News

Got Stem Cells on the Brain?

As we’ve mentioned before, Burst Biologics has its own lab and a staff of Ph.Ds working to make contributions to science, but we also follow what’s going on in our industry as a whole. There have been some amazing developments in the fields of biology and regenerative medicine over the last few years, like this exciting new study released in Stem Cell Journal on July 11 about the use of neural stem cells in the brain.

We thought the study was so interesting that we wanted to pass it along to you! 

Moving Neural Stem Cells

Human neural stem cells

Picture a big brick building on the riverfront. You walk up to it and notice that one corner of the building has suffered some serious water damage, probably from a recent flood. To fix the problem, you’ll have to redo some of the masonry, and in order to do that, you need to get bricks to the construction site.

Unfortunately, moving bricks poses a bit of a challenge. Access to the site by land is restricted, and the water is flowing the wrong way for an easy trip by boat. As you ponder the situation, you quickly realize that it doesn’t matter how well-made your bricks are – they won’t do any good unless you can get them where they’re needed.

In the case of the study “Electrical Guidance of Human Stem Cells in the Rat Brain,” researchers were faced with a similar dilemma: how do you get viable neural stem cells to the part of the brain where they can actually be useful in repairing damaged brain tissue?

An Electric Idea

What these scientists found was that they could mobilize and guide neural stem cells in the brain in vivo through electric stimulation.

They transplanted human neural stem cells (hNSCs) into the rostral migration stream (RMS). This pathway is a mechanism in the brain unique to certain animals, including rodents, rabbits, and monkeys. (Humans have one too, but it’s nowhere near as substantial as in other mammals, particularly rats.)

Along this special migratory route, neurons can differentiate once they reach the olfactory bulb (OB). However, with the application of an electric field, transplanted cells migrated against the endogenous cues. In other words, instead of going toward the OB, these neural stem cells moved deeper into the brain.

Intermittent electrical current drives human neural stem cells

In the case of our brick building scenario, it would be like moving bricks to the construction site against a river current. You’d obviously need a special kind of boat to get there, and any effort would pose its own challenges. For example, if you used an electric-powered speedboat, you would have to confront the other unique difficulty in this case, which is working safely with electricity.

The reality is, you don’t want to introduce a direct current electric field to the brain. This would induce a dangerous, potentially brain-frying Joule effect – and we doubt these rats did anything to deserve the electric chair!

As an alternative, the researchers devised an intermittent electric field technique that minimized the detrimental effects and still managed to guide the migration of hNSCs and maintain cell viability. With this strategy in place, no animals suffered seizures or other obvious complications from the electric fields.

What Researchers Found

The ultimate results of the study were well worth noting. In looking at the rat brains at three weeks and again at four months after the electrical stimulation, researchers saw that NSCs had migrated from the injection site to the lateral ventricle (LV) region and the contralateral hemisphere of the brain, against intrinsic guidance mechanisms. What’s more, the effect of the electric stimulation continued to work even after the stimulation stopped!

Obviously, there’s a lot more to this study than we can delve into here, but the fundamental idea behind it is fascinating to consider. There may be profound implications for healing brain damage and reversing degenerative brain conditions in humans.

It also goes to show that there’s nothing more exciting than thinking up novel solutions to problems that have confounded scientists in the past, especially as new technology becomes available.

As our lab techs and researchers approach new challenges, these are the kinds of stories that inspire us – and we hope they inspire you too!


What is Regenerative Medicine Today?

Prometheus regenerating liver

We all remember Prometheus.

As you’ve probably heard us mention a time or two, Burst Biologics is in the business of regenerative medicine – and yes, it’s as cool as it sounds!

But what does regenerative medicine mean?

At its core, it’s all about helping human cells, tissues, and organs work properly. This branch of medicine focuses on the way cells live and function every day.

Compared to the whole of medicine, this is one field that’s quite new. However, forms of regenerative medicine have been practiced for more than 1000 years, and were acknowledged conceptually even in Ancient Greece. Remember Prometheus and his regenerating liver?

Of course, what we think of as regenerative medicine today is closely associated with the emergence of tissue engineering back in the late 1980s. It’s all based on the way cells work.  

The Magical Regenerating Cell

You have trillions of cells in your body, and they’re constantly regenerating. That’s the basic explanation for why you can donate blood, get a haircut, or heal from a broken bone.

Some types of cells replace themselves quickly, like the stomach cell’s two to nine day lifespan. Others last much longer, like the four month renewal rate for red blood cells.

But in any case, the concept of regenerative medicine hinges on this idea of regenerating cells.

Defining Regenerative Medicinecells can be replaced or regenerate

So, to better understand regenerative medicine, we need to consider what would happen if a group of cells in your body weren’t operating at their best. Conceptually, what could we do to fix that problem?

