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keep your socks on you'll be all right

2
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there over the last couple years has

3
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been quite little information in the

4
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press about traumatic brain injury most

5
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of it related to reports on X football

6
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players who is a consequence of repeated

7
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hits to the head have become depressed

8
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often times homeless and then commit

9
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suicide and it's probably good that

10
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there's some attention being brought to

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this problem although it should be

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pointed out right off the bat that the

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football players or the athletes are not

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the major targets for this disease there

15
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are about a one and a half to two

16
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million cases a year in this country of

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traumatic brain injury 50,000 deaths

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80,000 disabled in the military there

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another 300,000 that doesn't include

20
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people in the VA but the leading causes

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are not athletic injuries by far and

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away at the leading causes are accidents

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falling off your bicycle or falling off

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the roof or whatever it might be

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interestingly enough assaults come in

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second domestic assaults and then

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athletics there are two types of

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traumatic brain injury the experts say

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that these are separate diseases I'm not

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convinced of it but the there are acute

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and chronic forms of traumatic brain

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injury and as indicated in the slide the

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acute are injuries such as concussions

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head bumps they don't have to be

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associated with any period of

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unconsciousness they heal rapidly and

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spontaneously but multiple injuries of

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this sort can lead to problems later on

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and it or it or it is these acute form

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these cute injuries that are as a focus

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of most of the research being done now

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both in this country and otherwise and

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we'll see in a minute why that is

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in contrast the chronic form of

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traumatic brain injury is a result of

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multiple insults or sometimes just one

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really serious one and I have these

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first couple or three dot points just as

49
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an example of different forms of

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injuries resulting in chronic

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00:02:18,070 --> 00:02:16,050
traumatic brain injury the first is one

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of the patients in our group who is a

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Hall of Fame lineman in the FN NFL he's

54
00:02:27,949 --> 00:02:25,770
up there because he's all being also

55
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being studied by a team from UCLA and

56
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the group of UCLA is not doing anything

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therapeutically for this fella like we

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are what they're doing is following the

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morphology of his brain over time seeing

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how it changes and see if they can

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really changes into the morphology to

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function but what's interesting about

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his situation is that as a prelude to

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starting the the UCLA study the

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investigators there did some

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calculations to find out just how often

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to dis guy get hit in his career it end

68
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up over 250,000 times this is from

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peewee football till until his

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retirement from the NFL so that's that's

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really repeated injury the next dot

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point there is a physician who was in

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the an auto accident not able to

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practice medicine anymore as a

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consequence of the accident we're

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getting him back to where I think he'll

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be able to do that again but again one

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serious accident he's in trouble and

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we'll come back to these these guys in

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in a few minutes the third one is

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another physician who was riding her

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horse one day the horse reared up threw

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her off she landed on her head and that

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was it for her now the problem and one

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of the real couple of the reasons why

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there is less work being done with the

87
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chronic form of disease and the acute is

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that there are no biomarkers for the

89
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chronic form there's nothing you can

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look at in the serum the blood urine or

91
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anything of that sort to get an idea of

92
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disease progression or stability or

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alterations as a consequence of therapy

94
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and likewise there are no standard

95
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standardized animal models which again

96
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for the investigators make things makes

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things a little bit tougher so just a

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nutshell summary of what we're doing for

99
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these patients is we're using an

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oxidized form of streptomycin oh and

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streptomycin Oh is a toxin that's

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produced by

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group a beta hemolytic streptococcal

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that's a mouthful but that's the strep

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to cause a strep throat and it's this

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exotoxin the causes as a pain of strep

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throat we oxidize it so it's no longer

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toxic and it has some absolutely unique

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biological activities as a consequence

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of the oxidation we've used it

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anecdotally and in a couple controlled

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studies clinically to treat a wide

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variety of scars

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everything from idiopathic pulmonary

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fibrosis to cardiomyopathy polycystic

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kidney acne scars adhesions trauma

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induced scars and so forth and these are

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all collagen related problems and we

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know that the SLO our product is a

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potent product for regulating collagen

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deposition it's also a potent

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anti-inflammatory agent we'll see why

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that's important it also down regulates

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mmp9 which doesn't mean a whole lot to

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most people I suspect but that is a gene

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that produces a protein that is

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associated with a wide variety of

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chronic disorders and over the last

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eight or nine years over seven billion

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dollars has been spent by the

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pharmaceutical industry to find products

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that down regulate that gene there are

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several of those products have come to

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Phase three trials they're all toxic

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this one is not we know that slo acts as

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a very potent signal to inhibit scar

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formation in an acute scar in an acute

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situation so if you get a bad cut for

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example take SLO sublingually or even

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rub it on a scar will not form instead

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there'll be a stimulation of what are

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called keratinocytes that will move into

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the wound you'll heal without a scar in

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old wounds the SLO upsets the balance

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between collagen which is the scar

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tissue and collagenase which is a an

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enzyme that breaks down collagen and

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that imbalance goes in favor of

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collagenase so it starts to break down

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old scars and that old scar is replaced

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by more vital tissue so we know the SLO

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acts on both internal and external scars

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we didn't know if I'd work on traumatic

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brain injury because there's no collagen

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in

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different system we did this little

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study with some investigators at Harvard

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Medical School in Boston Children's

