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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