MESENCHYMAL STEM CELL THERAPY FOR DEGENERATIVE DISC DISEASE

INTRODUCTION

Degenerative Disc Disease (DDD) is a general term used to describe abnormal changes or deterioration that occur in the discs of the spine due to age, which can cause back or neck pain. Spinal discs are soft and compressible, so they act as shock absorbers between the vertebrae, or bones, of the spinal column. They help keep your back flexible, allowing you to bend and twist. However, these discs begin to wear out as you age, putting extra pressure on the nerves and spinal cord, which can lead to pain and even impair nerve function. There are various surgical and pharmacological treatments. But advanced research into developing new treatments now focus on regenerative medicine,such as mesenchymal stem cell (MSC) therapy that can slow down the degenerative pathophysiological process and demonstrates successful results.

CLINICAL AND DEMOGRAPHIC DATA

At bioXcellerator, 316 patients with degenerative disc disease have been treated with MSC therapy from September 2020 to September 2022.

Gender and age

The population treated is predominantly male (see figure 2), ranging from 21 to 85 years in age. Half of the patients were less than 47 years of age.

2-3

Country of origin

Patients from more than 24 countries have visited us for treatment for DDD, mostly from the United States (82%) and Canada (5.1%) as shown and to a lesser extent by other countries represented in Figure 3.

4-1

TREATMENT DATA

Affected vertebral level
The following is the distribution of affected discs per spinal segment.

INSTRUMENTS TO MEASURE THE CLINICAL EFFECT OF TREATMENT

Visual Analog Pain Scale - VAS: used to measure pain intensity, ranging from 0 (no pain) to 10
(extreme pain).

Oswestry Disability Index – ODI: used to quantify disability related to low back pain and consists of 10 questions. The final score ranges from 0 to 100, with the following interpretation: 0% to 20% - minimal disability, 21%-40% - moderate disability, 41%-60% - severe disability, 61%-80% - disabled, 81%-100% - prostration. The percentage changes are calculated based on the total available scores. So, a change from 20 to 10, with a total range of 0 to 100, would represent a 10% decrease.

Neck Disability Index - NDI: the NDI includes 10 questions and is used to determine how neck pain affects a patient's daily life and to assess the self-reported disability of patients with neck pain. The final score ranges from 0 (no disability) to 100 (total disability). The percentage changes are calculated based on the total available scores. So, a change from 20 to 10, with a total range of 0 to 100, would represent a 10% decrease.

FOLLOW-UP OUTCOMES AND FINDINGS

A sample of 30 (10% of patients treated) had completed follow-up for up to 6 months using all 3 assessment scales. Figure 6 shows the progression of pain using the VAS. Figure 7 shows the improvement of physical limitation measured with the NDI for patients with cervical DDD. Figure 8 shows the improvement of physical limitation, measured with the ODI scale for patients with DDD of the non-cervical segments.

An overall decrease in pain is observed at
six months post-treatment relative to
baseline, and an improvement in pain over
time between three and six months after
receiving MSC treatment. The median of
the VAS was reduced from 5 points at
baseline to 2 points at 6 months after
treatment.

A reduction in disability was observed for
the thoracic and lumbosacral spine, from
the baseline or pre-therapy measurement
and up to the post-treatment
measurements at 3 and 6 months. This
indicated that over time, cases with
moderate to severe disability improve to
states of minimal to moderate disabil

A reduction in disability was also observed
in patients treated with DDD of the cervical
spine, from baseline or pre-therapy
measurement to post-treatment
measurements at 3 and 6 months. This was
observed in cases of moderate to complete
disability who improved to states of no
disability or minimal disability at 6-month
follow-up.

CONCLUSION

Our review of patients treated at bioXcellerator between September 2020 and September 2022 demonstrates an improvement in pain and functional limitation of patients with DDD at all segments of the spine when evaluated with clinical scales at 3 and 6 months in comparison to the pre-therapy baseline evaluation.

This report was prepared by Scientific Direction Board from internal data sources on November 01, 2022.

MESENCHYMAL STEM CELL THERAPYFOR DEGENERATIVE DISC DISEASE