Listed below we summarize the facts regarding the clinical trials of the Xiao Procedure in patients with spinal cord injury (SCI) in the US and Germany. Some of the facts have already been included in the Open Letter of Complaint against the Xiao Procedure, others were recently found. We note that the SCI cases conducted by third parties all failed.
1. According to Dr. Xiao, he has “dedicated my live to SCI research since 1976″ [1]. The animal studies on cats [2] and clinical trials of 15 patients [3] are all for SCI.
2. Dr. Xiao’s papers on SCI were published “in highly regarded western journals” in 1999 and 2003, co-authored with Dr. de Groat, “the most respected name in bladder physiology” [4]. We note that, in his recent reviews [5, 6] on bladder function recovery after SCI, Dr. de Groat gave no word to Dr. Xiao’s work.
3. From 1999 to 2006, the NIH awarded Dr. Xiao more than 2.4 million dollars for the clinical trial in SCI at New York University (NYU) [7]. So far there is no official result released, except for a conference abstract [8] that reported two cases with much worse urodynamic results than Dr. Xiao’s first 15 SCI patients in China [3]. We note that NYU discontinued its clinical study after spending multi-million dollars for only two cases.
4. In December 2006, William Beaumont Hospitals started the clinical trial [9] in both SCI and spina bifida (SB). In Beaumont’s one-year clinical outcomes [10], no SCI case was reported. We know from media [11] that “the three with spinal cord injuries were not helped by the procedure”. More over, in May 2009, the mother of one of the Beaumont’s first SCI patients asked for help to buy catheters for her son [12].
5. In December 2009, Beaumont obtained a grant from the NIH for the clinical trial in SB [13]. The trial no longer includes SCI.
6. All of the 6 SCI cases in Tubingen, Germany have failed, “only 2 showed some improvement” [14].
7. Dr. Xiao blamed the failure of SCI cases to “incorrect patient selection” and “inappropriate postoperative care” [14]. In at least two of his posts on Chinese forums [15, 16], he further blamed the misuse of Ditropan. But according the mother of the patient [17], patients had already been required to quit Ditropan.
Reference
[1] http://sci.rutgers.edu/forum/showpost.php?p=1183019&postcount=36
[2] Xiao CG, de Groat WC, Godec CJ, Dai C and Xiao Q (1999). “Skin-CNS-bladder” reflex pathway for micturition after spinal cord injury and its underlying mechanisms. J Urol 162: 936-42.
[3] Xiao CG, Du MX, Dai C, Li B, Nitti VW and de Groat WC (2003). An artificial somatic-central nervous system-autonomic reflex pathway for controllable micturition after spinal cord injury: preliminary results in 15 patients. J Urol 170: 1237-41.
[4] http://sci.rutgers.edu/forum/showpost.php?p=1118680&postcount=33
[5] de Groat WC, Yoshimura N. Mechanisms underlying the recovery of lower urinary tract function following spinal cord injury. Progress in Brain Research. 2006;152:59-84.
[6] Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nature Reviews Neuroscience. 2008 Jun;9(6):453-66.
[7] http://www.researchgrantdatabase.com/g/5R01DK053063-05/SKIN-CNS-BLADDER-REFLEX-ARC-FOR-MICTURITION-AFTER-SCI/
[8] http://www.urotoday.com/264/conference_reports/selected_abstracts/female_urology__part_10.html
[9] http://www.clinicaltrials.gov/ct/show/NCT00378664
[10] http://linkinghub.elsevier.com/retrieve/pii/S0022534709608843
[11] http://www.tampabay.com/features/humaninterest/article984049.ece
[12] http://sci.rutgers.edu/forum/showthread.php?t=118791
[13] http://projectreporter.nih.gov/project_info_description.cfm?aid=7696321
[14] http://webcasts.prous.com/netadmin/webcast_viewer/Preview.aspx?type=0&lid=10196&pv=2
[15] http://www.chinagonet.com/main/view_post.php?pid=2251853
[16] http://www.starlakeporch.net/bbs/read.php?1,52103,52175#msg-52175
[17] http://sci.rutgers.edu/forum/showpost.php?p=586207&postcount=34