Page 99 - ITPS-7-2

INNOSC Theranostics and
Pharmacological Sciences ABT for NDO

walls. Clarix Flo is a sterile, micronized human AM product based on their responses to the Qualiveen questionnaire
that is derived from the placenta and umbilical cord and (Figure 1). After injection, all eight patients reported a
is aseptically processed and manufactured from donated significant decrease in the severity of their urinary tract
human birth tissues according to regulations established by symptoms as the average Qualiveen score decreased from
the US Food and Drug Administration. The micronized AM 3.9 ± 0.17 at baseline to 2.9 ± 0.21 at post-ABT week 2
is terminally sterilized through gamma irradiation and does (P < 0.01), 2.1 ± 0.53 at post-ABT week 4 (P < 0.01), and
not contain live cells but retains the natural extracellular 1.4 ± 0.20 at post-ABT week 8 (P < 0.01). A considerable
matrix components innate to the AM tissue. 6 decrease in symptomatic impact on their daily lives was
noted in all four categories of the Qualiveen. Furthermore,
Descriptive statistics for continuous variables are their symptoms remained relatively stable when measured
reported as the mean ± standard deviation (SD), and at post-ABT week 12 with a reported embarrassment score
statistical analysis was performed using the R software of 1.39 ± 0.08, a constraint score of 1.42 ± 0.09, a fear score
version 4.1.3 (R Core Team, Austria). The differences of 1.45 ± 0.09, and a QoL score of 1.3 ± 0.19 (Figure 1, all
between parameters before and after treatment were P < 0.01 as compared to baseline).
analyzed with paired t-tests. A P-value < 0.05 was
considered statistically significant. In addition, all eight patients included in the current
study reported a significant increase in their first volume
3. Results IDC and MCC and a decrease in MDP for at least 3 months
following treatment. The patient’s pre-treatment MCC was
Eight consecutive patients (female [n = 5] and male [n = 3]) 208.63 ± 34.98 mL, and MDP was 67.38 ± 2.88 cmH O.
with an average age of 39.6 ± 13.6 years (23 – 65 years) met the At 4 weeks following micronized AM treatment, MCC
2
inclusion criteria and were included in the current study. On
average, the patients experienced symptoms of the neurogenic was increased to 430.25 ± 32.4 mL (P < 0.01), and MDP
was decreased to 33 ± 1.2 cmH O (P < 0.01). At 12 weeks
bladder (NGB) for 9.4 (6.2 – 13.8) years and had tried multiple following treatment, MCC and MDP remained relatively
2
therapies, including anticholinergics (n = 7), beta-3 adrenergic the same at 427.25 ± 24.9 mL and 33.38 ± 1.85 cmH O,
agonists (n = 8), and Botox injection (n = 8). All patients respectively. The post-treatment mean detrusor
2
initially responded to intravesical botulinum toxin A but had compliance increased from 27.5 ± 10.6 mL/cm water to
a decreased response after 3 – 4 years. All patients had SCI 65 ± 15.2 mL/cm water at week 4 and subsequently to
with lesions at or above the T-6 level (Table 1). In addition, 63 ± 14.4 mL/cm water at week 12 (Table 2). Furthermore,
before treatment with AM, none of the included patients were at 12 weeks following injection, all patients were completely
completely continent on clean intermittent catheterization continent on CIC.
(CIC), although all used self-catheterization to empty their
bladders. After ABT, all patients were completely continent We also evaluated the frequency of AD in all eight
between CIC and continued to use self-catheterization to patients at baseline and weeks following treatment with
empty their bladders every 4 – 6 h. The severity of the injury, micronized AM. Before treatment, all eight patients
as evaluated by the American Spinal Injury Association experienced symptoms either daily or every other day.
impairment scale, was grade A in 100% of patients. All patients reported improvements in their symptoms
by week 2, and at week 12, all eight patients reported no
Before micronized AM treatment, all the patients symptoms of AD (Table 3).
reported a high symptomatic impact on their daily lives

Table 1. Patient demographics

Patient Age (years) Neurological Upper motor neuron
level bladder dysfunction
1 37 T6 Complete
2 29 T3 Complete
3 31 T6 Complete
4 35 C7 Complete
5 47 C6 Complete
6 23 T4 Complete
7 50 C5/6 Complete
Figure 1. Qualiveen questionnaire scores before and after amniotic
8 65 C2 Complete
bladder therapy.

Volume 7 Issue 2 (2024) 3 doi: 10.36922/itps.2037