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Hospital this is a bear model it's a

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it's a standardized mouse model for

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looking at acute traumatic brain injury

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and what happens here if I can find this

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woops sorry sorry sorry let's get back

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to where we belong

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and see if I can find this little dot

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there we go what we do is put the

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animals in a restrainer and hit them on

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the head with a pneumatic punch and you

169
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can measure the strength of the punch

170
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and the location wonderful technology

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00:07:34,910 --> 00:07:32,700
the Sham animals tease Omiya the Sham

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animals I'm not going to use the pointer

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anymore the Sham animals are put into

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the restrainer but are not injured the

175
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next group the middle group the c-h-i is

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just in the strain of mouse those

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animals are put into the restrainer are

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bopped once in the head and then they

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are treated with the vehicle which is a

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PBS phosphate buffered saline

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the third group punched in the head in

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the restrainer and treated with SLO and

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00:08:03,290 --> 00:08:00,330
then what we want to do is measure

184
00:08:05,420 --> 00:08:03,300
memory loss and ability to recovery

185
00:08:07,250 --> 00:08:05,430
short-term memory so what you're seeing

186
00:08:09,650 --> 00:08:07,260
here again without the pointer that a

187
00:08:12,140 --> 00:08:09,660
lot of most line as the green indicates

188
00:08:14,900 --> 00:08:12,150
are the Sham controls and you can see

189
00:08:18,640 --> 00:08:14,910
that one day after the injury it takes

190
00:08:21,950 --> 00:08:18,650
them about 27 or 28 seconds to find a

191
00:08:23,660 --> 00:08:21,960
submerged island in a little pond that

192
00:08:24,770 --> 00:08:23,670
they will swim to and stand on to get

193
00:08:27,290 --> 00:08:24,780
out of the water so they can breathe

194
00:08:29,330 --> 00:08:27,300
easily alright so that's the idea then

195
00:08:30,530 --> 00:08:29,340
every day for five days they are put

196
00:08:31,940 --> 00:08:30,540
back in the pond and what you're

197
00:08:34,130 --> 00:08:31,950
measuring is how long does it take for

198
00:08:36,050 --> 00:08:34,140
them to find the island and you can see

199
00:08:36,860 --> 00:08:36,060
that by day five they're down to five or

200
00:08:38,300 --> 00:08:36,870
six seconds

201
00:08:40,790 --> 00:08:38,310
they found the spot their short-term

202
00:08:43,460 --> 00:08:40,800
memory is is great that's the control

203
00:08:45,050 --> 00:08:43,470
that had no injury the next line is the

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00:08:47,810 --> 00:08:45,060
black one that goes up and down those

205
00:08:50,210 --> 00:08:47,820
are the animals that are injured and

206
00:08:52,340 --> 00:08:50,220
then treated with just the vehicle you

207
00:08:55,070 --> 00:08:52,350
can see that the injury causes an

208
00:08:57,380 --> 00:08:55,080
incredible increase in length of time

209
00:09:01,460 --> 00:08:57,390
on day one to find that island they're

210
00:09:03,290 --> 00:09:01,470
up at around 47 48 seconds they do very

211
00:09:04,580 --> 00:09:03,300
nicely in day 2 they come down to about

212
00:09:05,030 --> 00:09:04,590
half the time but they don't get any

213
00:09:06,860 --> 00:09:05,040
better

214
00:09:08,690 --> 00:09:06,870
that's as that's as good as it's going

215
00:09:11,020 --> 00:09:08,700
to get and then the treated animals you

216
00:09:13,820 --> 00:09:11,030
can see the Deana was treated with SLO

217
00:09:15,320 --> 00:09:13,830
come down to by day five they're

218
00:09:19,820 --> 00:09:15,330
starting to come pretty close back to

219
00:09:22,190 --> 00:09:19,830
altogether normal if we euthanize those

220
00:09:23,780 --> 00:09:22,200
animals take their brains out well I'm

221
00:09:25,100 --> 00:09:23,790
not going to spend time on any portion

222
00:09:27,110 --> 00:09:25,110
of this slide except the bottom right

223
00:09:30,350 --> 00:09:27,120
hand corner this is extremely important

224
00:09:33,320 --> 00:09:30,360
microglia cells are cells in the brain

225
00:09:35,720 --> 00:09:33,330
that on injury start to infiltrate into

226
00:09:37,250 --> 00:09:35,730
the area of injury and I'll tell you

227
00:09:40,150 --> 00:09:37,260
what that means in a second but you can

228
00:09:43,340 --> 00:09:40,160
see well we'll try this one last time

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00:09:45,770 --> 00:09:43,350
there we go you can see that microglia

