SPINAL CORD INJURY -SCITREATED WITH STEM CELLTHERAPY

Introduction

Spinal Cord Injury -SCI- is a damage on spinal nerves, body's central and most important nerve bundle, because of backbone trauma. SCI is commonly called a broken neck or broken back. Most cases of SCI patients at Bioxcellerator were caused by trauma that breaks and squeezes vertebrae or bones in the back, damaging axons; the long nerve cell "wires" that pass-through vertebra, carrying signals between the brain and body. Stem cell therapy facilitates the natural repair of nerve tissue in spinal cord and nerve roots. The SCI is classified by injury level and severity:

• Injury level is determined by the lowest point on the spinal cord where sensory feeling and motor movement diminish or disappear. Trauma or SCI can occur in a segment of cervical, thoracic, or lumbosacral cord.

• SCI severity is subclassified into 2 grades:

          1)  Complete injury: is so severe that almost all feeling (sensory function), and movement control ability (motor function)    are lost below the SCI area

         2) Incomplete injury: occurs when there is some sensory or motor function below the SCI area. There are many degrees of incomplete injury.

Mesenchymal Stem Cells (MSCs) therapy can potentially support the microenvironment to improve the SCI by modulating the inflammatory response, increasing vascularity, and promoting the natural repair process.

Demographic and clinical data

Bioxcellerator treated 32 SCI patients between 2019 and 2021. The baseline clinical characteristics of SCI patients treated with MSCs therapy are presented below.

Treatment data

The clinical protocol treatment for SCI patients includes 4 trips for MSCs therapy and clinical
follow-up.

Outcome measurement and findings

Progression or improvement Measurement of SCI patients is evaluated with the American Spinal Injury Association (ASIA) scale, by motor and sensory functions, and injury severity. At Bioxcellerator, physicians use this tool to assess a patient's progress on each trip in which therapy with Mesenchymal Stem Cells in the Wharton's Jelly is administered.

Measurement of upper and lower extremity strength is scored from 0 (completely paralyzed limb) to 5 (active movement and full range of motion against maximal resistance) for each limb. Deep and superficial sensation is also evaluated. Scores for each component and each limb (upper and lower) are presented from 0 to 100. Higher scores correspond to better recovery.

Findings on the ASIA scale can be classified as follows:

• Grade A: The impairment is complete. There is no motor or sensory function left below the level of injury.
• Grade B: The impairment is incomplete. Sensory function, but not motor function, is preserved below the neurologic level (the first normal level above the level of injury) and some sensation is preserved in the sacral segments S4 and S5.
• Grade C: The impairment is incomplete. Motor function is preserved below the neurologic level, but more than half of the key muscles below the neurologic level have a muscle grade less than 3 (they are not strong enough to move against gravity).
• Grade D: The impairment is incomplete. Motor function is preserved below the neurologic level, and at least half of the key muscles below the neurologic level have a muscle grade of 3 or more (the joints can be moved against gravity).
• Grade E: The patient's functions are normal. All motor and sensory functions are unhindered.

According to ASIA results, most of our patients (79%) presented complete SCI, followed by grade B incomplete injury (14%).

"Pin prick" type sensitivity 

According to sensitivity score the improvement in “pin prick” was evident from the third trip, going from a median of 46 points to 54 points, with an increase of 8 points, which means an increase of about 17,3% on the overall punctuation, for all body segments. This indicates that for MSCs treatment to show improvement in deep sensitivity in SCI patients, is required a minimum of three stem cell treatment-trips.

"Light touch" type sensitivity:
There was no significant effect on the increase of the score in superficial type sensitivity or "light touch" in any of the stem cell treatment trips. This would seem to indicate that improvement in sensitivity may be better seen in 'coarse' than in 'fine' sensitivity. However,several of our SCI patients had not completed their treatment-trips, so it is possible thatwhen a greater number of records become available, this trend may be favourable for thisresult.

ASIA motor score on limbs evaluation:
Our results show an improvement in motor function in SCI patients, going from a basal median of 12 to 18 points at the third trip, with an increase of 6 points, which means an increase of about 50% on the overall punctuation. This indicates that for MSCs treatment to show improvement in motor function in SCI patients, is required a minimum of two stem cell treatment-trips.

Other significant findings

It was evidenced that the SCI patients who complete a protocol of four treatment trips,significantly improve their sensory level, strength and mobility of their hands and can-do activities such as putting on and taking off their shirt, combing their hair, brushing their teeth, and eating alone.

SCI patients with incomplete protocols of two treatment trips have reported improvement in their energy levels, greater sleep conciliation and control of abdominal muscles; and a reduction in painkillers need.

Some of our SCI patients have notified us, that they have shown a progressive and gradual increase in muscle strength in arms and legs, and greater ease of muscle movement, and a decrease in spasms and stiffness.

Additionally, some SCI patients have reported a subjective reduction in the severity of their neuropathy by up to 75%, and in neuropathic pain. Other patients (with complete SCI) report improvement of anal and urinary sphincters control.

This report was prepared by Scientific Direction team from institutional data sources on January 25, 2022.