From the purview of regenerative medicine, it comes down to two general remedies.

 

Replacement

One clear solution is to replace the deficient cells or tissues with healthy ones. That’s essentially what an organ transplant is. If you have a failing kidney, swapping it out for a new one can rapidly restore functionality.

Replacement can be difficult, expensive, and invasive – but sometimes, it’s the only recourse available to patients with serious damage to their tissue or organs. With regenerative medicine, it’s possible to grow the new tissue that’s needed for replacement.

Regeneration

Another option is to regenerate the tissues and encourage self-healing. With this approach, you’re simply helping the body do what it normally could do, kind of like filling up the gas tank in a car that’s stalling.

One of our products is a fluid that aids and supports various mechanisms which encourage bone consolidation. Obviously, the body already knows how to heal bones, but this product aids in regulating the micro-environment to be one that encourages bone consolidation so that patients recover more quickly.

If you were to see what’s happening at a cellular level, you’d notice signaling molecules like growth factors and cytokines swooping onto the scene of an injury. These cytokines interact with cell receptors in local host cells, and can trigger a response indicative of wound healing. Basically, almost as if leading by example, these healthier cells demonstrate the way the host cells should be working, encouraging them to get back to their former, healthy selves.

Cells Themselves

The field of regenerative medicine relies heavily on advances in tissue engineering, and exemplifies plausible use cases for cellular and a-cellular allografts. But you’ve probably heard a good deal of talk about “stem cells”, and wonder how that plays a part. A good way to think of regenerative medicine is as if it’s a company, in a thriving economy. This one company is made up of different departments, and within those departments are different job descriptions and different individuals filling them.

The focus for regenerative medicine has been on “stem cells”, here at Burst Biologics we believe that’s not the best way to look at regenerative medicine. It’s so much more than that. Instead, try to think of stem cells as a single worker, in a single department, of a whole company. Yes, it does its part. Yes, it makes the whole team complete. But the rest of the team isn’t relying on the existence of that one worker to do their own jobs. 

The Future of Regenerative Medicine

The potential applications of regenerative medicine are truly profound. With tissue engineering and regenerative medicine products, physicians have the building blocks they need to change, repair, and grow damaged tissue in patients.

Previously impossible treatments are theoretically possible using regenerative medicine, reversing the effects of aging, organ failure, chronic wounds, and lifestyle diseases. The future of regenerative medicine – and the medical field as a whole – has never been brighter!

 

 


Burst Biologics: Making Wishes Come True

Wishes being granted

7-year-old cancer patient uses Make-A-Wish to help others

Here at Burst Biologics we care about people; we recruit the best in the field, we develop the most innovative solutions,
and we celebrate a strong company culture. Right now, we’re the most excited to celebrate making wishes come true for kids across the country. Wishes are for more than toddlers and storybooks, the Make-A-Wish Foundation says themselves, “A wish experience can be a game-changer for a child with a life-threatening medical condition.” In fact, they believe in the power of wishes so much, they know that “wishes are more than just a nice thing, and they are far more than gifts or singular events in time. Wishes impact everyone involved – wish kids, volunteers, donors, sponsors, medical professionals and communities.”

Who wouldn’t want to be a part of that?

The minute Make-A-Wish Idaho announced their annual Walk for Wishes fundraiser, we knew we were in!

Here are three reasons why you should be “in” with us:

1. It’s good for you! Not just the warm, fuzzy feeling you’ll get from helping children across the country have their dreams come true, but because you’ll get to go on a walk. According to the Mayo Clinic regular walking can improve your bone health, your mood, and provide all sorts of other health benefits like helping your heart, weight maintenance, and even blood pressure.

2. Connect with us. Members of the Burst Biologics team are going to be at this walk, and we want to meet you! Let’s hang out, get some fresh air, and probably take a selfie or two.

3. You’ll win cool stuff. You heard that right. We want to make such a huge impact on this fundraiser that we’re ready to give you prizes for joining our team and donating with us. Here’s what we’re offering:

    • $100 – Once you donate or raise $100 we’re going to send you a personal social media shoutout. We want to promote you; and help children. You want to help children, and have us promote you – it’s a win-win.

 

    • $500 – Get included on our shirts. The Burst Biologics team is going to be sporting some amazing shirts at the walk, and we would love to include your company name and / or logo on them. (Donations have to be received by May 12th to ensure time to make the shirts.

 

    • $1,000 – You thought the social shout-out was good? Well if you step up your fundraising game we’ll include you in our blog post recap about the event; complete with photos of our team in the walk (and probably a few cute dogs), and a link to your website as we brag about how great you, and your company, are.

