For an
overview on these procedures,
click
here. The following was
abstracted from information provided in Dr. Geeta Shroff’s patent
application:
CASE
STUDY 1
The
practice of the present invention resulted in the reversal of the
symptoms of SCI in a subject suffering from SCI by transplantation of
hES cells according to the protocol described herein.
… a 29 year
old subject with a C6-C7 fracture and dislocation was declared
untreatable by different medical practices. The subject had no sensation
from the inter mammary area downwards, and was unable to sit on his own,
had no bladder or bowel control, was not able to move his arms and
fingers and had no power or tone in his legs. The subject had developed
non-healing bilateral bedsores during a period of three years.
Administration of hES cells and their derivatives according to the
practices of the present invention was initiated under these conditions
as follows.
A
pharmaceutical composition containing approximately about 750,000 to
about 80 million hES cells and their derivatives including hematopoietic
stem cell progenitors and neuronal stem cell progenitors was diluted in
sterile normal saline to a final volume of 0.25 to 1.0 ml, karyotyped,
tested for contamination, viability and count using standard protocols
and then administered by subcutaneous injection in the forearm. The
subject was observed for anaphylactic shock, pain or inflammation at the
site of the injection, generalised itching, flushing or fever after five
minutes, ten minutes, fifteen minutes, thirty minutes, one hour and
twenty four hours.
Treatment
of the subject was by administration of a subcutaneous priming injection
of a pharmaceutical composition containing 750,000 to 80 million hES
cells and their derivatives, wherein said cells comprise hematopoietic
stem cell progenitors and neuronal stem cell progenitors, resuspended in
a volume of 0.25 ml to 1.0 ml of sterile normal saline. A further
priming injection carrying the same number of hematopoietic stem cells
and neuronal stem cells resuspended in 0.25 ml to 1.0 ml of sterile
normal saline was administered by intramuscular injection. A final
priming injection of 750,000 to 80 million neuronal stem cell
progenitors resuspended in a volume of 0.25 ml to 1.0 ml of sterile
normal saline was administered by intravenous injection.
Direct
treatment of the SCI according to the practice of the present invention
was performed by resuspension of a pharmaceutical composition comprising
750,000 to 80 million hES cells and their derivatives, wherein said
cells comprise neuronal stem cell progenitors, resuspended in a volume
of 2 ml of sterile normal saline and further diluted to 15 ml to 40 ml
of sterile normal saline and administered by epidural injection at the
site, below the site, and above the site of the lesion seven days after
the first priming injection. Treatment by administration of epidural
injection was repeated after one and a half months of priming, four
months after priming, and six months after priming.
In addition
to the epidural administration, the subject was treated by intrathecal
injection of a pharmaceutical composition comprising 750,000 to 11
million hES cells and their derivatives, wherein said cells comprise
hematopoietic stem cell progenitors and neuronal stem cell progenitors
resuspended in 2 ml of sterile normal saline two and five months after
the start of the treatment.
In
addition, the subject was treated with an epidural injection of a
pharmaceutical composition comprising 750,000 to 80 million hES cells
and their derivatives, wherein said cells comprise neuronal stem cell
progenitors, resuspended in 2 ml of sterile normal saline and further
diluted to a final volume of 4 ml, twice daily for three consecutive
days.
The
neurological well-being of the subject was evaluated at regular
intervals after the start of treatment, and a marked improvement of the
mental state and general hygiene of the subject was observed after two
weeks as shown in...
Signs and
symptoms typical of damage to the autonomous nervous system as a result
of a C6-C7 fracture were evaluated during the course of the treatment. A
marked and progressive improvement in all parameters tested, including
the ability to sense deep pressure, sense of touch, sensation, balance,
ability to sense pain, ability to sense change in temperature,
involuntary movements, presence of cold sweats, giddiness, blood
pressure, breathing difficulty, abnormal posture whilst lying down and
ability to sit unaided, was observed as shown in …
Bladder and
bowel dysfunction is commonly associated with neurological damage as a
result of SCI. This damage results in impaired bladder control, bladder
stream and sensation of fullness in the bladder, bowel control, time for
evacuation of the bowel and sensation in the bowel. During the course of
the treatment, marked and progressive improvements in all parameters
tested were observed as a result of the treatment as shown in…
Changes in
the motor function of the upper body, as evidence for neural
regeneration at the site of the C6-C7 lesion were evaluated during the
course of the treatment. Marked and progressive improvements in shoulder
movement, wrist and finger movement, power in the fingers., tendon
reflexes, strength of limb movement, muscular atrophy and hand grasp
were observed as shown in…
Changes in
the motor function of the lower body, as evidence for neural
regeneration at the site of the C6-C7 lesion, were evaluated during the
course of the treatment, including hip movement, knee movement, toe
movement, tendon reflexes, strength of the limb, muscular atrophy and
plantar response. Although there was no improvement in any of the
parameters tested during the course of the study, after three months of
treatment, the subject was able to stand with the aid of a walking frame
as shown in…
CASE
STUDY 2
… a twenty
two year old subject suffered with post traumatic paraplegia SCI as a
result of a D6-D7 fracture after a fall from a second floor roof top.
