Feasibility and Safety of Neural Tissue Transplantation in Patients with Syringomyelia

Abstract

Transplantation of fetal spinal cord (FSC) tissue has demonstrated significant potential in animal models for achieving partial anatomical and functional restoration following spinal cord injury (SCI). To determine whether this strategy can eventually be translated to humans with SCI, a pilot safety and feasibility study was initiated in patients with progressive posttraumatic syringomyelia (PPTS). A total of eight patients with PPTS have been enrolled to date, and this report presents findings for the first two patients through 18 months postoperative. The study design included detailed assessments of each subject at multiple pre- and postoperative time points. Outcome data were then compared with each subject's own baseline. The surgical protocol included detethering, cyst drainage, and implantation of 6-9-week postconception human FSC tissue. Immunosuppression with cyclosporine was initiated a few days prior to surgery and continued for 6 months postoperatively. Key outcome measures included: serial magnetic resonance imaging (MRI) exams, standardized measures of neurological impairment and functional disability, detailed pain assessment, and extensive neurophysiological testing. Through 18 months, the first two patients have been stable neurologically and the MRIs have shown evidence of solid tissue at the graft sites, without evidence of donor tissue overgrowth. Although it is still too soon to draw any firm conclusions, the findings from the initial two patients in this study suggest that intraspinal grafting of human FSC tissue is both feasible and safe.

A Systematic Review of Cellular Transplantation Therapies for Spinal Cord Injury

“…No detrimental (or beneficial) effect was reported in the first four patients. While it has been possible to identify SC cables using MRI in rats (Iannotti et al, 2002) and fetal tissue transplants in the human spinal cord (Wirth et al, 2001), MRI failed to identify the SC transplants in the study by Saberi and colleagues. This trial, following ICCP guidelines, is a promising first step in the move toward human translation of SCs in SCI.…”

Surgical treatment of post-traumatic syringomyelia

“…In addition to the two main strategies of laminectomy, with the breakdown of adhesions and direct syrinx drainage procedures, there are treatments such as cordectomy, omental grafting and neural tissue transplantation. 6,15,16 Laminectomy with duroplasty is reported as resulting in improvement or stabilization of symptoms in 70-85% of patients and in a continued deterioration of symptoms in 15-30% of patients. 17,18 Shunting seems to produce less good results, 2,13 although some may contest this claim.…”

Rapid recovery of segmental neurological function in a tetraplegic patient following transplantation of fetal olfactory bulb-derived cells

“…Grafts of embryonic brain and spinal cord tissue have been reported to survive in the spinal cord [46][47][48][49][50][51] of experimental animals and considerable experimental data from animal studies indicate that transplanted fetal spinal cord tissue improves recovery from SCI. 52,53 Fetal spinal cord tissue has previously been transplanted into patients with chronic SCI and symptomatic syringomyelia without reports of adverse events [54][55][56] and there is only one definitive report of tumor growth following CNS transplantation of fetal tissue in a patient. 57 While OEGs are very interesting cells with therapeutic potential, many important steps that normally are considered the essential groundwork of a clinical trial have not been completed for fetal OB-derived cell transplantation.…”