230
00:09:48,320 --> 00:09:45,780
infiltration is a great deal greater in

231
00:09:50,600 --> 00:09:48,330
the animals that were treated with just

232
00:09:52,820 --> 00:09:50,610
the phosphate buffered saline that in

233
00:09:55,160 --> 00:09:52,830
either the sham controls or those that

234
00:09:57,110 --> 00:09:55,170
were treated with SLO the significance

235
00:09:58,730 --> 00:09:57,120
of that is the microglia are the

236
00:10:01,190 --> 00:09:58,740
predecessors to inflammation and

237
00:10:03,410 --> 00:10:01,200
inflammation is the predecessor to

238
00:10:05,120 --> 00:10:03,420
scarring scarring in the brain is going

239
00:10:08,060 --> 00:10:05,130
to be in the form of gliosis rather than

240
00:10:12,530 --> 00:10:08,070
collagen but the fundamental situation

241
00:10:13,790 --> 00:10:12,540
is the same and this you can't see quite

242
00:10:15,770 --> 00:10:13,800
as much as you might like but the ID

243
00:10:18,380 --> 00:10:15,780
here is that we're looking at a marker

244
00:10:21,140 --> 00:10:18,390
for microglia cells and there are more

245
00:10:23,360 --> 00:10:21,150
of those cells in the Sham controls more

246
00:10:25,160 --> 00:10:23,370
of these these bright points or dark

247
00:10:28,700 --> 00:10:25,170
points than there are in either the Sham

248
00:10:31,040 --> 00:10:28,710
or the SLO again confirmation that SLO

249
00:10:34,670 --> 00:10:31,050
is inhibiting microglial infiltration

250
00:10:36,350 --> 00:10:34,680
and likewise is preventing scarring in

251
00:10:39,650 --> 00:10:36,360
the brain of these mice in the acute

252
00:10:41,030 --> 00:10:39,660
type of disease now jump to the chronic

253
00:10:44,990 --> 00:10:41,040
situation we've got more of a problem

254
00:10:47,240 --> 00:10:45,000
again there's no animal model so what we

255
00:10:49,430 --> 00:10:47,250
have to do that one by the way the third

256
00:10:51,110 --> 00:10:49,440
point there are no biomarkers at all so

257
00:10:55,670 --> 00:10:51,120
we have to focus on performance outcome

258
00:10:58,130 --> 00:10:55,680
and we have done work with humans that

259
00:11:01,280 --> 00:10:58,140
have been damaged for anywhere from a

260
00:11:03,530 --> 00:11:01,290
few months to a few decades here's the

261
00:11:07,070 --> 00:11:03,540
sort of thing we see first just looking

262
00:11:08,829 --> 00:11:07,080
at kind of an overview of athletes from

263
00:11:15,199 --> 00:11:08,839
different

264
00:11:18,530 --> 00:11:15,209
treated and this is what we see usually

265
00:11:20,060 --> 00:11:18,540
within the first couple weeks we start

266
00:11:21,220 --> 00:11:20,070
to see improvement in terms of the

267
00:11:23,600 --> 00:11:21,230
headache dizziness and lightheadedness

268
00:11:25,430 --> 00:11:23,610
you'll remember a few slides back there

269
00:11:27,560 --> 00:11:25,440
was the one physician that got knocked

270
00:11:32,840 --> 00:11:27,570
off her horse and and landed on her head

271
00:11:35,269 --> 00:11:32,850
that gal had headaches 24/7 starting

272
00:11:37,040 --> 00:11:35,279
immediately after the fall lasting four

273
00:11:39,920 --> 00:11:37,050
five or six months before she started

274
00:11:42,019 --> 00:11:39,930
SLO therapy and after the second day she

275
00:11:42,769 --> 00:11:42,029
had no more headaches she hasn't had any

276
00:11:45,920 --> 00:11:42,779
sense

277
00:11:48,199 --> 00:11:45,930
so some signs and symptoms respond very

278
00:11:50,930 --> 00:11:48,209
quickly others not so not so fast

279
00:11:52,940 --> 00:11:50,940
short-term memory improves better the

280
00:11:54,769 --> 00:11:52,950
other physician that was mentioned in

281
00:11:56,389 --> 00:11:54,779
the previous slide the one who was in

282
00:11:59,090 --> 00:11:56,399
the car accident is no longer able to

283
00:12:01,610 --> 00:11:59,100
practice medicine had really significant

284
00:12:04,490 --> 00:12:01,620
damage to short-term memory and into

285
00:12:09,199 --> 00:12:04,500
cognition and focus that is all coming

286
00:12:13,100 --> 00:12:09,209
back now this that point way down here

287
00:12:14,960 --> 00:12:13,110
is perhaps the most important all of the

288
00:12:17,329 --> 00:12:14,970
patients that have been treated with SLO

289
00:12:22,430 --> 00:12:17,339
all of the chronically injured patients

290
00:12:25,639 --> 00:12:22,440
show decreased emotional volatility this

291
00:12:28,220 --> 00:12:25,649
is huge they are able to control their

292
00:12:30,920 --> 00:12:28,230
emotions better they are not lashing out

293
00:12:33,170 --> 00:12:30,930
they don't get frustrated they sleep

294
00:12:34,550 --> 00:12:33,180
better the consequences of those sorts

295
00:12:35,840 --> 00:12:34,560
