Wednesday, October 18, 2023

IMAGING REVIEW OF SERUM PERFORMANCE CASE STUDY: EXOSOMES TOPICAL PRODUCT (part 2)

INTRODUCTION:

Sept 8, 2023- an independent single-case evaluation study (also known as a PHASE ONE performance study) of the effects of a commercial skin topical product conducted by the Bard Diagnostic Imaging & Research Lab. The test drive was coordinated in part by the academic publishing and research administrators of the Integrative Health Research Center.  

DISCLAIMER: This study is conducted as an impartial anecdotal test drive and report for public information.  This product review was designed as an academic review of imaging technologies and the effect of the exosome-based product clinically supervised by Dr. Robert Bard (diagnostic imaging specialist and Sr. Research Advisor to HealthTech Reporter projects).   This study is not in any way a commercial or marketing effort for the product(s) or technologies presented in this report.  As an unbised/impartial review, it supports the implementation of quantitative imaging as the key platform for reporting on the physiological effects as induced.



COMPREHENSIVE PERFORMANCE REPORT OF A TOPICAL SKIN CONDITIONING PRODUCT 

The  following is an anecdotal  performance  report  from a  single academic  case  study  to  represent  the effects of an exosome‐based topical product.  Process and reaction reports collected were from the durations of July 25‐August 21 under the strict medical supervision of IHRC/ Bard Diagnostic Imaging Center.  Quantitative imaging reports in this review were conducted strictly with the use of 3D Doppler Ultrasound imaging and Elastographic technology and are submitted by Dr. Robert L. Bard. 


TOPICAL SERUM EFFICACY PERFORMANCE – RESEARCHER’S LOG 

OVERVIEW:
Case study 1 of 1: the test subject is also a professional dermatologist who clinically identified disorders in the glabellar region (the smooth  part  of  the  forehead  above  and  between  the  eyebrows)  with  skin  roughness,  itchiness  and  pigmented protrusions.   Our research team established a base line with a sonogram scan labeled “DAY 1” at high resolution. The two short arrows point to the thickened epidermis, which is normally 200 microns and it is thickened to between 300 and 500 microns‐ as indicated by the arrows and the circle. Upon review, the tissue appears to be considerably swollen between the epidermis and the bone, and the inhomogeneous echo pattern is filled with dilated subdermal glands. The significance of this is that the surface of a skin lesion in inflammatory diseases is dependent upon  the  subsurface or subcutaneous pathology, which is often not visible with the naked eye.   

In this case, after 27 days of using the product three times a day, we noticed that the arrow at day 27 points to the 200 micron  epidermis  and  the  swelling  has  greatly  reduced,  and  the  internal  subcutaneous  echo  pattern  is  more homogeneous with fewer dilated glandular regions.   From the user’s perspective, the volunteer expressed significant satisfaction after one month of progress and is now continuing use of the product with a 2nd bottle. 

ABSTRACT: Stem cells, just like every other cell in the human body, release exosomes to communicate with each other. Exosomes are membrane-bound vesicles with a diameter of about 40–160 nm, which are released from cells by an endosomal pathway. In June of 2023, the IHRC research team was introduced to the Exosome-based skin conditioning products.  They promoted topical product lines marketed to the aesthetics community as a “rejuvenating serum for at-home daily use, combining nano-encapsulated stem cell growth factors, powerful peptides, and the highest quality skincare ingredients available to support skin health and rejuvenation”. The product was also described to offer faster recovery after skin procedures. 

Global interest in the advancement of Exosomes continues to raise significant interest in the research community to explore and confirm findings about this technology as has been raised since the advent of stem cell research (early 1980’s).  Dr. Robert Bard initiated this “test drive” employing an IMAGE-GUIDED approach to monitor, track and report his findings through the use of advanced ultrasound scanning modalities.

IMAGING TRANSDUCER/PROBE TECHNOLOGY & SCAN INTERPRETATION:  On day #1, we used a 33MHz ultra‐high resolution probe. On day #27, because the roughness and puffiness of the skin had reduced, we use a 20MHz probe. What's important is the dermis is clearly seen to have two layers; one is a dark gray layer which is represented by the single arrow that points to the epidermis.  Below that is a white layer‐  which is the  bottom layer  of  the epidermis. This is indicative  of a  collagen  disease  or inflammatory  disease  process and  the epidermis,  which  still  continues,  but  the  irregularity  in  the  epidermis  and  the  dilated  inflammatory  glands  have decreased dramatically. 

PART 2: A supplemental test is to expand this line of research to detect and measure the vascular effects of the inflammation with  the  3D  Doppler  histogram  technology.  This  ultrasound  feature  is  often  used  to  quantify  the  inflammatory vascularity. In this case study, we are able to detect intradermal hyperemia and inflammatory vascularity. 


STRATEGIC  TARGETING OF INFLAMMATION
Most inflammatory diseases are  subdermal  or  dermal and are not visually evident with the unaided eye. Use of the sonogram clearly shows measurable  epidermal thickening  and  irregularity.  Our  diagnostic  scanning indicated  subdermal  dilated glands  and  cystic  areas which  are  related  to  the  inflammatory  process.  While  quantitative  imaging helps  us  identify  the cosmetic  effects  of exosomes with this product, confirming  this  with  the patient’s reported reduction of  itching  (or  pruritus reduction) aligns with the product’s anti‐inflammatory effect.  This is a conceivable indicator of the depth of penetration of this product from the surface to the subcutaneous tissues, offering potential validation of the therapeutic effects of this product. 

