Moleac releases results from the SATURN study, published in The Journal of Spinal Cord Medicine.
Spinal cord injury (SCI) carries debilitating consequences with severe neurological and functional deficits, deteriorating the quality of life for survivors and their relatives. To date, there is no way to reverse spinal cord damage, and new treatments are always sought, including prostheses, devices and medications, to improve motor function and function recovery in SCI.
NeuroAiD has well established neuroprotective and neurorepair properties that enhance neurological recovery on top of rehabilitation in stroke and traumatic brain injury. It could represent a new therapeutic approach for SCI patients.
The SATURN (Spinal cord injury Assessing Tolerability and Use of combined Rehabilitation and NeuroAiD) study was designed to evaluate the safety and potential role of NeuroAiD in subjects suffering from severe SCI. This pilot study included 30 subjects with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A and B, who received a 6-month course of NeuroAiD on top of standard care and rehabilitation.
The key endpoints were the safety profile by measuring the occurrence of adverse events (AEs) during the 6-month course of NeuroAiD and the improvements in the AIS grade and motor score at month 6.
SATURN Study Key Findings
- A total of 14 AEs were reported by 10 patients, none being deemed definitely, likely or possibly related to NeuroAiD.
- 33% of patients improved their AIS score at month 6 from baseline, with improvement in 25% and 50% of patients in the AIS A and AIS B groups, respectively. One patient has even achieved complete recovery (grade E).
- The Asia total motor score improved over time from 17.1 at baseline to 49.9 at month 6.
Of note, the investigators pointed out that the improvement rates during the 6-month course of NeuroAiD appear to be higher than the previously reported spontaneous recovery rates of approximately 10% from grade A to grade B and 10 % at grade C, 80% of patients remaining at grade A.
“Any improvement in AIS grading is clinically important for SCI patients,” said Prof. Ramesh Kumar, neurosurgeon at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. “The rates of improvement we saw at 6 months in our study with NeuroAiD in this severe SCI sample with excellent safety, are very encouraging to use and to develop it as a complementary therapeutic option.”
[Source(s): Moleac, PR Newswire]