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Chen L.,Center for Neurorestoratology | Chen L.,Beijing Hongtianji Neuroscience Academy | Huang H.,Center for Neurorestoratology | Huang H.,Beijing Hongtianji Neuroscience Academy | And 14 more authors.
Cell Transplantation | Year: 2010

Successful repair of damage in cerebral palsy (CP) needs effective clinical interventions other than simply symptomatic treatments. To elucidate the feasibility of using olfactory ensheathing cells (OECs) to treat CP in children and adolescents, we conducted a randomized controlled clinical trial (RCT) on 33 patients. The patients were randomly assigned into two groups (treatment group, n = 18; control group, n = 15), and OECs derived from aborted fetal tissue were injected into the bilateral corona radiata in the frontal lobes (a key point for neural network restoration, KPNNR). The Gross Motor Function Measure (GMFM-66) and the Caregiver Questionnaire Scale were used to evaluate the patients' neurological function and overall health status. Among the 14 patients who completed the 6-month study, six received the cell transplantation and the other eight served as controls. In OEC treatment group, GMFM-66 scores were 26.67 ± 25.33 compared with 19.00 ± 20.00 for the control group. Concurrently, the Caregiver Questionnaire Scale score decreased to 77.83 ± 15.99 in the treatment group in comparison to 138.66 ± 64.06 of the control group. This trial, albeit small in sample size, indicates OEC KPNNR transplantation is effective for functional improvement in children and adolescents with CP, yet without obvious side effects. This small-scale study suggests that the procedure may be a plausible alternative method to treat this not yet curable disorder, and we urge further evaluation with a large-scale RCT. Copyright © 2010 Cognizant Comm. Corp.


Chen L.,Center for Neurorestoratology | Chen L.,Beijing Hongtianji Neuroscience Academy | Chen D.,Beijing Hongtianji Neuroscience Academy | Xi H.,Center for Neurorestoratology | And 14 more authors.
Cell Transplantation | Year: 2012

Our previous series of studies have proven that olfactory ensheathing cell (OEC) transplantation appears to be able to slow the rate of clinical progression after OEC transplantation in the first 4 months and cell intracranial (key points for neural network restoration, KPNNR) and/or intraspinal (impaired segments) implants provide benefit for patients (including both the bulbar onset and limb onset subtypes) with amyotrophic lateral sclerosis (ALS). Here we report the results of cell therapy in patients with ALS on the basis of long-term observation following multiple transplants. From March of 2003 to January of 2010, 507 ALS patients received our cellular treatment. Among them, 42 patients underwent further OEC therapy by the route of KPNNR for two or more times (two times in 35 patients, three times in 5 patients, four times in 1 patient, and five times in 1 patient). The time intervals are 13.1 (6-60) months between the first therapy and the second one, 15.2 (8-24) months between the second therapy and the third one, 16 (6-26) months between the third therapy and the fourth one, and 9 months between the fourth therapy and the fifth time. All of the patients exhibited partial neurological functional recovery after each cell-based administration. Firstly, the scores of the ALS Functional Rating Scale (ALS-FRS) and ALS Norris Scale increased by 2.6 + 2.4 (0-8) and 4.9 + 5.2 (0-20) after the first treatment, 1.1 + 1.3 (0-5) and 2.3 + 2.9 (0-13) after the second treatment, 1.1 + 1.5 (0-4), and 3.4 + 6.9 (0-19) after the third treatment, 0.0 + 0.0 (0-0), and 2.5 + 3.5 (0-5) after the fourth treatment, and 1 point after the fifth cellular therapy, which were evaluated by independent neurologists. Secondly, the majority of patients have achieved improvement in electromyogram (EMG) assessments after the first, second, third, and fourth cell transplantation. After the first treatment, among the 42 patients, 36 (85.7%) patients' EMG test results improved, the remaining 6 (14.3%) patients' EMG results showed no remarkable change. After the second treatment, of the 42 patients, 30 (71.4%) patients' EMG results improved, 11 (26.2%) patients showed no remarkable change, and 1 (2.4%) patient became worse. After the third treatment, out of the 7 patients, 4 (57.1%) patients improved, while the remaining 3 (42.9%) patients showed no change. Thirdly, the patients have partially recovered their breathing ability as demonstrated by pulmonary functional tests. After the first treatment, 20 (47.6%) patients' pulmonary function ameliorated. After the second treatment, 18 (42.9%) patients' pulmonary function improved. After the third treatment, 2 (28.6%) patients recovered some pulmonary function. After the fourth and fifth treatment, patients' pulmonary function did not reveal significant change. The results show that multiple doses of cellular therapy definitely serve as a positive role in the treatment of ALS. This repeated and periodic cellbased therapy is strongly recommended for the patients, for better controlling this progressive deterioration disorder. © 2012 Cognizant Comm. Corp.