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IMAGING MODEL USED IN THIS STUDY: THE CANON APLIO i800 (3D DOPPLER AND ELASTOGRAPHY)
For this research project, the research imaging director opted to advance the quantitative data gathering by employing the elastogram feature of the ultrasound system.  Dr. Bard's research sought the functionality of the CANON APLIO i800.  Thanks to Canon's expansive collection of transducers (probes), scanning the epidermal area was made possible in pursuit of physiological reactions to the patient's exposure to the topical exosome serum. 

PHYSICIAN'S NARRATIVE REPORT
By: Dr. Robert Bard
There are quite a few advantages to the multiple probes of the Canon Aplio i800 package, starting with the "hockey stick" probe at 22 MHz which provides focused small point resolution of a dermatologic target lesion. The fact that the probe has doppler as well is useful. The next probe in the system would be a 24 MHz pro, which has doppler imaging and elastography.  This will offer a broader view, but also show the high resolution microvascular flow in the system. Microvascular flow is different from Doppler because it shows the tiny low velocity vessels that are very important in inflammatory and malignant disease processes. Moverover, the system carries a 33MHz probe, which is essential for aesthetic use because plastic surgeons now need resolution from 500 microns. That's 0.5 millimeters to image the depth of five millimeters of dermal thickness, including the epidermal layers. The multiple functions in one readily available unit makes this device applicable for advanced, yet rapid image guided diagnostics with treatment applications based on the imaging findings.

The visual quality of the large high resolution screen was superb and  and offered a useful view to the technician and the patient who are observing the investigational use of this advanced device. The advantage of having a high resolution 33 MHz probe, which is priced competitively with the more expensive and higher resolutions, 70 MHz probes from other units make this a commercially viable office-based product. 

For complete information on the Canon Aplio i800 series, visit Canon's product site (LINK)



SPECIAL THANKS

IHRC and Health Tech Reporter wish to give special thanks to all the clinical technicians and volunteers who offered their time and support in completing this performance test study.  We also express our deep appreciation to the generosity and innovative brilliance of Dr. Jordan R. Plews, Co-founder & CEO of ELEVAI Labs, Inc. for his remarkable product(s), his clinical guidance and his scientific tour of the ELEVAI product development which greatly inspired the strategic planning behind this phase 1 study.  Further thanks to Mr. Michael Wetter, Ultrasound Regional Business Manager of Canon Medical Systems USA, Inc. for their professional support in the facilitation and use of their imaging technology and further education in ultrasound advancement. Additional thanks belong to Abdellatif Zerzif (ultrasound & laser tech) for his stellar professional performance in managing both technologies and patient care.  Major thanks belong to clinical and diagnostic talents of Dr. Robert Bard as well as reporters Lennard Gettz, Dr. Noelle Cutter, Dr. Roberta Kline and Dr. Leslie Valle-Montoya for their research structure and coordination throughout the execution of this project, including the development of this final report. 



FOR IMMEDIATE RELEASE

10/25 - Dr. Robert Bard's presentation has been approved for the Inflammatory Skin Disease Summit 2023 in Vienna from November 15-18, 2023. The conference will be accommodated at the Austrian Academy of Sciences (Aula der Wissenschaften).  This world conference welcomes experts in the medical community to discuss new concepts and new developments in the field of inflammatory skin diseases and to devise and explore new therapeutic strategies. The ISDS is promoted by the ESDR- European Society for Dermatological Research, an institute committed to the education and training of the next generation of skin researchers and to promote the highest quality skin research. The expertise that resides within the ESDR community is immense from skin research centers to individuals. 

2022 Events Courtesy of Bardvideos.com
Since the inception of his profound career in cancer research and advanced diagnostic imaging, Dr. Bard has been a staunch supporter of non-invasive imaging technologies that has proven to offer significant quantitative biometrics for a wide range of clinical uses. From pre and post-op scanning, clinical research validation and 2nd opinion scans, Dr. Bard's mission as a medical educator is to mobilize more effective strategies in pathology reporting and data gathering through the use of ultrasound functions.  He is globally recognized in conferences and throughout the medical media for his informative presentations and published textbooks on diagnostic imaging science- including his  highly referenced IMAGE GUIDED PROCEDURES series.

Dr. Bard's latest presentation to be delivered at the ISDS conference is the "ABSCOPAL EFFECTS OF IMAGE GUIDED PULSED BIOENERGY TREATMENT WITH VIRTUAL BIOPSY".  His report explores adjuvant treatment effects of modern and non-invasive therapeutic solutions such as pulsed near infrared laser and pulsed electromagnetic therapy irradiation (PEMF) and their potential in invoking an “abscopal effect,” which occurs when the primary site is irradiated, and regression of non-irradiated sites are observed. 

 ABOUT THE ESDR
The European Society for Dermatological Research (ESDR), founded in 1970, is a non-profit organization promoting basic and clinical science related to dermatology. The ESDR is the largest investigative dermatology society in Europe with a current membership of about 1100. By supporting investigative dermatology and skin research, the ESDR contributes to in-depth understanding of skin homeostasis and towards improving the health of patients suffering from skin and venereal disease, infectious diseases and immune-mediated and inflammatory disorders. Applications of recent scientific advances have produced diagnostic and therapeutic innovations in dermatological practice, particularly in genetics, skin cancer, allergic skin disease, infectious disease and autoimmune diseases.







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