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Öğe Feasibility of allogeneic mesenchymal stem cells in pediatric hypoxic-ischemic encephalopathy: phase I study(Baishideng Publishing Group Co, 2021) Kabataş, Serdar; Civelek, Erdinç; Savrunlu, Eyüp Can; Kaplan, Necati; Boyalı, Osman; Diren, Furkan; Can, Halil; Genç, Ali; Akkoç, Tunç; Karaöz, ErdalBackground Hypoxic-ischemic encephalopathy (HIE) is one of the leading causes of death and long-term neurological impairment in the pediatric population. Despite a limited number of treatments to cure HIE, stem cell therapies appear to be a potential treatment option for brain injury resulting from HIE. Aim To investigate the efficacy and safety of stem cell-based therapies in pediatric patients with HIE. METHODS The study inclusion criteria were determined as the presence of substantial deficit and disability caused by HIE. Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) were intrathecally (IT), intramuscularly (IM), and intravenously administered to participants at a dose of 1 × 106/kg for each administration route twice monthly for 2 mo. In different follow-up durations, the effect of WJ-MSCs administration on HIE, the quality of life, prognosis of patients, and side effects were investigated, and patients were evaluated for neurological, cognitive functions, and spasticity using the Wee Functional Independence Measure (Wee FIM) Scale and Modified Ashworth (MA) Scale. Results For all participants (n = 6), the mean duration of exposure to hypoxia was 39.17 + 18.82 min, the mean time interval after HIE was 21.83 ± 26.60 mo, the mean baseline Wee FIM scale score was 13.5 ± 0.55, and the mean baseline MA scale score was 35 ± 9.08. Three patients developed only early complications such as low-grade fever, mild headache associated with IT injection, and muscle pain associated with IM injection, all of which were transient and disappeared within 24 h. The treatment was evaluated to be safe and effective as demonstrated by magnetic resonance imaging examinations, electroencephalographies, laboratory tests, and neurological and functional scores of patients. Patients exhibited significant improvements in all neurological functions through a 12-mo follow-up. The mean Wee FIM scale score of participants increased from 13.5 ± 0.55 to 15.17 ± 1.6 points (mean ± SD) at 1 mo (z = - 1.826, P = 0.068) and to 23.5 ± 3.39 points at 12 mo (z = -2.207, P = 0.027) post-treatment. The percentage of patients who achieved an excellent functional improvement (Wee FIM scale total score = 126) increased from 10.71% (at baseline) to 12.03% at 1 mo and to 18.65% at 12 mo posttreatment. Conclusion Both the triple-route and multiple WJ-MSC implantations were safe and effective in pediatric patients with HIE with significant neurological and functional improvements. The results of this study support conducting further randomized, placebo-controlled studies on this treatment in the pediatric population.Öğe Functional recovery after wharton's jelly-derived mesenchymal stem cell administration in a patient with traumatic brain injury: a pilot study(TURKISH NEUROSURGICAL SOC, 2020) Kabataş, Serdar; Civelek, Erdinç; Sezen, Gülseli Berivan; Kaplan, Necati; Savrunlu, Eyüp Can; Çetin, Ercan; Diren, Furkan; Karaöz, ErdalAIM: To introduce a traumatic brain injury (TBI) patient who underwent stem cell transplantation (SCT) in order to minimize the remaining injury deficiencies. MATERIAL and METHODS: This study included a 29 years old male who had TBI resulting from a vehicle accident which took place one and a half years ago. The participant received six doses of intrathecal, intramuscular, and intravenous transplantation of Wharton's jelly-derived mesenchymal stem cells (WJ-MSCs) at a goal dose of 1 x10(6) / kg respectively for each route of administration for six months. RESULTS: No important negative effects were reported. The patients' speech, cognitive, memory and fine motor skills were improved. The efficacy of treatment with SCT was assessed with cranial magnetic resonance imaging (MRI), computed tomography (CT) screening, and electroencephalography (EEG). CONCLUSION: SCT can have a promising future as a medical approach in recurrent TBI.Öğe Functional recovery after wharton’s jelly–derived mesenchymal stem cell administration in a patient with traumatic spinal cord injury: a pilot study(Gelenos, 2021) Kabataş, Serdar; Civelek, Erdinç; Savrunlu, Eyüp Can; Kaplan, Necati; Çetin, Ercan; Diren, Furkan; Boyali, Osman; Güven, Göksel; Karaöz, ErdalThe use of stem cells in the treatment of traumatic spinal cord injury (SCI) in recent years has provided promising results. Different sources of cells for transplantation have been used, including mesenchymal stem cells [MSCs; e.g., Wharton’s jelly-derived (MSCs WJ-MSCs)]. Here, we reported on a 29-year-old man who was treated with WJ-MSCs in the course of therapy for blunt, traumatic SCI due to a work accident. He was operated on within 6 hours of the injury. Three and a half months later, he underwent intrathecal, intramuscular, and intravenous administrations of WJ-MSCs at a target dose of 1x106/kg for each application route (twice a month for 2 months). All the procedures were tolerated well by the patient. In parallel to this, we have not seen any application-related complications so far. After stem cell infusions, progressive improvements were shown in the patient’s neurological examination and neurophysiological and neuroradiological findings.