The subject went into a coma for two days after the fall and regained
consciousness, but developed bilateral paralysis with total sensory and
motor loss of the lower half of the body from the inter mammary region
to the feet, and was unable to lift his feet or legs and was unable to
sit unaided or get up into a sitting position. The subject was
permanently bed ridden, had lost bladder and bowel control and was
totally dependent upon the support of his family although his upper
limbs were unaffected.
Administration of a pharmaceutical composition comprising hES cells and
their derivatives according to the practice of the present invention was
initiated after five months of the injury. In five months time, the
subject regained bladder and bowel control, and ability to sit without
support, and slide up and down by lifting the hip. Sensory perception
restored to the perineal level. The subject can lift himself into a
walking frame unaided, and can stand with ease in the frame without the
need for knee support. The treatment resulted in the ability of the
subject to walk using the walking frame with the support of a knee brace
and return to work, i.e., he has regained a regular life style.
CASE
STUDY 3
…a
forty-year-old subject suffered from quadriplegic SCI as a result of a
C5-C6 injury and stiffness and pain in the neck. The subject underwent
surgery after six months and was quadriplegic since then. The subject
suffered from a feeling of sinking and dizziness if made to sit with
support, and had sensation from the upper border of the scapula upwards,
with total loss of power in all four limbs and loss of bowel and bladder
function immediately after surgery.
Administration of a pharmaceutical composition comprising hES cells and
their derivatives according to the practice of the present invention was
initiated nine months after surgery. As a result of the hES cell
treatment, the subject is able to sit comfortably without the need for
support, and is able to move and bend to the side whilst sitting in a
chair with his legs hanging down comfortably. The subject regained a
marked improvement of his control of his upper body. The subject
received substantial improvement in his general psychological well being
through the increased mobility and independence and activities. He is
able to stand with support with strength in lower limbs, control of toe
movement, and no wrist drop. Treatment is ongoing according to the
improvements of the subject's condition.
CASE
STUDY 4
… a thirty
seven year old subject who suffered spinal injury with brain damage
seventeen years ago after a road traffic accident and was confined to a
wheelchair. Subject also suffered with right-sided hemiplegia, inability
to talk, facial paralysis, a total loss of memory and no bladder
control.
The subject
was administered pharmaceutical composition comprising hES cells and
their derivatives according to the practice of the present invention for
one year and two months which resulted in the ability to walk with the
aid of a walking frame, speaking of a few words, straightened neck,
removal of facial paralysis and improving of memory.
CASE
STUDY 5
…a fifty
six year old subject who suffered from post-traumatic fracture at C5-C8
with retrovulsion of the fractured vertebrae causing cord contusion and
associated anterior epidural hemorrhage and was paraplegic. The subject
was unable to move both lower limbs and suffered acute pain in his back.
The
administration of a pharmaceutical composition comprising hES cells and
their derivatives according to the practice of the present invention was
carried out for a period of one year which resulted in regaining of some
strength in both legs, sensory perception such as vibration in the legs,
and ability to stand with the aid of a walker without back pain. The
subject can walk with the aid of a walking frame, regained bladder
control and sensation, and overcame bouts of cold sweats and giddiness.
The schedule of injections for this patient is shown in…
CASE
STUDY 6
…a twenty
five year old subject who was diagnosed with Potts Spine disorder at the
D6 level with lower limb paraplegia, underwent surgery three times with
an anterior decompression of the spinal cord. The subject was wheelchair
bound, could not sit without support, with flaccid paralysis of the
legs, had no bowel control and evacuated whilst lying and had no bladder
sensation.
The subject
was administered a pharmaceutical composition comprising hES cells and
their derivatives according to the practice of the present invention,
eleven years and six months after the injury. The treatment protocol
followed during the first year resulted in strengthening the back,
ability to sit without support, and sensation of heaviness in the legs.
The subject also regained backache during menstruation and menstrual
pain. Sensations in the thighs, legs and recovery of bladder sensation
and control were observed. The subject is able to walk with the aid of a
walking frame with good restoration of movement in both the legs.
Treatment is ongoing.
CASE
STUDY 7
…a thirty
year old subject suffering from a C6-C7 paraplegic SCI was unable to
move lower limbs and had no bowel control or bowel sensation. The
subject had fine and deep pressure sensation only from the inter mammary
region upwards. Thus, the subject had difficulty in sitting. The hands
of the subject had very little strength, with very weak finger movement
and the subject had difficulty in breathing.