Huang H.,Center for Neurorestoratology | Huang H.,Beijing Hongtianji Neuroscience Academy | Huang H.,Tsinghua University | Xi H.,Beijing Hongtianji Neuroscience Academy | And 6 more authors.
Cell Transplantation | Year: 2012

The neurorestorative effect of the parenchymal transplantation of olfactory ensheathing cells (OECs) for cord trauma remains clinically controversial. The aim of this article is to study the long-term result of OECs for patients with complete chronic spinal cord injury (SCI). One hundred and eight patients suffered from complete chronic SCI were followed up successfully within the period of 3.47 ± 1.12 years after OEC therapy. They were divided into two groups based on the quality and quantity of their rehabilitative training: group A (n = 79) in sufficient rehabilitation (or active movement-target enhancement-neurorehabilitation therapy, AMTENT) and group B (n = 29) in insufficient rehabilitation. All patients were assessed by using the American Spinal Injury Association (ASIA) standard and the International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). Thirty-one patients were evaluated by the tests of magnetic resonance imaging (MRI), electromyography (EMG), and paravertebral sensory evoked potential (PVSEP). We found the following. 1) According to ASIA and IANR-SCIFRS assessment for all 108 patients, averaged motor scores increased from 37.79 ± 18.45 to 41.25 ± 18.18 (p < 0.01), light touch scores from 50.32 ± 24.71 to 55.90 ± 24.46 (p < 0.01), pin prick scores from 50.53 ± 24.92 to 54.53 ± 24.62 (p < 0.01); IANR-SCIFRS scores increased from 19.32 ± 9.98 to 23.12 ± 10.30 (p < 0.01). 2) The score changes in terms of motor, light touch, pin prick, and IANR-SCIFRS in group A were remarkably different (all p < 0.01). The score changes in group B were remarkably different in terms of motor (p < 0.05) and IANR-SCIFRS (p < 0.01), but not light touch or pin prick (p > 0.05). 3) Comparing group A with group B, the increased scores in terms of motor, light touch, and pin prick were remarkably different (all p < 0.01), but not IANR-SCIFRS (p > 0.05). 4) Fourteen of 108 patients (12.96%) became ASIA B from ASIA A; 18 of 108 (16.67%) became ASIA C from ASIA A. Nine of them (8.33%) improved their walk ability or made them rewalk by using a walker with or without assistance; 12 of 84 men (14.29%) improved their sex function. 5) MRI examinations were taken for 31 patients; there were no neoplasm, bleeding, swelling, cysts, neural tissue destruction or infection (abscess) or any other pathological changes in or around OEC transplant sites. 6) EMG examinations were done on 31 patients; 29 showed improvement and the remaining 2 had no change. PVSEP tests were performed in 31 patients; 28 showed improvements and the remaining 3 had no change. 7) No deterioration or complications were observed in our patients within the follow-up period. Our data suggest OEC therapy is safe and can improve neurological functions for patients with complete chronic SCI and ameliorate their quality of life; the AMTENT most likely plays a critical role in enhancing functional recovery after cell-based neurorestorotherapy. © 2012 Cognizant Comm. Corp.


Huang H.,Center for Neurorestoratology | Huang H.,Taishan Medical University | Chen L.,Center for Neurorestoratology | Chen L.,Taishan Medical University | Sanberg P.R.,University of South Florida
Cell Transplantation | Year: 2012

Neurorestoratology is a newborn and emerging distinct discipline in the neuroscience family. Its establishment will definitely speed up the advance of this promising frontier realm. A worldwide association for Neurorestoratology and several official journals covering this discipline have recently been set up. Clinical practice has demonstrated that the sequelae of damages and diseases of the CNS can be functionally restored to some degree. Obstacles that hinder the promising methods of Neurorestoratology to be translated from the bench to the bedside include political, governmental, religious, ethical, economic, and scientific factors or in most instances they work in combination. Falsehoods against the recognition of neurorestoratology include: 1) no therapeutic method is currently available that suggests that it is possible to repair, even partially, neurological functions; 2) according to the media, a cure will be very soon found for patients with severe spinal cord injury, brain trauma, and progressively deteriorated CNS degenerative diseases; 3) randomizing double blind control designed studies are the only gold standard for clinical study; self-comparison designed studies should be ignored and neglected. Future directions for neurorestoratology include the comparison and integration of current and upcoming available neurorestoration methods to look for the optimization regimes, and edit and publish clinical neurorestoratology treatment guidelines. © 2012 Cognizant Comm. Corp.


