Bruce H Dobkin1, Armin Curt, James Guest. 1. Department of Neurology, Neurorehabilitation and Research Program, Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA 90095-1769, USA. bdobkin@mednet.ucla.edu
Abstract
BACKGROUND: In China, fetal brain tissue has been transplanted into the lesions of more than 400 patients with spinal cord injury (SCI). Anecdotal reports have been the only basis for assuming that the procedure is safe and effective. OBJECTIVE: To compare available reports to the experiences and objective findings of patients who received pre-operative and postoperative assessments before and up to 1 year after receiving cellular implants. METHODS: Independent observational study of 7 chronic SCI subjects undergoing surgery by Dr Hongyun Huang in Beijing. Assessments included lesion location by magnetic resonance imaging, protocol of the American Spinal Injury Association (ASIA), change in disability, and detailed history of the perioperative course. RESULTS: Inclusion and exclusion criteria were not clearly defined, as subjects with myelopathies graded ASIA A through D and of diverse causes were eligible. Cell injection sites did not always correlate with the level of injury and included the frontal lobes of a subject with a high cervical lesion. Complications, including meningitis, occurred in 5 subjects. Transient postoperative hypotonicity may have accounted for some physical changes. No clinically useful sensorimotor, disability, or autonomic improvements were found. CONCLUSIONS: The phenotype and the fate of the transplanted cells, described as olfactory ensheathing cells, are unknown. Perioperative morbidity and lack of functional benefit were identified as the most serious clinical shortcomings. The procedures observed did not attempt to meet international standards for either a safety or efficacy trial. In the absence of a valid clinical trials protocol, physicians should not recommend this procedure to patients.
BACKGROUND: In China, fetal brain tissue has been transplanted into the lesions of more than 400 patients with spinal cord injury (SCI). Anecdotal reports have been the only basis for assuming that the procedure is safe and effective. OBJECTIVE: To compare available reports to the experiences and objective findings of patients who received pre-operative and postoperative assessments before and up to 1 year after receiving cellular implants. METHODS: Independent observational study of 7 chronic SCI subjects undergoing surgery by Dr Hongyun Huang in Beijing. Assessments included lesion location by magnetic resonance imaging, protocol of the American Spinal Injury Association (ASIA), change in disability, and detailed history of the perioperative course. RESULTS: Inclusion and exclusion criteria were not clearly defined, as subjects with myelopathies graded ASIA A through D and of diverse causes were eligible. Cell injection sites did not always correlate with the level of injury and included the frontal lobes of a subject with a high cervical lesion. Complications, including meningitis, occurred in 5 subjects. Transient postoperative hypotonicity may have accounted for some physical changes. No clinically useful sensorimotor, disability, or autonomic improvements were found. CONCLUSIONS: The phenotype and the fate of the transplanted cells, described as olfactory ensheathing cells, are unknown. Perioperative morbidity and lack of functional benefit were identified as the most serious clinical shortcomings. The procedures observed did not attempt to meet international standards for either a safety or efficacy trial. In the absence of a valid clinical trials protocol, physicians should not recommend this procedure to patients.
Authors: M N Hadley; B C Walters; P A Grabb; N M Oyesiku; G J Przybylski; D K Resnick; T C Ryken Journal: Neurosurgery Date: 2002-03 Impact factor: 4.654
Authors: B Dobkin; H Barbeau; D Deforge; J Ditunno; R Elashoff; D Apple; M Basso; A Behrman; S Harkema; M Saulino; M Scott Journal: Neurorehabil Neural Repair Date: 2007 Jan-Feb Impact factor: 3.919
Authors: Sherif M Amr; Ashraf Gouda; Wael T Koptan; Ahmad A Galal; Dina Sabry Abdel-Fattah; Laila A Rashed; Hazem M Atta; Mohammad T Abdel-Aziz Journal: J Spinal Cord Med Date: 2013-11-26 Impact factor: 1.985