of things are that they now can hold

296
00:12:37,730 --> 00:12:35,850
jobs they're going to get fired

297
00:12:39,680 --> 00:12:37,740
otherwise their interpersonal

298
00:12:42,319 --> 00:12:39,690
relationships are much better they're

299
00:12:44,930 --> 00:12:42,329
not getting divorced they can carry out

300
00:12:47,000 --> 00:12:44,940
normal activities of daily life without

301
00:12:49,220 --> 00:12:47,010
breaking windows or lashing out at their

302
00:12:52,730 --> 00:12:49,230
children or whatever might occur of that

303
00:12:54,980 --> 00:12:52,740
sort now I would like to have the

304
00:12:56,710 --> 00:12:54,990
liberty of looking at what happens we're

305
00:12:59,030 --> 00:12:56,720
just going to look at one patient

306
00:13:01,400 --> 00:12:59,040
follow-through with this one this is a

307
00:13:04,790 --> 00:13:01,410
lady that was in a serious car accident

308
00:13:07,670 --> 00:13:04,800
30 years before the start of SLO therapy

309
00:13:10,880 --> 00:13:07,680
okay serious accident to the extent that

310
00:13:11,300 --> 00:13:10,890
she needs 24/7 care from her family

311
00:13:14,600 --> 00:13:11,310
members

312
00:13:16,670 --> 00:13:14,610
I picked this patient not because she's

313
00:13:19,160 --> 00:13:16,680
better or worse responder to two-hour

314
00:13:22,290 --> 00:13:19,170
therapy but because her father is a nice

315
00:13:24,180 --> 00:13:22,300
enough guy to send reports in about her

316
00:13:27,750 --> 00:13:24,190
every once in a while so we can follow

317
00:13:30,150 --> 00:13:27,760
what's going on she was by the way 18 or

318
00:13:33,180 --> 00:13:30,160
19 years old at the time of injury so

319
00:13:34,830 --> 00:13:33,190
she's pushing 50 years old now here's

320
00:13:37,680 --> 00:13:34,840
what we're going to see first report

321
00:13:39,390 --> 00:13:37,690
comes in 40 days after the start of SLO

322
00:13:42,000 --> 00:13:39,400
therapy and look at the first thing the

323
00:13:43,680 --> 00:13:42,010
father said she's calmer that's just

324
00:13:46,080 --> 00:13:43,690
like the football players the boxers and

325
00:13:48,570 --> 00:13:46,090
all those there's a decrease volatility

326
00:13:51,570 --> 00:13:48,580
of her emotions that is very very big

327
00:13:53,700 --> 00:13:51,580
deal now she can follow the stock

328
00:13:54,810 --> 00:13:53,710
reports on the TV shark tank which I'm

329
00:13:57,090 --> 00:13:54,820
not sure what that is but I think it's a

330
00:13:58,170 --> 00:13:57,100
TV show isn't it whatever it is she can

331
00:14:01,110 --> 00:13:58,180
do it now and she couldn't do it before

332
00:14:03,000 --> 00:14:01,120
and she's reading more because of

333
00:14:05,010 --> 00:14:03,010
improved short-term memory just in 40

334
00:14:07,110 --> 00:14:05,020
days and understand she went about 30

335
00:14:09,180 --> 00:14:07,120
years without reading and the reason for

336
00:14:10,530 --> 00:14:09,190
that is at the bottom of the page she

337
00:14:12,780 --> 00:14:10,540
couldn't remember what was at the top of

338
00:14:16,740 --> 00:14:12,790
the page so just out of frustration she

339
00:14:18,570 --> 00:14:16,750
quit reading 70 days first thing the

340
00:14:20,340 --> 00:14:18,580
father says again she's calmer

341
00:14:25,020 --> 00:14:20,350
she's now for the first time enjoying

342
00:14:26,610 --> 00:14:25,030
physical therapy 106 days looked down

343
00:14:29,130 --> 00:14:26,620
there it says calm her again more

344
00:14:31,650 --> 00:14:29,140
positive attitude reading more for the

345
00:14:33,990 --> 00:14:31,660
first time she's taking care of herself

346
00:14:37,350 --> 00:14:34,000
first time in 30 years that she's

347
00:14:39,840 --> 00:14:37,360
worried about her appearance 141 days

348
00:14:41,700 --> 00:14:39,850
look at that this is really kind of fun

349
00:14:44,400 --> 00:14:41,710
of course she's calmer again we were not

350
00:14:47,580 --> 00:14:44,410
aware that she had had damage to her

351
00:14:49,500 --> 00:14:47,590
soft palate in this accident and the

352
00:14:51,150 --> 00:14:49,510
consequence of that was that she had

353
00:14:53,190 --> 00:14:51,160
difficulty speaking and was a great

354
00:14:55,110 --> 00:14:53,200
difficulty interpreting what she was

355
00:14:58,320 --> 00:14:55,120
saying so it was hard for her to talk

356
00:15:00,930 --> 00:14:58,330
and hard to understand what she was

357
00:15:03,330 --> 00:15:00,940
saying we got this report about clearer

358
00:15:05,340 --> 00:15:03,340
speech from her brother who hadn't seen

359
00:15:09,120 --> 00:15:05,350
her for about two-and-a-half months and

360
00:15:10,710 --> 00:15:09,130
the first thing he reported when the the

361
00:15:13,350 --> 00:15:10,720
