Name of journal: World Journal of Transplantation esps manuscript no: 18452 Manuscript Type: Original Article Retrospective Study

RESULTS

General efficacy of the intrathecal transplantation of HSCs and HPs

Clinical efficacy was evaluated after three years of therapy by standard neurologic examination and registration of the results in specifically developed forms. The analysis of the registered data demonstrated efficacy of the intrathecal transplantation of HSCs and HPs in 57.4% of the patients, concerning motor and sensitive restoration, as well as repair of bowel and bladder functions (Figure 2). As it can be seen from Figure 2, we observed no neurologic improvement in 42.6% cases, which can be explained by underdeveloped inclusion/exclusion criteria. To date, it is clear that the method demands rigorous screening of the patients for this therapy that will further entail the development of clearer indications and contraindications for the intrathecal transplantation of HSCs and HPs. The size of lesion, its location, type and anatomic continuity of bone structures were of prior importance in this therapy. The analysis of ineffective cases of HSCs and HPs transplantation showed that in major part of the cases (25.2%) the size of spinal cord (SC) lesion exceeded 50% of the spinal cord cross-wise and one segment long-wise, according to MRI. Other reason for the inefficacy of the intrathecal transplantation of HSCs and HPs seems to be the unnoticed moderate or slight disorder of CSF circulation, associated with CSF hypertension, instability of the spinal segment in the injury site and/or scars and cicatrices of the spinal cord that hinder the circulation of CSF. Refusal of the patients from rehabilitative therapy (40.6% of cases) has also significantly contributed to the inefficacy of the therapy. The patients considered administered transplantations sufficient for the recovery and neglected the rehabilitation. In 10.6% cases, the patients negated positive results of the therapy, although the medical exercise instructors and attending doctors observed neurologic progress. Only video records that were taken in the beginning of the treatment and in the course of it, served a decisive argument to confirm functional repair. The therapy that took from 5 to 8 years showed that these patients demonstrated good clinical results of SC functions’ repair. However, this trial included only the patients who received no less than 20 transplantations of HSCs and HPs. In other cases (8.2%) the reason of inefficacy remained unclear, prompting necessity of further research. Moreover, we did not find correlation between the number of transplanted HSCs and HPs and transplantation efficacy [P = 0.1 (P > 0.1)], which was also confirmed by the absence of difference between the number of the transplanted cells to the patients with no effect and those with positive effect, resulting from HSCs and HPs transplantation (5.3 ± 0.9 × 10⁶, as compared to 106.4 ± 0.9 × 10⁶, P > 0.1, respectively). The hypothesis that the process of repair after intrathecal administration of HSCs and PCS depends on the amount of the cells (5.3  0.9  10⁶ as compared to 106.4  0.9  10⁶) was not confirmed at a 90% significance level.