scholarly journals Neuro-Spinal Scaffold"! Implantation in Patients with Acute Traumatic Thoracic Complete Spinal Cord Injury: 24 Month Results From the INSPIRE Study

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Kee D Kim ◽  
K Stuart Lee ◽  
Jason J Chang ◽  
Richard M Toselli
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Natural History ◽  
Primary Endpoint ◽  
Conversion Rate ◽  
Clinical Investigation ◽  
Open Label ◽  
Cord Injury ◽  
Complete Spinal Cord Injury

Abstract INTRODUCTION The Neuro-Spinal Scaffold"! (NSS) is an investigational biodegradable device developed to facilitate spinal cord repair following intraparenchymal implantation within the injured spinal cord. An open-label, single-arm, multicenter clinical study was conducted to evaluate the safety and efficacy of the device in acute thoracic complete spinal cord injury (SCI). Here, we report on available 24-mo follow-up data. METHODS The INSPIRE Study (NCT02138110) enrolled patients with nonpenetrating, thoracic (T2-T12/L1) AIS A SCI within 96 h of injury. Safety and neurological outcomes were assessed. The primary endpoint was AIS conversion rate at 6 mo. The study included an Objective Performance Criterion (OPC) defined as at least 25% of patients demonstrating an AIS grade improvement at 6 mo, which was derived from a 16% natural history AIS conversion rate in the studied patient population.[1] RESULTS A total of 19 patients were implanted with the NSS. There were 3 deaths determined by investigators to be unrelated to the NSS or its implantation. A total of 8 patients have completed the 24-mo assessment visit, with additional follow-up ongoing. Seven of the sixteen patients who reached the 6-mo primary endpoint visit experienced an AIS grade improvement (43.8%; AIS B, n = 5; AIS C, n = 2). Three of the five patients who converted to AIS B experienced further improvement to AIS C at 12 (n = 2) and 24 mo (n = 1) postinjury. At last follow-up, none of the patients with AIS conversion had deteriorated and there were no unanticipated or serious adverse device effects related to the NSS or its implantation as determined by investigators. CONCLUSION The INSPIRE study is the first to clinically evaluate implantation of a scaffold as a treatment for acute SCI. This study describes the safety of the NSS and feasibility of implantation. The AIS conversion rate exceeds published natural history rates and the OPC. Available results at twenty-four months continue to support further clinical investigation.

The natural history of complete spinal cord injury: a pooled analysis of 1162 patients and a meta-analysis of modern data

2018 ◽  
Vol 28 (4) ◽  
pp. 436-443 ◽  
Author(s):  
Najib E. El Tecle ◽  
Nader S. Dahdaleh ◽  
Mohamad Bydon ◽  
Wilson Z. Ray ◽  
James C. Torner ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Natural History ◽  
Conversion Rate ◽  
Observational Studies ◽  
Meta Analysis ◽  
Early Surgery ◽  
Cord Injury ◽  
History Of ◽  
Complete Spinal Cord Injury

OBJECTIVEThe natural history of complete spinal cord injury (SCI) is poorly studied. The classically quoted rate of improvement or conversion for patients with American Spinal Injury Association (ASIA) grade A (ASIA A) injuries is 15%–20%; however, data supporting this rate are very limited. In this paper, the authors conducted a meta-analysis of modern data reporting on ASIA A patients and evaluated factors affecting the natural history of the disease.METHODSThe authors conducted a systematic literature review of all randomized clinical trials (RCTs) and observational studies of patients with traumatic SCI. The Embase, MEDLINE, PubMed, Scopus, CINAHL, and Cochrane databases were reviewed for all studies reporting on SCI and published after 1992. A meta-analysis was conducted using the DerSimonian and Laird (random-effects) model with a summary odds ratio analysis.RESULTSEleven RCTs and 9 observational studies were included in the final analysis. Overall, the 20 included studies reported on 1162 patients with ASIA A injuries. The overall conversion rate was 28.1%, with 327 of 1162 patients improving to at least ASIA B. The overall rate of conversion noted in cervical spine injuries was 33.3%, whereas that in thoracic injuries was 30.6%. Patients undergoing early surgery had a higher rate of conversion (46.1%) than patients undergoing late surgery (25%) (OR 2.31, 95% CI 1.08–4.96, p = 0.03).CONCLUSIONSThe overall rate of conversion of ASIA A SCIs from pooled data of prospective trials and observational series is 28.1%. This rate of conversion is higher than what is reported in the literature. Early surgery is predictive of a higher conversion rate. However, there are not enough data to provide conclusions pertaining to the efficacy of biological and medical therapies.

scholarly journals A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study

2021 ◽  
pp. 1-10
Author(s):  
Kee D. Kim ◽  
K. Stuart Lee ◽  
Domagoj Coric ◽  
Jason J. Chang ◽  
James S. Harrop ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Conversion Rate ◽  
Neurological Recovery ◽  
Thoracic Spinal Cord ◽  
Intramedullary Spinal Cord ◽  
Cord Injury ◽  
Bioresorbable Polymer ◽  
Implantation Procedure