 

  • $5,000 – If you raise this much, you are officially a fundraising guru. Which means you’re probably interested in chatting with somebody on par with your fundraising skills, like our CEO Chris Jones. We’d like to set you up with that chat, and Chris himself will take you out to dinner or for a round of golf. You can talk fundraising, tips on running a business, or even golf (Chris has a mean short game) – the possibilities are endless.

 

So let’s start racking up some cash for a cause, cultivate some warm-fuzzies by doing something good, and win some prizes. We’ll see you there.

Click here to join the Burst Biologics Make-A-Wish Idaho team, and start donating and / or fundraising today!


BioBurst Fluid: Latest Clinical Study Underway

BioBurst Fluid and Microscope

Exciting news for Burst Biologics as we’ve secured approval for our latest clinical study focusing on challenging foot and ankle surgery patients using BioBurst Fluid. This particular clinical study framework was created widely in order to evaluate complex surgeries in challenging patient populations.

Most people will suffer from some degree of foot or ankle problems during their lifetime. Many times, those who are in need of surgery have endured long periods of debilitating pain and disability.  Because the foot and ankle have to bear the weight of the entire body, bone grafts used for arthrodesis or correction must heal quickly and completely. We believe this registry will demonstrate BioBurst Fluid’s ability to jump start the vascular process needed in bone formation.

We had the pleasure of sitting down with Dr. Burk, (foot and ankle surgeon)  to speak on behalf of BioBurst Fluid. Dr. Burk stated, “Complex procedures where surgical intervention is needed, often requires a jumpstart to facilitate the bone formation process needed to heal. Products like BioBurst Fluid give physicians like me a sophisticated and much-needed tool to address these patients.”

 

 

 

 

 

 

 

 

 

 

 

 

 

View this story on Newswire by clicking here.

To find out more on this prospective multicenter clinical study please visit: https://clinicaltrials.gov

Want more? Check out our last blog post.


BioBurst Fluid: extensive spinal fusion clinical study

 

Burst Biologics is excited to begin the IRB approved multicenter prospective clinical study in spinal fusion patients. BioBurst Fluid, a cellular umbilical cord blood (UCB) derived allograft, has shown very promising results in spinal fusion procedures. Aimed at documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes, this study will include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on surgeon and patient-based outcome assessments.

At Burst Biologics, we believe that creating clinical portfolios is essential to supporting physicians in making informed decisions. Because of this, we feel this clinical study will allow us to set a higher standard in the cellular allograft arena.

Steve Czop, Medical Affairs Officer at Burst Biologics: “Over the past five years working in Medical and Clinical Affairs, I have had the opportunity to meet with key Medical Directors throughout the country representing large regional hospital systems in order to display the clinical portfolio of several new products or technologies. The takeaway from those meetings was that a new product or technology must be successful in the “real world.”  Patient registries achieve this by gathering outcome data from a wide segment of patients that would otherwise be excluded from more formal controlled studies. As such, they more accurately describe results seen in a typical physician practice setting or large hospital system. Registry outcomes, along with specifically targeted key clinical studies and compelling basic science research will demonstrate the clinical utility, success, and cost-effectiveness of Burst Biologics products in the new paradigm of evidence-based medicine.”

The increasing popularity of cellular allografts over the last decade creates exponential opportunity for our products. Our research and development team strives for success in all areas.

Dr. Trillitye Paullin, Ph.D., Molecular Biologist at Burst Biologics:  “At Burst Biologics Department of Research, our team of scientists are working towards fully understanding the mechanisms responsible for BioBurst Fluids’ clinical response.  Utilizing highly technical procedures, we can create a complete analysis of why patients are experiencing positive spinal fusion outcomes.  Burst Biologics is setting the industry standard through its research and forthcoming scientific publications.”

 

View this story on Business Wire: Burst Biologics Initiates Prospective Multicenter Clinical Study

To find out more on this prospective multicenter clinical study please visit: https://clinicaltrials.gov

Want to see what else is new at Burst Biologics? Catch the latest by clicking here.

 


Dr. Gershon: Success Using Regenerative Medicine


Burst Biologics – Dr. Julian Gershon Success Using Regenerative Medicine

REGENERATIVE MEDICINE AND BIOBURST REJUV

Owner of the Aspen Institute, Dr. Julian Gershon, sat down and spoke with us about his involvement in the field of regenerative medicine and the benefit of our products at his practice. After finding personal success using BioBurst products, Dr. Gershon made it his goal to share his findings with patients.

Within the past year, Dr. Gershon has seen tremendous results using our product, BioBurst Rejuv. Beyond current use and applications, Dr. Gershon is especially excited for a future in exploring new applications of our product. “Really, I’m excited about using the BioBurst product with more patients.” After touring the facilities, Dr. Gershon sees the depth of knowledge and understanding with regard to how our products work at a cellular level. “I think we will see the BioBurst products used generally throughout medicine in the future, not just for orthopedic injuries.”

