Stem Cell Bra

FAQ

Stem Cell Bra’s FAQ

What is Stem Cell Bra and Stem Cell Bra Plus?
Stem Cell Bra is primarily based on bioelectric stem cell homing signals applied to breasts with a gel tape electrode which will comfortably fit in any bra (conforming shape adapting bras are recommended). The patented and patent pending bioelectric signaling sequences release SDF1 and PDGF proteins in breast tissue which serve to call like a homing signal a person’s own stem cells from bone marrow, fat tissue and circulating blood to migrate to breast tissue. Other signals which may be programmed into the Stem Cell Bra include those that control release of tropoelastin for improving elasticity and others for controlling proliferation (multiplication) of recruited stem cells and their differentiation into breast tissue. Additional bioelectric signaling sequences focus on improving blood circulation which in turn helps promote breast tissue growth especially when combined with stem cell recruitment and proliferation.

Stem Cell Bra Plus is the same as above but combined with fat grafting, stromal fraction and stem cell injections and a cocktail of support factors which may include any one of these; PRF, amnio fluid derived exosomes, selected growth factors, selected exosomes, oxygenated nano-particles, small amounts of hormones such as progesterone, micro RNA gel, nutrient hydrogel and breast tissue promoting extracellular matrix.

Is Stem Cell Bra FDA Approved?
No. The bioelectric stimulator that we program our bioelectric signaling sequences into does have FDA 510K market clearance as a Class II device only for improving blood circulation, mild pain relief and accelerated healing of muscle injuries. It is not market cleared or approved for breast tissue augmentation. Investigators and our company plan to gather data in carefully designed studies both outside of the USA and within the USA to support an filing with the FDA requesting to add breast augmentation as a cleared indication of use. As of December 31, 2018 this device has not yet been proven to be safe or effective or breast tissue augmentation and is available only for investigational use in properly designed and controlled studies with proper patient consent forms completed and appropriate regulatory clearances where applicable.

What evidence is available supporting Stem Cell Bra and Stem Cell Bra Plus may be proven to be safe and effective in the future through properly controlled studies?

Stem Cell Bra
Studies are team helped support with our advisors at Cleveland Clinic, the University of Florida and other institutions demonstrated that SDF1 and PDGF are proven to promote stem cell homing and migration.  
 
Our team published in Circulation in 1999 working with Dr. Shinichi Kanno a paper demonstrating the ability of precise bioelectric signaling sequences to not only improve blood circulation but also to regenerate tissues that were degenerating. 
 
Dozens of studies have been published documentation the safety and wound healing efficacy of microcurent.
 
As of December 31, 2018 our team has sponsored 15 large animal studies on applying stimulation to breast tissues with a focus on safety evaluation.  Histopathology and echo studies verified no adverse effects.  Breast volume increased by 20 to 30% and milk production when lactating increased. 
 
See our Related Scientific Articles page for these references – https://stemcellbra.com/supporting-articles/
Stem Cell Bra Plus
Fat grafting has been applied to thousands of patients to date for breast augmentation with dozens of case reports and studies reported. 
 
Our team completed our first stem cell repair of a major organ in 1988 working with Dr. Race Kao and George Magovern in Pittsburgh which was published in The Physiologist 1989.
 
Stromal fraction and stem cell breast augmentation has been documented in a number of studies.  Dr. Stuart Williams, Dr. Keith March and John Chi of our advisory team are pioneers in the development of products for extracting stromal fraction, endothelial progenitor cells and stem cells from fat tissue.  Dr. Stuart Williams was the original inventor of the kit to extract stromal fraction and cells from fat tissue back in the 1990s and has been part of more than a dozen related studies as has Dr. Keith March and John Chi.
 
Dr. Joel Aronowitiz of Cedars Sinai UCLA our Chief Medical Advisor was the first in the USA to complete a fat grafting and stem cell reconstruction of a breast lost to cancer.  He has been a part of numerous related studies since. 
 
See our Related Scientific Articles page for these references – https://stemcellbra.com/supporting-articles/
 
Warning:  Despite the early data from these studies mentioned above Stem Cell Bra and Stem Cell Bra Plus have still to been proven to be either safe or effective in statistically significant double blinded, randomized, placebo controlled studies. 
Is wearing the Stem Cell Bra painful or uncomfortable?
The 15 sheep and cows studied so far showed no signs of discomfort. Many of them fell asleep during the procedure. Our own lab members have applied the device their own breasts and report total comfort with only a very small faint pleasurable sensation felt.
When will the Stem Cell Bra be commercially available?
It is difficult to know how long the studies will take and how much data the FDA and other regulatory authorities will require before providing market clearance. It could be a number of years. In the meantime access is likely possible by entering a controlled clinical studies outside of the USA or in selected centers in the USA.
How long do I have to wear the Stem Cell Bra?
The large animal studies that demonstrated 20 to 30% breast tissue growth with no side effects had a stimulation time of 1 hour every other day for 4 weeks.
Will I be able to wear Stem Cell Bra at home?
At this time Stem Cell Bra may only be applied in approved clinics under the supervision of trained cliniciWe do anticipate that after statistically significant controlled clinical studies are completed in clinics a new study will be initiated to examine carefully the safety and efficacy of at home use. We do believe eventually this could be an at home use product but this will likely take a number of years of carefully implemented studies first. Stem Cell Bra Plus which includes fat grafting, stem cells and support factors will always only be available at hospitals and properly equipped clinics much like breast augmentation surgery today.