patient and her father arrived at the

362
00:15:15,510 --> 00:15:13,360
brothers house was geez what happened to

363
00:15:19,470 --> 00:15:15,520
your speech and this is in a positive

364
00:15:21,270 --> 00:15:19,480
sort of way 173 days she can remember

365
00:15:23,100 --> 00:15:21,280
things I remember she had a short-term

366
00:15:24,990 --> 00:15:23,110
memory compromise to the point that she

367
00:15:26,700 --> 00:15:25,000
couldn't remember top of the page to the

368
00:15:28,470 --> 00:15:26,710
bottom of the page now she can remember

369
00:15:32,100 --> 00:15:28,480
what she had for breakfast today and

370
00:15:35,390 --> 00:15:32,110
yesterday some of us couldn't do that so

371
00:15:38,590 --> 00:15:35,400
that's a bit of a game she

372
00:15:41,150 --> 00:15:38,600
is commenting more and her comments are

373
00:15:42,920 --> 00:15:41,160
spontaneous they're insightful they're

374
00:15:45,530 --> 00:15:42,930
appropriate and they are better

375
00:15:49,160 --> 00:15:45,540
articulated so she's kind of pulling

376
00:15:51,170 --> 00:15:49,170
into society a little bit better 260z

377
00:15:55,220 --> 00:15:51,180
look it's still calmer that is still a

378
00:15:57,470 --> 00:15:55,230
big deal in the father's estimation this

379
00:15:58,850 --> 00:15:57,480
is very interesting about this improved

380
00:16:02,090 --> 00:15:58,860
organizational skills

381
00:16:06,500 --> 00:16:02,100
she had an art therapist come in for his

382
00:16:09,530 --> 00:16:06,510
first session after he left she composed

383
00:16:11,630 --> 00:16:09,540
an email to him that said very simply

384
00:16:14,300 --> 00:16:11,640
thank you very much for coming to my

385
00:16:16,910 --> 00:16:14,310
house I appreciated your being here

386
00:16:20,060 --> 00:16:16,920
we had fun I look forward to your coming

387
00:16:23,360 --> 00:16:20,070
again the big deal about this is that

388
00:16:27,140 --> 00:16:23,370
she was never before able to compose or

389
00:16:28,610 --> 00:16:27,150
send an email so that's the organization

390
00:16:31,910 --> 00:16:28,620
skill we're talking letter that her

391
00:16:33,740 --> 00:16:31,920
father is talking about and the sentence

392
00:16:36,020 --> 00:16:33,750
that the father was nice enough to share

393
00:16:36,980 --> 00:16:36,030
the email with me and it is really one

394
00:16:41,000 --> 00:16:36,990
that you would think would have been

395
00:16:42,770 --> 00:16:41,010
written by a I don't know seven or eight

396
00:16:45,140 --> 00:16:42,780
or nine year old very short sentences

397
00:16:47,270 --> 00:16:45,150
short choppy subject-verb so but you got

398
00:16:49,520 --> 00:16:47,280
the point across and that's brand-new

399
00:16:52,850 --> 00:16:49,530
and the kayaking and the water therapy

400
00:16:56,170 --> 00:16:52,860
are new to her and she initiated those

401
00:16:59,930 --> 00:16:56,180
with her friends nobody else did that

402
00:17:02,300 --> 00:16:59,940
289 days is the last report we have from

403
00:17:03,530 --> 00:17:02,310
her this is about 40 days ago so

404
00:17:05,180 --> 00:17:03,540
sometime in the next couple of weeks

405
00:17:06,710 --> 00:17:05,190
we'll hear another one and we'll receive

406
00:17:08,990 --> 00:17:06,720
another one but look what's happened

407
00:17:10,430 --> 00:17:09,000
still calmer for some reason or other

408
00:17:12,440 --> 00:17:10,440
she started planting a garden and

409
00:17:14,320 --> 00:17:12,450
watering it and this business about

410
00:17:17,860 --> 00:17:14,330
doing chores around the house is

411
00:17:20,870 --> 00:17:17,870
interesting in the fact that without

412
00:17:23,720 --> 00:17:20,880
without prompting and without being led

413
00:17:26,210 --> 00:17:23,730
to do them she didn't do them before now

414
00:17:28,010 --> 00:17:26,220
she does them spontaneously the father

415
00:17:30,170 --> 00:17:28,020
called me and said you know what's

416
00:17:32,090 --> 00:17:30,180
really fun to see is for the first time

417
00:17:36,160 --> 00:17:32,100
ever she put soap in the dishwashing

418
00:17:39,620 --> 00:17:36,170
machine she couldn't do that before so

419
00:17:42,980 --> 00:17:39,630
conclusion it looks like to us that SLO

420
00:17:45,200 --> 00:17:42,990
has some utility for both acute and

421
00:17:47,510 --> 00:17:45,210
chronic traumatic brain injury we think

422
00:17:49,460 --> 00:17:47,520
this has a great deal of possibilities

423
00:17:51,440 --> 00:17:49,470
again effects are seeing

424
00:17:52,909 --> 00:17:51,450
in just a matter of a few days in some

425
00:17:55,640 --> 00:17:52,919
cases like the lady falling off her

426
00:17:56,720 --> 00:17:55,650
horse and having headache other times it

