What is the CerebraCell brain regeneration protocol?
CerebraCell is designed to recover lost brain function from stroke, injury or disease with non-invasive bioelectric stimulation. Our first product is expected to be a “brain saving helmet”, followed possibly by other advanced and possibly invasive therapeutic intervention. Future products may include directing a combination pacing (electrical conduction) lead and infusion catheter connected to a micro infusion pump to the affected brain areas and/or the implantation of a single or multiple micro bioelectric stimulation coils. For these severe cases the micro infusion pump would be designed to be re-filled daily, weekly or monthly with our proprietary CC-15 fifteen component mixed brain regeneration composition comprised of stem cells, growth factors, exosomes, Micro RNAs, selected alkaloids such as harmine, nutrient hydrogel and brain matrix which is slowly and repeatedly infused into the affected brain regions.
What are the mechanisms of action of the CerebraCell therapy?
Summary – We strive to regenerate damaged brain tissue and to improve blood circulation. Are product is intended to:
- Stem cell homing from precise bioelectric signals- SDF1 + PDGF. A person’s own stem cells are recruited from their bone marrow, fat tissue and circulatory blood.
- Stem cell proliferation from precise bioelectric signals.
- Stem cell differentiation control from precise bioelectric signals.
- New blood vessel formation from precise bioelectric signals – VEGF, PDGF, eNOS, HGF, HIF1a, SDF1.
- Improved elasticity of tissues from precise bioelectric signal – Tropoelastin.
- DNA repair from precise bioelectric signal – IGF1.
- Inflammation real time monitoring and real time treatment via InStim bioelectric inflammation management bioelectric signaling.
- Brain regeneration from repeat infusions or injections of stem cell based cocktail composition with exosomes, Micro RNAs, selected alkaloids such as harmine, nutrient hydrogel and brain matrix. The infusions/injections will include not only stem cells but also SDF1, PDGF, HGF, IGF-1, Tropoelastin, Harmine, GDF-10 and GDF-11.
How does CerebraCell plan to assess the brain to know where and when to deliver the therapy and if the therapy is working?
CerebraCell has partnered with leading visionaries in EEG and other brain imaging modalities to develop a portable system to objectively assess, treat, and monitor the patient’s brain activity in near real-time. Our current prototype employs the use of dry EEG sensors, a technology that has been shown to reveal structural and functional abnormalities in the brain, thus making it ideal to detect trauma in both the acute and chronic phase of injury. In addition to EEG, we are exploring potential integrated systems with two modalities that may extend the use of our current CerebraCell system into more severe forms of brain trauma and age-related disorders.
To precisely map areas in the brain that need treatment, we utilize next-generation analytics that measure the flow and magnitude of neural current throughout the brain. This allows precise, near real-time monitoring and the ability to deliver and track treatment with mobile technology. With the use of advanced machine learning classifiers, we are developing analytics that will better inform the provider of the patient’s current brain condition, the effectiveness of the treatment, and objective data delivered to the medical team in near real-time.
Currently, we are partnered with academic and industry leaders to conduct research across the entire spectrum of Traumatic Brain Injury, mild to severe. To prepare analytics for our mild cases (called mTBI or concussion), we will have access to sports-related concussion data and clinical data from patients that have been assessed for post-concussion syndrome. In addition, we are partnered with two leading universities to conduct research with severe, acute cases.
What scientific evidence is there that this will work?
The CerebraCell team is just now embarking on translational research studies to demonstrate the safety and efficacy of our combined modality treatment protocol. This is an exciting area of research with to date little/no data supporting any performance claims on this combination.
Separately, component-by-component, the Leonhardt team has studied the safety and efficacy of the various cells, growth factors, genes or bioelectric stimulation for organ regeneration applications since the early 1980’s. Other independent researchers have published on organ recovery potential of nearly all components of the CerebraCell comprehensive combined therapy. In 1989 the Leonhardt team – working with Dr. Race Kao – published the first paper on stem cell repair of a major organ in large animals in The Physiologist. This pioneering early work lead to Pilot, Phase I, Phase II and Phase II/III double blinded randomized placebo controlled clinical studies for heart regeneration at over 33 leading sites in the USA and a half dozen in Europe led and sponsored by the Leonhardt team. In 1999 working with Dr. Shinichi Kanno the Leonhardt team published in CIRCULATION the Journal of the American Heart Association the first paper documenting organ regeneration with precise bioelectric signaling designed to control specific protein releases (VEGF) to improve blood flow. The study confirmed a 230% increase in blood flow in the patient studied. This led to a number of other pre-clinical and clinical studies for limb salvage conducted by researchers collaborating with the Leonhardt team.
The area of organ regeneration and healing using electrical stimulation and/or stem cells is well documented. Over 100 publications around the world document the healing properties of controlled electrical stimulation. Over 1000 peer-reviewed published papers document the potential healing effects of stem cells. Over 100 published papers document the potential therapeutic benefit of growth factors and genes in healing organs. Over a dozen papers document the possible benefits of injectable hyrdrogel and matrix injections. Over a dozen papers document the potential healing benefits of injections of selected exosomes and Micro RNAs. A selection of the best of all these published studies may be found in the Related Scientific Articles section of this web site. Of particular interest are papers from Stanford documenting incredible recovery from brain stroke in patients treated with modified stem cells and a UCLA paper on the powerful brain regeneration properties of GDF-10 both of which we plan to include in our multiple modality protocol. There are also many papers documenting the brain regeneration potential of IGF-1, SDF-1, PDGF, HIF1a and harmine all of which we have included into our therapeutic regime.
How do we get the therapeutic bioelectric signals and regeneration composition to the target brain area?
- Our preferred method is via frequency controlled electro-magnetic pulsed energy waves sent from our “brain saving helmet” that cross at precise chosen deep brain locations intended to create a controlled energy envelope which in turn controls precisely local protein expressions such as SDF-1 and PDGF for stem cell homing and HIF1a, eNOS, VEGF and PDGF in combination for new blood vessel growth.
- Our second method (to be developed only if a non-invasive approach is found ineffective) is to design an implant consisting of electrical conduction (pacing) lead catheters with an infusion lumen to the target brain treatment regions. This component would be designed to be connected to an implantable or external micro bioelectric stimulator and micro re-fillable micro infusion pumps.
- Our third approach to recover lost brain function is to create an implant consisting of a series of micro-size coil implants, about the size of a flea, in all the brain regions targeted for therapy. These implants would be designed to communicate with our “brain saving helmet” to both read and monitor the brain activity as well as be activated to control local release of brain regeneration promoting proteins.