Autologous Bone Marrow-Derived Cell Therapy Combined with Physical Therapy Induces Functional Improvement in Chronic Spinal Cord Injury Patients

El-Kheir, Wael Abo; Gabr, Hala; Awad, Mahrous; Ghannam, Osama; Barakat, Yousef Abdel El Gelel; Farghali, Haithem A.; Maadawi, Zeinab M. El; Ewes, Ibrahim; Sabaawy, Hatem E.

doi:10.3727/096368913x664540

Cited by 118 publications

(88 citation statements)

References 36 publications

(48 reference statements)

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“…Stem cell therapy is beneficial for SCI repair (39), and the multiple beneficial mechanisms by which ABMC therapy repairs injuries suggest that ABMC transplantation achieves an initial preclinical efficacy (23) in a large mammalian SCI model. These data are in accordance with the beneficial effects seen with ABMC transplantation in human SCI patients based on the initial outcome data of our phase I/II clinical trial (13). Intrathecal transplantation of autologous ABMCs in the canine SCI model was associated with remyelination and functional improvement.…”

Section: Discussionsupporting

confidence: 89%

“…Indeed, autologous cell therapy for SCI remains to date a more safe and feasible strategy. BM cells with limited culture expansion have been used in pilot studies and human clinical trials to improve neurological functions when delivered near the injury site via intra-arterial (40) and intrathecal injections (13,22) in chronic SCI patients. Importantly, all human trials demonstrate the superior safety profile of BM-derived cells (8,42).…”

Section: Discussionmentioning

confidence: 99%

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Intrathecal Transplantation of Autologous Adherent Bone Marrow Cells Induces Functional Neurological Recovery in a Canine Model of Spinal Cord Injury

et al. 2015

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Spinal cord injury (SCI) results in demyelination of surviving axons, loss of oligodendrocytes, and impairment of motor and sensory functions. We have developed a clinical strategy of cell therapy for SCI through the use of autologous bone marrow cells for transplantation to augment remyelination and enhance neurological repair. In a preclinical large mammalian model of SCI, experimental dogs were subjected to a clipping contusion of the spinal cord. Two weeks after the injury, GFP-labeled autologous minimally manipulated adherent bone marrow cells (ABMCs) were transplanted intrathecally to investigate the safety and efficacy of autologous ABMC therapy. The effects of ABMC transplantation in dogs with SCI were determined using functional neurological scoring, and the integration of ABMCs into the injured cords was determined using histopathological and immunohistochemical investigations and electron microscopic analyses of sections from control and transplanted spinal cords. Our data demonstrate the presence of GFP-labeled cells in the injured spinal cord for up to 16 weeks after transplantation in the subacute SCI stage. GFP-labeled cells homed to the site of injury and were detected around white matter tracts and surviving axons. ABMC therapy in the canine SCI model enhanced remyelination and augmented neural regeneration, resulting in improved neurological functions. Therefore, autologous ABMC therapy appears to be a safe and promising therapy for spinal cord injuries.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Intrathecal Transplantation of Autologous Adherent Bone Marrow Cells Induces Functional Neurological Recovery in a Canine Model of Spinal Cord Injury

et al. 2015

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“…Awareness of potential problems related to small sample size, yet without referring to the choice of a particular statistical method, was present in 92 studies (55%). Different implications thereof were mentioned, ranging from considerable baseline variability, which could not be accounted for, to limited generalizability of the results, decreased power, and the need for replication in larger samples . Seventeen studies (10%) stated a rule‐of‐thumb like justification for the choice of a particular statistical approach, mainly that nonparametric methods were used instead of parametric approaches due to the small sample size .…”

Section: Resultsmentioning

confidence: 99%

Sample sizes and statistical methods in interventional studies on individuals with spinal cord injury: A systematic review