427
00:17:59,990 --> 00:17:56,730
takes a little bit longer to see a

428
00:18:03,770 --> 00:18:00,000
response that third dot point is really

429
00:18:06,620 --> 00:18:03,780
important that is healing continues as

430
00:18:08,720 --> 00:18:06,630
we saw in this girl for months so it's

431
00:18:10,430 --> 00:18:08,730
not a matter everything that heals and

432
00:18:11,510 --> 00:18:10,440
that's the end of it healing can go on

433
00:18:13,490 --> 00:18:11,520
for a long long time

434
00:18:14,630 --> 00:18:13,500
I suspect the next report from the

435
00:18:16,430 --> 00:18:14,640
father is going to show that there's

436
00:18:18,770 --> 00:18:16,440
further improvement in his daughter and

437
00:18:22,279 --> 00:18:18,780
it doesn't matter how old the injuries

438
00:18:24,140 --> 00:18:22,289
are this is a reversible disease and

439
00:18:26,659 --> 00:18:24,150
thank goodness it's safe to prove that

440
00:18:30,230 --> 00:18:26,669
other than just anecdotally like this we

441
00:18:32,360 --> 00:18:30,240
did do some animal studies and we put my

442
00:18:35,930 --> 00:18:32,370
IV injection into rats 7 consecutive

443
00:18:37,700 --> 00:18:35,940
days SLO 5000 times more concentrated

444
00:18:40,850 --> 00:18:37,710
than what these patients are getting and

445
00:18:43,430 --> 00:18:40,860
no adverse responses so what we're going

446
00:18:46,700 --> 00:18:43,440
to do we're raising money now to conduct

447
00:18:47,930 --> 00:18:46,710
from former a formal FDA trials these

448
00:18:49,580 --> 00:18:47,940
are some of the parameters we'll measure

449
00:18:51,620 --> 00:18:49,590
and the patients and that are enrolled

450
00:18:53,570 --> 00:18:51,630
in the trial will license a product out

451
00:18:56,480 --> 00:18:53,580
to some big companies that'll screw it

452
00:18:58,700 --> 00:18:56,490
up somehow and with any luck we'll get

453
00:19:04,850 --> 00:18:58,710
it out to the people that need it and

454
00:19:14,870 --> 00:19:04,860
that's the end of that so if there any

455
00:19:21,620 --> 00:19:18,409
a bit of a clarification please do you

456
00:19:23,690 --> 00:19:21,630
know do you know when this fellow who's

457
00:19:27,350 --> 00:19:23,700
been writing all these reports uses the

458
00:19:30,230 --> 00:19:27,360
phrase still calmer does that mean even

459
00:19:32,840 --> 00:19:30,240
calmer than last time or just continuing

460
00:19:34,520 --> 00:19:32,850
to be calmer than in there pathological

461
00:19:36,320 --> 00:19:34,530
state they reach a base which we would

462
00:19:38,899 --> 00:19:36,330
call normal it's not as if they become

463
00:19:42,770 --> 00:19:38,909
comatose unresponsive or anything of

464
00:19:47,360 --> 00:19:42,780
that sort you had some very nice control

465
00:19:50,029 --> 00:19:47,370
data in the animal model in the in the

466
00:19:52,010 --> 00:19:50,039
patients in the humans did you have any

467
00:19:54,590 --> 00:19:52,020
any control data there the placebo

468
00:19:57,289 --> 00:19:54,600
effect which is a biological effect I

469
00:20:01,100 --> 00:19:57,299
fully believe that can be huge do you

470
00:20:02,870 --> 00:20:01,110
have any patients or any cases where

471
00:20:05,150 --> 00:20:02,880
you've done this in

472
00:20:06,920 --> 00:20:05,160
old matter or have you used controls at

473
00:20:11,090 --> 00:20:06,930
all no and there are a couple of reasons

474
00:20:12,350 --> 00:20:11,100
for that the iris and our experience

475
00:20:14,720 --> 00:20:12,360
with these patients the patients are

476
00:20:16,760 --> 00:20:14,730
their own control we have not done any

477
00:20:18,860 --> 00:20:16,770
placebo work because this is not an FDA

478
00:20:20,750 --> 00:20:18,870
study we're just trying to treat

479
00:20:22,820 --> 00:20:20,760
patients and get them better in the FDA

480
00:20:25,190 --> 00:20:22,830
study that we're proposing there will be

481
00:20:26,870 --> 00:20:25,200
controls of the sort you're asking of

482
00:20:29,060 --> 00:20:26,880
yes because I think that's an important

483
00:20:32,500 --> 00:20:29,070
caution here because if the patients are

484
00:20:34,880 --> 00:20:32,510
their own control the lesea bow effect

485
00:20:37,340 --> 00:20:34,890
I'm not saying it is the placebo effect

486
00:20:38,720 --> 00:20:37,350
but we can't rule that out you can't

487
00:20:41,800 --> 00:20:38,730
rule it out it's a little unusual to

488
00:20:44,600 --> 00:20:41,810
have a placebo effect lasting 289 days

489
00:20:50,720 --> 00:20:44,610
that's a long pussy-boy effect it can

490
00:20:53,240 --> 00:20:50,730
happen not to argue not too often yes

491
00:20:55,460 --> 00:20:53,250
John are you giving one initial dosers

492
00:20:57,590 --> 00:20:55,470