Öğe Phase I study on the safety and preliminary efficacy of allogeneic mesenchymal stem cells in hypoxic-ischemic encephalopathy(Baishideng Publishing Group Co, 2021) Kabataş, Serdar; Civelek, Erdinç; Kaplan, Necati; Savrunlu, Eyüp Can; Sezen, Gülseli Berivan; Chasan, Mourat; Can, Halil; Genç, Ali; Akyuva, Yener; Boyalı, Osman; Diren, Furkan; Karaöz, ErdalBACKGROUND Hypoxic-ischemic encephalopathy (HIE) is a leading cause of morbidity and mortality in the adult as well as in the neonate, with limited options for treatment and significant dysfunctionality. AIM To investigate the safety and preliminary efficacy of allogeneic mesenchymal stem cells (MSCs) in HIE patients. METHODS Patients who had HIE for at least 6 mo along with significant dysfunction and disability were included. All patients were given Wharton's jelly-derived MSCs at 1 × 106/kg intrathecally, intravenously, and intramuscularly twice a month for two months. The therapeutic effects and prognostic implications of MSCs were evaluated by multiple follow-ups. Functional independence measure (FIM), modified Ashworth, and Karnofsky scales were used to assess any side effects, neurological and cognitive functions, and overall outcomes. RESULTS The 8 subjects included in the study had a mean age of 33.25 ± 10.18 years. Mean HIE exposure and mean post-HIE durations were 45.63 ± 10.18 and 19.67 ± 29.04 mo, respectively. Mean FIM score was 18.38 ± 1.06, mean modified Ashworth score was 43.5 ± 4.63, and mean Karnofsky score was 20. For the first 24 h, 5 of the patients experienced a subfebrile state, accompanied by mild headaches due to intrathecally administration and muscle pain because of intramuscularly administration. Neurological and functional examinations, laboratory tests, electroencephalography, and magnetic resonance imaging were performed to assess safety of treatment. Mean FIM score increased by 20.88 ± 3.31 in the first month (P = 0.027) and by 31.38 ± 14.69 in 12 mo (P = 0.012). The rate of patients with an FIM score of 126 increased from 14.58% to 16.57% in the first month and 24.90% in 12 mo. CONCLUSION Multiple triple-route Wharton's jelly-derived MSC administrations were found to be safe for HIE patients, indicating neurological and functional improvement. Based on the findings obtained here, further randomized and placebo research could be performed.Öğe Safety and efficiency of Wharton's Jelly-derived mesenchymal stem cell administration in patients with traumatic brain injury: First results of a phase I study(Baishideng publishing group, 2024) Kabataş, Serdar; Civelek, Erdinç; Boyalı, Osman; Sezen, Gülseli Berivan; Özdemir, Ömer; Bahar-Özdemir, Yeliz; Kaplan, Necati; Savrunlu, Eyüp Can; Karaöz, ErdalBACKGROUND Traumatic brain injury (TBI) is characterized by a disruption in the normal function of the brain due to an injury following a trauma, which can potentially cause severe physical, cognitive, and emotional impairment. Stem cell transplantation has evolved as a novel treatment modality in the management of TBI, as it has the potential to arrest the degeneration and promote regeneration of new cells in the brain. Wharton's Jelly-derived mesenchymal stem cells (WJ-MSCs) have recently shown beneficial effects in the functional recovery of neurological deficits. AIM To evaluate the safety and efficiency of MSC therapy in TBI. METHODS We present 6 patients, 4 male and 2 female aged between 21 and 27 years who suffered a TBI. These 6 patients underwent 6 doses of intrathecal, intramuscular (i.m.) and intravenous transplantation of WJ-MSCs at a target dose of 1 x 10(6)/kg for each application route. Spasticity was assessed using the Modified Ashworth scale (MAS), motor function according to the Medical Research Council Muscle Strength Scale, quality of life was assessed by the Functional Independence Measure (FIM) scale and Karnofsky Performance Status scale. RESULTS Our patients showed only early, transient complications, such as subfebrile fever, mild headache, and muscle pain due to i.m. injection, which resolved within 24 h. During the one year follow-up, no other safety issues or adverse events were reported. These 6 patients showed improvements in their cognitive abilities, muscle spasticity, muscle strength, performance scores and fine motor skills when compared before and after the intervention. MAS values, which we used to assess spasticity, were observed to statistically significantly decrease for both left and right sides (P < 0.001). The FIM scale includes both motor scores (P < 0.05) and cognitive scores (P < 0.001) and showed a significant increase in pretest posttest analyses. The difference observed in the participants' Karnofsky Performance Scale values pre and post the intervention was statistically significant (P < 0.001). CONCLUSION This study showed that cell transplantation has a safe, effective and promising future in the management of TBI.Öğe Wharton's jelly-derived mesenchymal stem cell transplantation in a patient with hypoxic-ischemic encephalopathy: a pilot study(Sage Publications Inc, 2018) Kabataş, Serdar; Civelek, Erdinç; İnci, Çiğdem; Yalçınkaya, Ebru Yılmaz; Günel, Gülşen; Kır, Gülay; Albayrak, Esra; Öztürk, Erek; Adaş, Gökhan; Karaöz, ErdalWharton's jelly-derived mesenchymal stem cells (WJ-MSCs) have been introduced as a possible therapy in hypoxic-ischemic encephalopathy (HIE). We report a 16-year-old boy who was treated with WJ-MSCs in the course of HIE due to post-cardiopulmonary resuscitation. He received a long period of mechanical ventilation and tracheostomy with spastic quadriparesis. He underwent the intrathecal (1x10(6)/kg in 3 mL), intramuscular (1x10(6)/kg in 20 mL) and intravenous (1x10(6)/kg in 30 mL) administrations of WJ-MSCs for each application route (twice a month for 2 months). After stem cell infusions, progressive improvements were shown in his neurological examination, neuroradiological, and neurophysiological findings. To our best knowledge, this is a pioneer project to clinically study the neural repair effect of WJ-MSCs in a patient with HIE.
