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Case Reports From Medistem
Given the rationale that autologous SVF cells have a reasonable safety profile,
and contain both immune modulatory and regenerative cell populations, a
physician-initiated compassionate-use treatment was explored in 3 patients. Here
we describe their treatments and histories.
#CR-231
In 2005, a 50-year-old man was diagnosed with Relapsing-remitting MS,
presenting with tonic spasms, stiffness, gait imbalance, excessive hearing loss,
loss of coordination, numbness in both feet, sexual dysfunction, severe pain all
over his body, fatigue and depression. In 2005, the patient experienced refractory
spells of tonic flexion spasms, occurring for several minutes at a time and
multiple times throughout the day. He was treated with muscle relaxants, I.V.
steroids and Tegretol, and his condition had improved. However, in 2006 he
experienced severe uncontrollable tonic extensions of all four extremities lasting
about two minutes and associated with significant pain. Cranial MRI done at that
time revealed at least 30 periventricular white matter lesions. Patient also
reported excellent response to Solu-Medrol infusions. Therefore, the combination
of response to steroids, characteristic MRI abnormalities and positive oligoclonal
banding strongly suggested a diagnosis of Relapsing Remitting MS. Infusions of
Tysabri (Natalizumab, Biogen Idec) every four weeks were prescribed in
November 2006, with excellent results and no significant side effects. However,
in March 2007 patient reported spasticity approximately three weeks after the
infusions, leading to alteration of his Tysabri infusion regimen to Q3 weeks. By
June 2007 the patient had began complaining of significant memory loss and by
September 2007 he has had recurrence of his tonic spasms with multiple attacks
daily. He was treated with Solu-Medrol, Baclofen, Provigil, Tegretol, Trileptal,
Tysabri, Vitamins, Omega-3 and Zanaflex with some improvement of his
neurologic symptoms. However, he complained of severe abdominal pain,
decreased appetite and melanotic stools, consistent with stress ulcer secondary
to steroid treatment. By November 2007 the patient was still somewhat
responsive to Tysabri and I.V. Solu-Medrol, but continued to experience multiple
severe tonic spasms at a rate of 30 – 40 spasms per month.
In May 2008, the patient was treated with two I.V. infusions of 28 million SVF
cells and multiple intrathecal and intravenous infusions of allogeneic CD34+ and
MSC
cells. MSC were third party unmatched and CD34 were matched by mixed
lymphocyte reaction. Infusions were performed within a 9-day period and were
very well tolerated without any adverse or side effects. No other treatments were
necessary during the patient’s stay. After the second stem cell infusion the
patient reported a significant decrease of his generalized pain. However, he
continued to experience severe neck and shoulder pain and was re-evaluated by
his neurologist. Two months after the stem cell therapy, the volume of his hearing
aids had to be lowered once per week over 4 weeks. Three months after the
stem cell infusions the patient reported a significant improvement of his cognition
and almost complete reduction of the spasticity in his extremities. He mentioned
that he has had 623 tonic seizures in the past and confirmed that he has not
experienced any more seizures since the completion of the stem cell therapy. A
neurological evaluation performed three months after the stem cell infusions
revealed an intact cranial nerve (II-XII) function and no nystagmus, normal motor
function without any atrophy or fasciculations, and intact sensory and cerebellar
functions and mental status. New MRI images, obtained 6 months after the stem
cell treatment showed lesions, very similar to the lesions observed before the
stem cell treatment (Figure 1). The patient also reported significantly improved
memory, sexual function, and energy level. Currently, the patient is taking only
multivitamin, minerals and Omega 3.
#233
Second patient: A 32-year-old man was diagnosed in 2001 with relapsing-
remitting MS, presenting with fatigue and depression, uneven walk pattern,
cognitive dysfunction, and a progressive decline in his memory without any
specific neurological symptoms. In 2002 he was started on weekly intramuscular
Avonex (IFN-b1a, Biogen Idec) and has had no further exacerbations and no
evidence of progressive deterioration. Patient’s fatigue was treated well with
Provigil, and his mood improved significantly due to treatment with Wellbutrin SR.
In 2007, the patient complained of some mood changes, with more agitation,
irritability, mood destabilization, and cognitive slowing. As depression was
suspected in playing a central role in patient’s condition, Razadyne was added to
the antidepressant regimen.
In 2008, the patient was treated with two I.V. infusions of 25 million autologous
adipose-derived SVF cells and multiple intrathecal and intravenous infusions of
allogeneic CD34+ and MSC cells. MSC were third party unmatched and CD34
were matched by mixed lymphocyte reaction. All infusions were performed within
a 10-day period and were very well tolerated without any significant side effects.
The treatment plan also included physical therapy sessions.
Three months after the stem cell infusions the patient reported a significant
improvement of his balance and coordination as well as an improved energy level
and mood. New MRI images, obtained 7 months after the stem cell treatment
showed lesions, very similar to the lesions observed before the stem cell
treatment (Figure 2). Currently, he is not taking any antidepressants and is
reporting a significantly improved overall condition. His current treatment
regiment includes a weekly injection of Avonex, vitamins, minerals and Omega 3.
#255
The patient was diagnosed with relapsing-remitting MS in 1993, presenting
symptoms were noticeable tingling and burning sensation in the right leg,
followed by paraplegia lasting almost three weeks. Neurological investigations at
the time uncovered MRI findings suggestive for a demyelinating syndrome. In
June of 2008, the patient was treated with two I.V. infusions of 75 million
autologous adipose-derived SVF cells and multiple intrathecal and intravenous
infusions of allogeneic CD34+ and MSC cells. MSC were third party unmatched
and CD34 were matched by mixed lymphocyte reaction. All infusions were
performed within a 10-day period and were very well tolerated without any
significant side effects. His gait, balance and coordination improved dramatically
oven a period of several weeks. His condition continued to improve over the next
few months and he is currently reporting a still continuing improvement and ability
to jog, run and bike for extended periods of time daily.
Conclusion
The patients treated were part of a compassionate-use evaluation of stem cell
therapeutic protocols in a physician-initiated manner. Previous experiences in MS
patients using allogeneic CD34+ cord blood cells together with MSC did not
routinely result in substantial improvements observed in the three cases
described above. While obviously no conclusions in terms of therapeutic efficacy
can be drawn from the above reports, we believe that further clinical evaluation of
autologous SVF cells is warranted in autoimmune conditions.

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