The subject
was treated according to the practice of the present invention by
administration of a pharmaceutical composition comprising hES cells and
their derivatives about three months after the injury. The subject
regained ability to sit without support, suffers no giddiness, can sense
pressure in the groin, has sensation in the medial side of the elbow and
feels pain in the legs if the patient attempted to move. The subject
breathes easily, has sensation in bladder and bowel, has sensation in
legs and can now stand for a few minutes with support. The subject also
has increased strength and movement in fingers. Treatment is ongoing.
CASE
STUDY 8
…a twenty
six year old subject, paraplegic as a result of SCI at D6, was unable to
move both lower limbs, although able to sit without support. The subject
had no bladder or bowel control, and had sensation only from the inter
mammary area upwards.
The subject
was administered a pharmaceutical composition comprising hES cells and
their derivatives according to the practice of the present invention
about ten months after the injury. The subject? regained sensation in
the lateral side of the body and up to the unbilious region bilaterally
from the axillary area to the hipbone. The subject can walk with the aid
of a walking frame and a caliper with motor power in the legs.
CASE
STUDY 9
…a twenty
seven year old subject suffered with traumatic quadriplegia and had
great difficulty talking and breathing, with rigid neck. The legs of the
subject were paralysed and the subject had no finger movement and no
sensation in. the rest of the body.
The
treatment via administration of a pharmaceutical composition comprising
hES cells and their derivatives according to the practice of the present
invention was started about two years after the injury. The subject
experienced an improvement in neck movement, ease in speech, and
improvement in control of voice tone. The subject found breathing to be
less cumbersome and motor function returned with some finger movement.
The legs became less spastic and the subject was able to sit unaided.
Toe movements also resumed and the subject can move the shoulders.
CASE
STUDY 10
…a twenty
five year old subject had a road accident and lost the ability to sit
without support, the spine was prone to buckling, the subject lost
bladder and bowel control and the subject suffered a total loss of power
in the legs.
The subject
was treated by administration of a pharmaceutical composition comprising
hES cells and their derivatives according to the practice of the present
invention about two years after the injury. The subject showed rapid
improvement and can sit without support. The subject suffers no
giddiness, has movement in both feet, regained sensation in the finger
tips and can experience chill flowing through the spine.
CASE
STUDY 11
…a twenty
six year old subject with a SCI at D12-L1 as a result of a road traffic
accident was unable to stand with the knees being contracted. The
subject was able to sit without support and had normal sensations in the
limbs. The subject had no bladder or bowel control and had increased
spasticity.
The subject
was treated about twelve years after the injury by administration of a
pharmaceutical composition comprising hES cells and their derivatives
according to the practice of the present invention. The subject
experienced remarkable recovery in leg motor function with decreased
spasticity, exhibited a fully extendable right leg and a return of
strength to the left leg. The subject regained the ability to stand and
walk with the aid of calipers and a walking frame. Bladder and bowel
sensations also returned in the subject.
CASE
STUDY 12
The patient
was a 26 year old male with paraplegia after an injury between D6-D8. He
suffered a traumatic road accident in September 2004. He was totally
bedridden with no feeling below the chest, no bladder or bowel control,
and no sensation or motor power from chest downwards. He had a very deep
bed sore in the lower back in which his sacrum could be seen.
The patient
started hES cells on April 27, 2006. Because of the bedsore he could not
undergo any O/T procedures and was given daily dosages of cells
intravenously and intramuscularly, and eventually had hES cells applied
directly to his bedsore. He was also given intravenous infusions.
On his 11th
day of treatment he could stand with full calipers (waist to ankle) and
a walker and took 2 steps. As time continued his muscle power increased
and after 4 months he could take up to 100 steps and could stand for up
to 20 mins. He is able to feel his legs and move them too. He is also
able to feel bladder and bowel fullness and is able to walk now with
just a knee brace and the walker for support. His bed sore has healed
and he has resumed his studies.
CASE
STUDY 13
…The
patient is a 22 year old male who suffered a horse riding accident in
June, 2006 and is a paraplegic at T- 12, L-I. He had no power below the
waist, no bowel or bladder control, and no sensation below waist.
The patient
started treatment in September 2006 admitted for 6 weeks. He responded
to hES cells and within a week he was able to stand and walk a few steps
with full calipers (waist to ankle) and walker. He has progressed and is
on the knee brace with which he can stand for up to 30 mins with a
walker. He now has full sensation and bowel and bladder control. He also
has good balance with the stick and also the crutches. He is able to go
up and down the stairs with the caliper and the crutches.
CASE
STUDY 14
The patient
is a 26 year old female traumatic paraplegic at T- 12, L-I who suffered
a road traffic accident in September 2004. She had no feeling below the
chest and she had no bowel or bladder control. There was no motor power
in either leg and she was wheel chair bound.
The patient
started hES cells in March 2006. She was able to stand and walk a few
steps with full calipers (waist to ankle) and walker after 9 days and
continued to progress. Her current status is that she can walk
continuously with caliper and walker and also stand using the knee
brace. Bowel and bladder sensations have been restored with control and
without the usage of any catheterization or suppository. Sensation has
improved to the ankle
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