Innovations In Clinical Neuroscience

MAR-APR 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 4 , N U M B E R 3 – 4 , M A R C H – A P R I L 2 0 1 7 ] 13 antibodies, infection in maternal blood, exposure to heavy metals, prenatal folic acid deficiency, genetic disorders, measles, and electromagnetic radiation. These factors can all have detrimental effects on the central nervous system (CNS), neurodevelopment, and environmental responsive genes. 1 There is no cure for ASD; however, a better quality of life may be achieved by improving intellectual, social, and physical deficits, increasing functional independence, and improving immunity. Stem cell therapy is showing promise in the treatment of incurable diseases. It is believed that stem cell therapy slows or blocks disease progression. 6 Human embryonic stem cells (hESC) are pluripotent, can proliferate indefinitely, and can differentiate into all cell types. 7 This provides a rationale for using hESC therapy in ASD. 8 We have shown an improvement in patients with cerebral palsy and cortical visual impairment after treatment with hESC therapy. 9 Here, we report the effects of hESC therapy on three pediatric patients with ASD. MATERIALS AND METHODS The present study evaluated the effects of hESC therapy in three patients with ASD. hESCs (NTECH-2000n/nn) are cultured and maintained as per our proprietary, patented technology in a laboratory at Nutech Mediworld (Patent- WO 2007/141657A PCT/1B 2007 Published 13 Dec 2007), which is certified with Good Manufacturing Practices (GTP), Good Laboratory Practices (GLP), and Good Tissue Practices (GTP). The study was approved by an independent institutional ethics committee (IEC) and was conducted in accordance to the principles laid down by "Declaration of Helsinki." 10 The technique of administrating hESC therapy has been described elsewhere. 9 The hESC treatment strategy was divided into phases. In the first phase, T1, 0.25ml hESCs (<4 million cells) were administered intramuscularly (i.m.) once a day to "prime" the body, 1mL hESCs (<16 million cells) were administered twice a week intravenously to "home in" on the required area, and 1- to 5mL hESCs were administered every seven days by supplemental routes (e.g., via epidural, popliteal block, brachial plexus block, intrathecal, epidural catheter caudal, deep spinal muscle) to introduce the stem cells into the central nervous system (CNS) (local action). Nasal spray was given twice a week to enhance the absorption of hESC in the brain. After a gap of 4 to 8 months, the subsequent phases—T2 (4–6 weeks) and T3 (4–6 weeks)—were administered following the same dosage regimen as T1. T2 and T3 were utilized to add more cells into the body, thus aiding in repair and regeneration to a greater extent. All patients' legal guardians provided written, informed consent prior to the treatment. The condition of the patients was videographed before, during, and after the treatment periods. Biochemical and radiological investigations were performed before the start of the treatment and then at regular intervals throughout the treatment phases. CASE SERIES Case 1. A three-year-old boy was admitted to Nutech Mediworld on 3 November 2012 with parental complaints of poor attention span, no eye contact, no social interaction, flapping of hands, inability to point at objects, lack of functional independence, mouthing, babbling, and inability to speak clearly. At the age of one and a half years, the patient's parents observed that he did not make eye contact, did not respond to his name, and did not play with others. He was diagnosed with ASD at the age of two years, and since then, he has been undergoing occupational and speech therapy. Patient history revealed that he was born by a lower (uterine) segment caesarean section (LSCS) due to being overdue for delivery (13 days) with no progress of labor. On investigation, brain single-photon emission computed tomography (SPECT) scan revealed moderate to severe hypoperfusion in bilateral (B/L) frontal and B/L temporal regions. Moderate hypoperfusion was observed in B/L parietal regions and in B/L cerebellar regions. The patient was treated with hESCs as the primary therapy, along with occupational and physical therapy, for eight weeks starting from 3 November, 2012 to 29 December, 2012. Following the first session of hESC therapy, the patient showed improvements in eye contact, social behaviors, and speaking, and was able to follow basic commands, such as "throw the ball" and "hold the ball." Mouthing and hand flapping also decreased. After a gap of four months, the patient returned for the second treatment session. Since his last follow-up visit, his parents reported that he was exhibiting attention- seeking behavior, rocking his body, and throwing tantrums. He followed less commands and had shorter span of eye contact. Following the second treatment session, the patient showed improvement in eye contact, vocabulary, and social awareness. He was playful and became emotionally attached to his parents. The patient also showed improvement in functional independence (e.g., he started wearing sandals on his own). The brain SPECT scan following the second session showed minimal hypoperfusion in left cerebellar region. Significant improvement in perfusion was seen in the cerebral and cerebellar regions. Figure 1 represents SPECT scan images of the patient before and after the second session of therapy. The patient was brought in for the third session of hESC therapy on 28 October, 2013. Following the treatment, improvement was seen in his expressions and attention span, and tantrums and mouthing were significantly reduced, though still present. Overall, following the three therapy sessions, the patient showed improvement in eye contact and attention span and significant reduction in mouthing. He was able to follow instructions, he showed improvement in functional independence, was playful, and exhibited improved social awareness and emotional attachment to his parents. Case 2. A 10-year-old boy with impaired speech, uncoordinated talk and walk, low intelligence quotient (IQ), cognitive impairment, and poor concentration was admitted to Nutech Mediworld on 20 June, 2011. The history revealed that the patient was delivered by induced labor and was forceps assisted. At the age of two years,

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