OBJECTIVEThe aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2–12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.METHODSThis was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.RESULTSNineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.CONCLUSIONSIn this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.Clinical trial registration no.: NCT02138110 (clinicaltrials.gov)

scholarly journals Racial and Ethnic Disparities in Functioning at Discharge and Follow-Up Among Patients With Motor Complete Spinal Cord Injury

2014 ◽  
Vol 95 (11) ◽  
pp. 2140-2151 ◽  
Author(s):  
Denise C. Fyffe ◽  
Anne Deutsch ◽  
Amanda L. Botticello ◽  
Steven Kirshblum ◽  
Kenneth J. Ottenbacher
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Ethnic Disparities ◽  
Racial And Ethnic Disparities ◽  
Cord Injury ◽  
Complete Spinal Cord Injury

scholarly journals Stem Cell Research in Bangladesh: Neurosurgical Perspective

2019 ◽  
Vol 9 (1) ◽  
pp. 3-10
Author(s):  
Sukriti Das ◽  
Hasan Mahbub ◽  
Mamunur Rashid ◽  
Asit Chandra Sarker ◽  
Sharbari Dey ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Bone Marrow ◽  
Spinal Cord Injury ◽  
Stem Cell ◽  
Stem Cell Research ◽  
Autologous Bone Marrow ◽  
Cord Injury ◽  
Autologous Bone ◽  
Complete Spinal Cord Injury

Purpose: Traumatic spinal cord injury (SCI) is a severe neurological disease which causes sensory loss, motor paralysis and autonomic difficulties which is usually treated with physiotherapy. Complete spinal cord injury with ASIA Grade A patients remains untreated and neglected in our country since long back. Here we describe an effective strategy for the treatment of complete spinal cord injury by autologous bone marrow derived stem cell. Material and Method: The study was conducted in the Neurosurgery department, Dhaka Medical College Hospital, Dhaka, Bangladesh from January, 2016 to January 2019. Total 22 Patients with spinal cord injury (ASIA Grade-A) were included in this study. Total 60 ml of autologous bone marrow was aspirated and processed to prepare 6-7 ml of bone marrow aspirate concentrate (BMAC) which was transplanted at the site of cord injury. Bony alignment was done by decompression and stabilization. Post-surgical physiotherapy and regular follow up was given. Result: Surgical outcome was assessed by ASIA Grading. Among 22 patients, 10 patients (45.45%) improved by one grade, 7 patients (31.82%) improved by two grade, 2 patients (9.09%) improved by three grade, 3 patients (13.64%) did not show any improvement of any grade as because their follow-up period was less than 6 months. 19 patients (86.36%) noticed sensory, 16 patients (72.72%) noticed bladder improvement and 19 patients (86.36%) noticed bowel improvement to some extent. Conclusion: Stem cell therapy is safe and effective. Steady and focused progress in stem cell research will open the door for many disable patients in the country like Bangladesh. Bang. J Neurosurgery 2019; 9(1): 3-10

scholarly journals Natural History of Isolated Below-Knee Vein Thrombosis in Patients with Spinal Cord Injury

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 861
Author(s):  
Jang-Hyuk Cho ◽  
Dong-Gyu Lee
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Deep Vein Thrombosis ◽  
Natural History ◽  
Vein Thrombosis ◽  
Asian Patients ◽  
Cord Injury ◽  
History Of ◽  
Deep Vein

In the general population, serial imaging is recommended over anticoagulant therapy for below-knee deep vein thrombosis (BKDVT). However, no clinical trial in Asian patients with spinal cord injury and BKDVT has been performed. Therefore, we evaluated the natural course of BKDVT in patients with acute spinal cord injury. We retrospectively analyzed inpatients with spinal cord injury with BKDVT between 2016 and 2020. All patients underwent inpatient rehabilitation treatment and duplex ultrasonographic examination of both the lower extremities at follow-up. After screening 172 patients with acute spinal cord injury for deep vein thrombosis using duplex ultrasound, 27 patients with below-the-knee deep vein thrombosis were included in this study. The mean lower-extremity motor score (median, interquartile range) was 66.0, 54.0–74.5. Sixteen patients received a non-vitamin K antagonist oral anticoagulant (NOAC) for anticoagulation. None of the patients had proximal propagation according to the follow-up duplex ultrasonography. BKDVT disappearance was not significantly different between the NOAC treatment and non-treatment groups. Asian patients with spinal cord injury have a low incidence of venous thromboembolism and favorable natural history of BKDVT. We recommend serial imaging over anticoagulant therapy for BKDVT in these patients.

Long-Term Follow-Up After Spinal Cord Injury in Canada

2006 ◽  
Author(s):  
Mark I. Tonack ◽  
Sander L. Hitzig ◽  
B. Catharine Craven ◽  
Kent A. Campbell ◽  
Kathryn A. Boschen ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Cord Injury ◽  
Long Term Follow Up
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