their dosage ongoing they take a

493
00:20:59,030 --> 00:20:57,600
sublingual drop four times a day one

494
00:21:03,050 --> 00:20:59,040
drop under the tongue four times a day

495
00:21:04,220 --> 00:21:03,060
and have you done any imaging - no we

496
00:21:06,200 --> 00:21:04,230
haven't had the funds to do that but

497
00:21:11,090 --> 00:21:06,210
that's part of the proposed FDA try

498
00:21:14,090 --> 00:21:11,100
thank you in the streptococcus organism

499
00:21:14,810 --> 00:21:14,100
the exotoxin before it's oxidized is its

500
00:21:16,760 --> 00:21:14,820
purpose

501
00:21:20,570 --> 00:21:16,770
- that organism just to cause tissue

502
00:21:23,330 --> 00:21:20,580
damage so that it's more infectious the

503
00:21:25,490 --> 00:21:23,340
Toyotas of all the compounds in all of

504
00:21:29,150 --> 00:21:25,500
biology what made you think that that

505
00:21:31,640 --> 00:21:29,160
would have an effect on this when you

506
00:21:34,280 --> 00:21:31,650
have thought the same haha not at the

507
00:21:40,160 --> 00:21:34,290
time I had no I wouldn't know what else

508
00:21:47,240 --> 00:21:40,170
to use it's true strictly by accident

509
00:21:50,360 --> 00:21:47,250
okay i I don't mean to to be coy about

510
00:21:53,360 --> 00:21:50,370
that if we got we have two minutes and I

511
00:21:54,800 --> 00:21:53,370
can explain it very quickly there was a

512
00:21:57,350 --> 00:21:54,810
study done at Brown University Medical

513
00:22:01,060 --> 00:21:57,360
School a few years ago that showed that

514
00:22:04,730 --> 00:22:01,070
patients that have movement disorders

515
00:22:08,360 --> 00:22:04,740
have a history of repeated or chronic

516
00:22:10,310 --> 00:22:08,370
strep infection so I thought well those

517
00:22:11,600 --> 00:22:10,320
patients must have some problem with the

518
00:22:13,730 --> 00:22:11,610
strep still in their body or maybe

519
00:22:16,280 --> 00:22:13,740
something the cross reacts my big idea

520
00:22:16,760 --> 00:22:16,290
was that why don't we use a fraction

521
00:22:18,560 --> 00:22:16,770
list

522
00:22:21,770 --> 00:22:18,570
organism and treat those movement

523
00:22:22,880 --> 00:22:21,780
disorders just for fun so I asked some

524
00:22:25,370 --> 00:22:22,890
of the physicians in our group if they

525
00:22:26,840 --> 00:22:25,380
had any such patients one had a patient

526
00:22:28,160 --> 00:22:26,850
like that that a horrible tick to the

527
00:22:29,960 --> 00:22:28,170
head like this

528
00:22:31,630 --> 00:22:29,970
it was just sat with that patient in two

529
00:22:34,460 --> 00:22:31,640
minutes you'd be going like this too and

530
00:22:36,790 --> 00:22:34,470
that patient was asked if she would be

531
00:22:39,320 --> 00:22:36,800
willing to take this product that we had

532
00:22:42,410 --> 00:22:39,330
experimentally that we thought might

533
00:22:43,940 --> 00:22:42,420
help her tick and we were confident it

534
00:22:46,790 --> 00:22:43,950
would be safe we had no idea if it would

535
00:22:49,340 --> 00:22:46,800
have any biological effect and she being

536
00:22:52,150 --> 00:22:49,350
a nice lady agreed to do it and she came

537
00:22:53,870 --> 00:22:52,160
back four weeks later and the tick was

538
00:22:56,510 --> 00:22:53,880
remarkably reduced but not eliminated

539
00:22:58,340 --> 00:22:56,520
but the attending physician said did you

540
00:22:59,750 --> 00:22:58,350
see anything else good or bad happen and

541
00:23:00,080 --> 00:22:59,760
she about punch him said yeah look at

542
00:23:04,100 --> 00:23:00,090
that

543
00:23:06,710 --> 00:23:04,110
and nice hand what about it and she said

544
00:23:08,750 --> 00:23:06,720
well she says I'm 34 years old when I

545
00:23:11,270 --> 00:23:08,760
was nine years old I pulled a sauce pan

546
00:23:13,820 --> 00:23:11,280
of boiling water off my mother's stove

547
00:23:15,700 --> 00:23:13,830
and it went over my hands and scarred my

548
00:23:18,530 --> 00:23:15,710
knuckles and the scars are all gone

549
00:23:19,730 --> 00:23:18,540
that's how we found it okay okay and I

550
00:23:22,010 --> 00:23:19,740
just want to go on record as saying

551
00:23:24,290 --> 00:23:22,020
animal models are cruel and terrible and

552
00:23:25,070 --> 00:23:24,300
hopefully the FDA will change and you

553
00:23:28,940 --> 00:23:25,080
won't have to do that

554
00:23:30,530 --> 00:23:28,950
good luck them all with you with respect

555
00:23:31,970 --> 00:23:30,540
to the to the mechanism I know you can't

556
00:23:33,350 --> 00:23:31,980
speak of this in the in the human model

557
00:23:35,690 --> 00:23:33,360
at the rat model so are you suggesting

558
00:23:37,669 --> 00:23:35,700
that the reduced inflammation is