Zimmermann

Bolter

Sluka

et al. 2019

J Evidence Based Medicine

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Aim Prevalence and incidence of spinal cord injury (SCI) are low. However, sample sizes have not been systematically examined yet, although this might represent useful information for study planning and power considerations. Therefore, our objective was to determine the median sample size in clinical trials on SCI individuals. Moreover, within small‐sample size studies, statistical methods and awareness of potential problems regarding small samples were examined. Methods We systematically reviewed all studies on human SCI individuals published between 2014 and 2015, where the effect of an intervention on one or more health‐related outcomes was assessed by means of a hypothesis test. If at least one group had a size <20, the study was classified as a small sample size study. PubMed was searched for eligible studies; subsequently, data on sample sizes and statistical methods were extracted and summarized descriptively. Results Out of 8897 studies 207 were included. Median total sample size was 18 (range 4‐582). Small sample sizes were found in 167/207 (81%) studies, resulting limitations and implications for statistical analyses were mentioned in 109/167 (65%) studies. Conclusions Although most recent SCI trials have been conducted with small samples, the consequences on statistical analysis methods and the validity of the results are rarely acknowledged.

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“…The intrathecal route of administration was chosen because of the simplicity, safety, and proven efficacy in other cerebral trials (29). Doeppner and Hermann (2014) performed critical review of the clinical trials conducted using stem cell therpy for ischemic stroke (24).…”

Section: Discussionmentioning

confidence: 99%

Intrathecal Autologous Bone Marrow Derived Mesenchymal Stem Cells for Ischemic Stroke: Short Term Safety and Efficacy Study

W¹

2015

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Abstract:Background: Preclinical and animal studies provide considerable hope for stem cell therapy in cerebrovascular stroke. This study was designed as a pilot study to explore this provisional data. Autologous bone marrow derived mesenchymal stem cells were chosen due to their proven angiogenic, paracrine and neuroregenerative functions. Subjects and Methods: The present study included 32 patients with ischemic stroke fulfilling the following criteria: Inclusion Criteria: 1. Patients with established stroke in the distribution of the middle cerebral artery territory. 2. Six months at least after the onset of acute ischemic stroke. 3. CT brain at the onset denoting acute ischemic stroke. Exclusion Criteria: 1. Hemorrhagic stroke. 2. Conditions which mimick stroke,e.g., multiple sclerosis, vasculitis, arteriovenous malformations, trauma, tumours. Patients were randomly divided into control group (11 patients) and study group (21 patients) which was further divided according to the time between the onset of the stroke and the beginning of the study into: Group I : onset of the stroke and the beginning of the study :6-12 months( 12 patients: 6 males and 6 females). Group II: onset of stroke and the beginning of the study :13-36 months (9 patients: 5 males and 4 females). Control Group: 11 stroke patients : 6 males and 5 females. Time from onset of stroke to beginning of the study ranged from 6-30 months. Both study and control group were subjected to thorough clinical and laboratory assessment , CT brain, National institutes of Health Stroke Scale (NIHSS) and th Barthel active daily life (ADL) scale at the start of therapy, and at 1,3,6 and 12 months after the start of therapy. Stem Cell Injection: 10 million autologous bone marrow-derived MSCs were injected via lumbar puncture in the study group. Results and Conclusions: Changes in Follow-up Parameters: 1. Changes in NIHSS score: Control group showed non-significant decrease in NIHSS score starting from the 3 rd month. On the other hand, study group showed highly significant decrease in NIHSS score starting from 6 th month, more in group I. 2. Changes in ADL score: ADL score showed non-significant increase starting from 3 rd month in the control group, while it showed a highly significant increase in the study group starting from 6 th month, more pronounced in group I. Intrathecal administration of MSCs is safe and enhances regeneration in ischemic stroke patients.

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Autologous Bone Marrow-Derived Cell Therapy Combined with Physical Therapy Induces Functional Improvement in Chronic Spinal Cord Injury Patients

Cited by 118 publications

References 36 publications

Intrathecal Transplantation of Autologous Adherent Bone Marrow Cells Induces Functional Neurological Recovery in a Canine Model of Spinal Cord Injury

Intrathecal Transplantation of Autologous Adherent Bone Marrow Cells Induces Functional Neurological Recovery in a Canine Model of Spinal Cord Injury

Sample sizes and statistical methods in interventional studies on individuals with spinal cord injury: A systematic review

Intrathecal Autologous Bone Marrow Derived Mesenchymal Stem Cells for Ischemic Stroke: Short Term Safety and Efficacy Study

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