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Wednesday, October 11, 2017 11:34:37 PM
From the report
-Quick summary of what SAE and AE's stand for per the Journal of Clinical Medical Research below,
"Serious adverse events
(SAEs) are defined as any event that is fatal or life-threatening,
led to hospitalizations, or required major medical intervention.
All other events, side effects, or patient complaints/discomforts
were collected as adverse events (AEs).
Overall, the procedures demonstrated a strong safety profile
with very few reported SAEs or AEs. Figure 4 shows a summary
of the patient reported SAEs and AEs by injection type.
A total of 23 AEs and four SAEs were reported throughout the 12-month follow-up period. This corresponds to 3.4% AEs and 0.59% SAEs for SVF injections. Figure 5 shows the total
number of patients per indications with total numbers in parentheses.
Reported SAEs and AEs by indication are shown
by percentage in red. Note that some patients reported more
than one indication or disease. Patients with various neurological
diseases had greater than 84% safety profile (i.e. four
AEs out of 25 patients) indicating a very solid safety record for
intrathecal injections. Other neurological indications such as
Parkinson’s and multiple sclerosis had a higher safety percent
Conclusion
Our reported results from five treatment centers in the United
States demonstrate the overall safety of autologous stem cell
therapy using stem cells from the SVF collected from liposuction
of fat tissue. The few serious adverse side effects reported
were deemed most likely not related to stem cell therapy
received nor to the procedure used. Consequently, our paper
adds further documentation to the global safety record of adult
stem cell therapy."
Consent
All patients were consented and agreed to participate in treatments.
Competing Interests
KC is an officer of US Stem Cell, Inc.
Funding
This study was partially funded by US Stem Cell, Inc.
Author Contributions
All authors participated in clinic patient treatments and data
collection. KC analyzed the data and wrote the manuscript. All
authors read and approved the final manuscript.
Plus this in July https://www.dovepress.com/first-in-man-intraglandular-implantation-of-stromal-vascular-fraction--peer-reviewed-article-IMCRJ
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