559
00:23:39,200 --> 00:23:37,679
facilitating synapse synaptogenesis

560
00:23:41,870 --> 00:23:39,210
which is kind of helping the overall

561
00:23:45,020 --> 00:23:41,880
connectivity or no we're looking more

562
00:23:46,280 --> 00:23:45,030
that gliosis the scarring is interfering

563
00:23:49,610 --> 00:23:46,290
what normal transmission of messages

564
00:23:51,740 --> 00:23:49,620
from cell to cell that's it and same

565
00:23:53,690 --> 00:23:51,750
thing with the chronic situation so if

566
00:23:55,880 --> 00:23:53,700
we can either prevent that tissue from

567
00:23:57,860 --> 00:23:55,890
the scar interfering material from

568
00:23:59,720 --> 00:23:57,870
forming or eliminate that which is

569
00:24:01,910 --> 00:23:59,730
already formed the messages can get

570
00:24:03,950 --> 00:24:01,920
through and away we go we do not think

571
00:24:06,250 --> 00:24:03,960
we're doing anything to induce neuronal

572
00:24:09,860 --> 00:24:06,260
growth or anything of that sort

573
00:24:11,990 --> 00:24:09,870
I think we're clearing that by getting

574
00:24:16,280 --> 00:24:12,000
rid of some of this damage caused by the

575
00:24:18,410 --> 00:24:16,290
inflammation yep I'm excited about this

576
00:24:21,910 --> 00:24:18,420
because my cousin's daughter just got

577
00:24:25,430 --> 00:24:21,920
involved in one of those accidents and

578
00:24:26,900 --> 00:24:25,440
but as a massage therapist I noticed I

579
00:24:29,360 --> 00:24:26,910
work with a lot of people with the

580
00:24:30,380 --> 00:24:29,370
chronic TBI and the back of the head and

581
00:24:33,530 --> 00:24:30,390
the muscles here in the

582
00:24:35,570 --> 00:24:33,540
collagen and is all seems to be part of

583
00:24:37,520 --> 00:24:35,580
it and constricting on the cranial

584
00:24:39,290 --> 00:24:37,530
nerves just because of the muscle thing

585
00:24:43,250 --> 00:24:39,300
and have you looked at that in terms of

586
00:24:45,230 --> 00:24:43,260
that you know we haven't but since we

587
00:24:47,480 --> 00:24:45,240
know that the SLO works on those kinds

588
00:24:49,040 --> 00:24:47,490
of scars also that might very well be a

589
00:24:51,080 --> 00:24:49,050
component to the recovery we're seeing

590
00:24:54,130 --> 00:24:51,090
and I look forward to the micro glial

591
00:24:57,350 --> 00:24:54,140
aspect to that seems very important I

592
00:24:58,880 --> 00:24:57,360
have several questions number one but

593
00:25:02,300 --> 00:24:58,890
first I want to state I think it's great

594
00:25:04,010 --> 00:25:02,310
you're working on this and because I

595
00:25:07,370 --> 00:25:04,020
have a friend who lost his son to

596
00:25:08,210 --> 00:25:07,380
suicide because of this are you going to

597
00:25:10,280 --> 00:25:08,220
do I understand you're going to do

598
00:25:13,400 --> 00:25:10,290
imaging are you gonna do QE II G's as

599
00:25:15,980 --> 00:25:13,410
well whatever we have funds for okay

600
00:25:18,500 --> 00:25:15,990
there's a lot to be done and is there an

601
00:25:21,440 --> 00:25:18,510
age limit to how young you will give

602
00:25:23,630 --> 00:25:21,450
this to somebody well there might be the

603
00:25:25,910 --> 00:25:23,640
youngest we've ever given is about six

604
00:25:29,990 --> 00:25:25,920
weeks of age and that was without any

605
00:25:31,610 --> 00:25:30,000
problem okay thank you I must have

606
00:25:34,280 --> 00:25:31,620
missed this did is this an ongoing

607
00:25:37,130 --> 00:25:34,290
treatment like for 200 days or well

608
00:25:39,980 --> 00:25:37,140
there's no no set limit until the person

609
00:25:42,560 --> 00:25:39,990
plateaus and gets tired of taking drops

610
00:25:43,880 --> 00:25:42,570
they keep taking them so it once healing

611
00:25:47,500 --> 00:25:43,890
is occurred there's no reason to think

612
00:25:49,700 --> 00:25:47,510
they're going to relapse with scars but

613
00:25:53,150 --> 00:25:49,710
the clinical trial will be a 90 day

614
00:25:55,730 --> 00:25:53,160
trial but just one patient as you can

615
00:25:56,870 --> 00:25:55,740
see is going close to a year now and we

616
00:25:58,010 --> 00:25:56,880
have other patients that have gone as

617
00:25:59,690 --> 00:25:58,020
many as four years some of the old

618
00:26:02,570 --> 00:25:59,700
football continuing the same treatment

619
00:26:05,210 --> 00:26:02,580
yep okay yeah although usually after a

620
00:26:06,500 --> 00:26:05,220
few months they don't hit four times a

621
00:26:07,760 --> 00:26:06,510
day they might get one in the morning

622
00:26:10,610 --> 00:26:07,770
and one in the evening something like

623
00:26:12,590 --> 00:26:10,620
that right on time

624
00:26:13,300 --> 00:26:12,600
thank you very much big round of