PubMed | Center for Neurorestoratology
Type: Journal Article | Journal: Cell transplantation | Year: 2010

Successful repair of damage in cerebral palsy (CP) needs effective clinical interventions other than simply symptomatic treatments. To elucidate the feasibility of using olfactory ensheathing cells (OECs) to treat CP in children and adolescents, we conducted a randomized controlled clinical trial (RCT) on 33 patients. The patients were randomly assigned into two groups (treatment group, n = 18; control group, n = 15), and OECs derived from aborted fetal tissue were injected into the bilateral corona radiata in the frontal lobes (a key point for neural network restoration, KPNNR). The Gross Motor Function Measure (GMFM-66) and the Caregiver Questionnaire Scale were used to evaluate the patients neurological function and overall health status. Among the 14 patients who completed the 6-month study, six received the cell transplantation and the other eight served as controls. In OEC treatment group, GMFM-66 scores were 26.67 +/- 25.33 compared with 19.00 +/- 20.00 for the control group. Concurrently, the Caregiver Questionnaire Scale score decreased to 77.83 +/- 15.99 in the treatment group in comparison to 138.66 +/- 64.06 of the control group. This trial, albeit small in sample size, indicates OEC KPNNR transplantation is effective for functional improvement in children and adolescents with CP, yet without obvious side effects. This small-scale study suggests that the procedure may be a plausible alternative method to treat this not yet curable disorder, and we urge further evaluation with a large-scale RCT.


PubMed | Center for Neurorestoratology
Type: | Journal: Cell transplantation | Year: 2012

Neurorestoratology is a newborn and emerging distinct discipline in the neuroscience family. Its establishment will definitely speed up the advance of this promising frontier realm. A worldwide association for Neurorestoratology and several official journals covering this discipline have recently been set up. Clinical practice has demonstrated that the sequelae of damages and diseases of the CNS can be functionally restored to some degree. Obstacles that hinder the promising methods of Neurorestoratology to be translated from the bench to the bedside include political, governmental, religious, ethical, economic, and scientific factors or in most instances they work in combination. Falsehoods against the recognition of neurorestoratology include: 1) no therapeutic method is currently available that suggests that it is possible to repair, even partially, neurological functions; 2) according to the media, a cure will be very soon found for patients with severe spinal cord injury, brain trauma, and progressively deteriorated CNS degenerative diseases; 3) randomizing double blind control designed studies are the only gold standard for clinical study; self-comparison designed studies should be ignored and neglected. Future directions for neurorestoratology include the comparison and integration of current and upcoming available neurorestoration methods to look for the optimization regimes, and edit and publish clinical neurorestoratology treatment guidelines.


PubMed | Center for Neurorestoratology
Type: | Journal: Cell transplantation | Year: 2012

