FAQ’s

What is EyeCell and EyeCell Plus?
The EyeCell proprietary protocol is a series of bioelectric signaling sequences designed to restore vision loss. The bioelectric signals control the release of these regenerative proteins designed for these purposes…

1. SDF-1 and PDGF = stem cell homing.
2. IGF1 = DNA repair.
3. VEGF, PDGF, SDF1, HIF1a, CXCL5, HGF, EGF, eNOS = growing new mature blood vessels

EyeCell Plus meant for treating the most severe vision loss cases only is the same as above with up to 13 additional bioelectric signaling sequences added with the further addition of a re-fillable micro infusion pump that is used to very slowly infusion regeneration promoting cells and growth factors into the eye carefully under control. The EC-15 composition intended for eye regeneration is comprised of adipose tissue derived stem cells, selected exosomes, selected growth factors, PRF, amniotic fluid, stromal fraction, micro RNA gel, selected alkaloids, oxygenated nanoparticles and eye matrix.

Is EyeCell FDA Approved?
No not for eye vision recovery. The bioelectric stimulator we program with our bioelectric signaling sequences is a Class II Medical Device sourced from Mettler Electronics in Anaheim, California that has U.S. 510K market clearance for improving blood circulation but not specifically for eye vision recovery. Improving blood circulation especially converting leaky vessels to mature non-leaky vessels is one of the intended purposes of the current eye vision recovery studies in process and upcoming.
What data is available to support that bioelectrics or microcurrent work for vision recovery?
Warning caution:  Conclusive data from proper Phase II/II double blinded, randomized, placebo controlled studies of statistical significance under the supervision of Institutional Review Boards, Data Safety Monitoring Committees and Regulatory Authorities have not been completed yet so now definitive performance OR safety claims can be made at this time.  Data shared herein from pre-clinical or small pilot clinical studies is not meant to make claims of safety or efficacy being proven.  Further warning of important PLEASE READ in some stem cell studies conducted by other organizations  patients may have been blinded from the procedure intended to help them. 
 
Here is a link to a collection of supporting pre-clinical studies for our bioelectric stimulated protein expressions, stem cells, growth factors, microcurrent and other components being considered for our EyeCell therapies https://eye-cell.com/related-articles/
 
. 2015; 9: 2345–2353. 
Published online 2015 Dec 17. doi: 10.2147/OPTH.S92296
PMCID: PMC4689270
PMID: 26719667

Microcurrent stimulation in the treatment of dry and wet macular degeneration

Laurie Chaikin,1 Kellen Kashiwa,2 Michael Bennet,2 George Papastergiou,3 and  Walter Gregory4
Author information Copyright and License information Disclaimer
Correspondence: Laurie Chaikin, Private practice, 420 F Cola Ballena Alameda, CA 94501, USA, Tel +1 510 693 8053, Fax +1 510 995 8376, Email moc.liamg@nikiahc.eirual

Abstract

Purpose

To determine the safety and efficacy of the application of transcutaneous (transpalpebral) microcurrent stimulation to slow progression of dry and wet macular degeneration or improve vision in dry and wet macular degeneration.

Methods

Seventeen patients aged between 67 and 95 years with an average age of 83 years were selected to participate in the study over a period of 3 months in two eye care centers. There were 25 eyes with dry age-related macular degeneration (DAMD) and six eyes with wet age-related macular degeneration (WAMD). Frequency-specific microcurrent stimulation was applied in a transpalpebral manner, using two programmable dual channel microcurrent units delivering pulsed microcurrent at 150 µA for 35 minutes once a week. The frequency pairs selected were based on targeting tissues, which are typically affected by the disease combined with frequencies that target disease processes. Early Treatment Diabetic Retinopathy Study or Snellen visual acuity (VA) was measured before and after each treatment session. All treatment was administered in a clinical setting.

Results

Significant increases were seen in VA in DAMD (P=0.012, Wilcoxon one-sample test), but in WAMD, improvements did not reach statistical significance (P=0.059). In DAMD eyes, twice as many patients showed increase in VA (52%) compared to those showing deterioration (26%), with improvements being often sizeable, whereas deteriorations were usually very slight. In WAMD eyes, five of six (83%) patients showed an increase and none showed deterioration.

Conclusion

The substantial changes observed over this period, combined with continued improvement for patients who continued treatment once a month, are encouraging for future studies. The changes observed indicate the potential efficacy of microcurrent to delay degeneration and possibly improve age-related macular degeneration, both wet and dry. However, this study has no control arm, so results should be treated with caution. Randomized double-blind controlled studies are needed to determine long-term effects.
What is the EyeCell Study Plan?
At our Utah laboratories we have conducted multiple rounds of laboratory (cells in a dish) and fresh cadaver eye studies (eyes obtained from Utah Lions Eye Bank) confirming our ability control desired protein expressions on demands. We plan now to move forward with pre-clincial and after sufficient safety data has been gathered onto clinical studies for our specific internally developed precise therapeutic protocols for both EyeCell and eventually EyeCell Plus.

In the meantime we have reached out to other research teams that have already completed pre-clinical studies and in some cases clinical studies in these therapeutics focus areas and have offered to join forces with them in further improving the therapies forward.

1. Microcurrent therapy.
2. Bioelectric therapy.
3. Stem cell therapy.
4. Micro infusion pump therapy.
5. Pulsed electro magnetic fields therapy.
6. Exosomes therapy.
7. Proteins therapy.
9. Micro RNA gel therapy.
10. PRF or PRP therapy.
11. Amniotic fluid or exosomes or stem cells derived from amniotic fluid therapy.
12. Placenta therapy.
13. Oxygenated nanoparticle therapy.
14. Matrix and hydrogel therapies.