for some
    changes in the manufacturing stage. We have to wait for the FDA decision to
    enroll more patients because we want to comply with all of the regulatory
    requirements. They are looking for about eight participants in the first phase of
    this study. The Israeli Ministry of Health is also monitoring this study.

    She is a hero. She and her father are heroes. I thought to myself, "Would I be
    able to do this?" To go to another country and have an experimental treatment? I
    don't know. It's amazing.

  2. #2
    Senior Member mk99's Avatar
    Join Date
    Jul 2001
    toronto, canada

    FDA approval

    If I remember correctly, this procedure was approved by FDA for US trials as well.

    Is anyone planning on doing anything with this in US?

  3. #3
    Published on 06/14/2001

    Progress made in healing injured spines

    By Megan Goldin

    JERUSALEM, Jun 14 (Reuters) - Israeli doctors said on Thursday a clinical trial on paraplegics had shown success at repairing severed spinal cords and restoring movement to paralyzed people.

    Melissa Holley, an 18-year-old American, underwent the treatment in Israel last year after she was left a paraplegic following a car accident.

    Twelve months later, her doctor said, she has regained movement in her toes and legs and has bladder control, improving her quality of life and reducing the chances of a urinal infection--a common cause of death among paraplegics.

    Holley became the first person to undergo the treatment--previously tested only on rats--after she crushed two vertebrae and severely damaged her spinal cord in a car accident in the United States.

    "She couldn't move. She couldn't feel anything," said Dr. Valentin Fulga, whose company, Proneuron Biotechnologies (Israel) Ltd, developed the treatment.

    He said Holley began regaining sensation several months after white blood cells called macrophages were injected into her spinal cord at Tel Hashomer hospital near Tel Aviv last July.

    The body uses macrophages to heal wounds and regenerate tissue.

    "She recovered very significant motor function in her legs, although she is not yet walking," Fulga said.

    Holley's father came across the Proneuron Web site, which offers to bring paraplegics to Israel for the experimental treatment.

    Fulga wanted, in first-stage trials, to test the method on at least five more people who had "no sensation, no motor function below the site of the injury."

    The treatment is based on research by Professor Michal Schwartz from Israel's Weizmann Institute of Science, who found that by injecting treated macrophages in rats she was able to restore nerve function about 60% of the time.

    Fulga said the scarcity of macrophages in the central nervous system is a main reason severe spinal injuries are permanent.

    He said Schwartz's research and the initial trials have shown that macrophages activated to treat wounds and injected in the spinal column slowly begin to repair nerve fibres.

    Dr. Nachson Kenoller, a neurosurgeon who has performed the procedure on three people, said the spinal cord and brain had been considered areas where regeneration was impossible.

    "We are talking about regeneration of the spinal cord, which has never been recorded in the past," Kenoller told Reuters.

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