The neurorestorative effect of the parenchymal transplantation of olfactory ensheathing cells (OECs) for cord trauma remains clinically controversial. The aim of this article is to study the long-term result of OECs for patients with complete chronic spinal cord injury (SCI). One hundred and eight patients suffered from complete chronic SCI were followed up successfully within the period of 3.47 1.12 years after OEC therapy. They were divided into two groups based on the quality and quantity of their rehabilitative training: group A (n = 79) in sufficient rehabilitation (or active movement-target enhancement-neurorehabilitation therapy, AMTENT) and group B (n = 29) in insufficient rehabilitation. All patients were assessed by using the American Spinal Injury Association (ASIA) standard and the International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS). Thirty-one patients were evaluated by the tests of magnetic resonance imaging (MRI), electromyography (EMG), and paravertebral sensory evoked potential (PVSEP). We found the following. 1) According to ASIA and IANR-SCIFRS assessment for all 108 patients, averaged motor scores increased from 37.79 18.45 to 41.25 18.18 (p < 0.01), light touch scores from 50.32 24.71 to 55.90 24.46 (p < 0.01), pin prick scores from 50.53 24.92 to 54.53 24.62 (p < 0.01); IANR-SCIFRS scores increased from 19.32 9.98 to 23.12 10.30 (p < 0.01). 2) The score changes in terms of motor, light touch, pin prick, and IANR-SCIFRS in group A were remarkably different (all p < 0.01). The score changes in group B were remarkably different in terms of motor (p < 0.05) and IANR-SCIFRS (p < 0.01), but not light touch or pin prick (p > 0.05). 3) Comparing group A with group B, the increased scores in terms of motor, light touch, and pin prick were remarkably different (all p < 0.01), but not IANR-SCIFRS (p > 0.05). 4) Fourteen of 108 patients (12.96%) became ASIA B from ASIA A; 18 of 108 (16.67%) became ASIA C from ASIA A. Nine of them (8.33%) improved their walk ability or made them rewalk by using a walker with or without assistance; 12 of 84 men (14.29%) improved their sex function. 5) MRI examinations were taken for 31 patients; there were no neoplasm, bleeding, swelling, cysts, neural tissue destruction or infection (abscess) or any other pathological changes in or around OEC transplant sites. 6) EMG examinations were done on 31 patients; 29 showed improvement and the remaining 2 had no change. PVSEP tests were performed in 31 patients; 28 showed improvements and the remaining 3 had no change. 7) No deterioration or complications were observed in our patients within the follow-up period. Our data suggest OEC therapy is safe and can improve neurological functions for patients with complete chronic SCI and ameliorate their quality of life; the AMTENT most likely plays a critical role in enhancing functional recovery after cell-based neurorestorotherapy.


PubMed | Center for Neurorestoratology
Type: | Journal: Cell transplantation | Year: 2012

Our previous series of studies have proven that olfactory ensheathing cell (OEC) transplantation appears to be able to slow the rate of clinical progression after OEC transplantation in the first 4 months and cell intracranial (key points for neural network restoration, KPNNR) and/or intraspinal (impaired segments) implants provide benefit for patients (including both the bulbar onset and limb onset subtypes) with amyotrophic lateral sclerosis (ALS). Here we report the results of cell therapy in patients with ALS on the basis of long-term observation following multiple transplants. From March of 2003 to January of 2010, 507 ALS patients received our cellular treatment. Among them, 42 patients underwent further OEC therapy by the route of KPNNR for two or more times (two times in 35 patients, three times in 5 patients, four times in 1 patient, and five times in 1 patient). The time intervals are 13.1 (6-60) months between the first therapy and the second one, 15.2 (8-24) months between the second therapy and the third one, 16 (6-26) months between the third therapy and the fourth one, and 9 months between the fourth therapy and the fifth time. All of the patients exhibited partial neurological functional recovery after each cell-based administration. Firstly, the scores of the ALS Functional Rating Scale (ALS-FRS) and ALS Norris Scale increased by 2.6 + 2.4 (0-8) and 4.9 + 5.2 (0-20) after the first treatment, 1.1 + 1.3 (0-5) and 2.3 + 2.9 (0-13) after the second treatment, 1.1 + 1.5 (0-4), and 3.4 + 6.9 (0-19) after the third treatment, 0.0 + 0.0 (0-0), and 2.5 + 3.5 (0-5) after the fourth treatment, and 1 point after the fifth cellular therapy, which were evaluated by independent neurologists. Secondly, the majority of patients have achieved improvement in electromyogram (EMG) assessments after the first, second, third, and fourth cell transplantation. After the first treatment, among the 42 patients, 36 (85.7%) patients EMG test results improved, the remaining 6 (14.3%) patients EMG results showed no remarkable change. After the second treatment, of the 42 patients, 30 (71.4%) patients EMG results improved, 11 (26.2%) patients showed no remarkable change, and 1 (2.4%) patient became worse. After the third treatment, out of the 7 patients, 4 (57.1%) patients improved, while the remaining 3 (42.9%) patients showed no change. Thirdly, the patients have partially recovered their breathing ability as demonstrated by pulmonary functional tests. After the first treatment, 20 (47.6%) patients pulmonary function ameliorated. After the second treatment, 18 (42.9%) patients pulmonary function improved. After the third treatment, 2 (28.6%) patients recovered some pulmonary function. After the fourth and fifth treatment, patients pulmonary function did not reveal significant change. The results show that multiple doses of cellular therapy definitely serve as a positive role in the treatment of ALS. This repeated and periodic cell-based therapy is strongly recommended for the patients, for better controlling this progressive deterioration disorder.

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