It was evident in our interview that Dr. Gershon is passionate about his practice, patients, and confident that cellular allografts are an extremely powerful source of regenerative medicine. ” I love sharing and making a difference in patients’ lives using this product.”

Want more? Check out our last blog here. Stay tuned for future blogs featuring the latest at Burst Biologics.

 


Scientific Discovery: The future for gene editing

In Radiolabs podcast, “Antibodies Part 1: CRISPR”  scientists talk about the hidden gem inside some of the world’s smallest organisms. CRISPR could possibly be one of the most powerful tools scientists have ever stumbled across. The excitement rises over this scientific discovery as it explores the future for gene editing and the potential to rewrite the way we change DNA.

Why is this so important? Gene editing may be the key to preventing things such as cancer and other life threatening diseases.

For the first time, there is a possibility for a gene editing technology that can be cheap, precise, and possibly universal.

As of this year, Jennifer Doudna and Emmanuelle Charpentier were awarded the Japan Prize for their invention of the revolutionary gene-editing technology known as CRISPR-Cas9 which has swept into research labs around the world. CRISPR-Cas9 is already yielding new therapies for cancer and hereditary diseases.

Check out the podcast by clicking play below or heading over to radiolab.

 

GUESTS:
Jennifer Doudna, Eugene V. Koonin, Beth Shapiro and Carl Zimmer

CHECK OUT MORE FROM RADIOLAB:

Radiolab Podcast Articles

Burst Biologics: In Medical Affairs Experience Matters

Expressing his eagerness to expand into the growing area of stem cell research and regenerative medicine, Steve Czop gives us a look into his current position as Medical Affairs Officer at Burst Biologics. Having studied pharmacy for ten years, Steve believes that our culture of excellence at Burst Biologics is what ultimately drew him here.

Steve spoke of current projects, the foundation Burst Biologics is laying, and what has been the most impactful for him thus far. It was apparent by the end of the interview that Steve will play an essential role in the success of our company.

Steve Czop, Medical Affairs Officer

 

 

 

 

 

 

 

 

 

Where are you from?

Steve – I grew up in New Jersey but just recently moved to Tampa, Florida to get away from the cold weather.

What is your educational background?

Steve – I have a B.S in Pharmacy from Rutgers College of Pharmacy. I was a practicing registered pharmacist for about 10 years and then decided to go in a different direction.

What is your past work experience before starting your role at Burst Biologics?

Steve —  I learned most of everything I do now through my work at several different companies. I started out with a company called EBI, which was part of Biomet at the time. My career at Biomet lasted 13 years, and during that time I started out at the bottom as a clinical research assistant and worked my way up to senior clinical research associate. I took on regulatory responsibilities while learning about medical writing. I obtained my regulatory submissions experience during the down times in clinical research functions.

I, then, moved to Redmond, Washington, where I joined a start-up company. The excitement it brought me to bring new technology onto the market was something I couldn’t pass up. At this company we developed a facet joint replacement, obtained IDE approval fairly quickly, and initiated a multicenter clinical trial. Unfortunately, the economy downturned, the field of motion preservation shifted a bit, and the company failed, despite the work of a lot of dedicated and talented people. However, it was a great experience for me and a good opportunity to learn and grow.

Immediately after Redmond I moved back to New Jersey to work for my second startup ApaTech. ApaTech was a fabricator of a synthetic bone graft, Actifuse, that had some uncommon properties that were very unique. My job at ApaTech was to establish a clinical portfolio as well as fulfill a range of regulatory functions. We had 5 peer review papers in the time I was there. When the company was sold to Baxter, I continued there from 2010 to 2016. I worked with the ApaTech product in addition to supporting other products in their portfolio as a Senior Manager in Medical Affairs.

With your past experience and clinical research responsibilities, do you feel this fits in well with your new role at Burst Biologics?

Steve – I think I’m going to successfully fulfill a variety of different functions here at Burst Biologics. I have already started building a clinical portfolio for the company. As good as a science story is, you have to have actual clinical data to back that up. We’ve already initiated a patient registry where we’ll collect specific data on spine cases, cervical, lumbar, and foot and ankle surgery.

Taking on my regulatory duties, we’re going to develop and seek 510k clearance for a synthetic bone graft, which will complement the amazing products we already have available.

As the medical affairs officer I will evolve into a function where scientific questions, particularly those that can’t be addressed directly by the sales representatives, will be handled by me. I’ll also help our medical director handle adverse event evaluations.

What is your role in the current research projects at Burst Biologics?

Steve – My role right now is actually with the patient registry. I’ve written the protocols and designed the case report forms, or at least the structure and information required, while our IT and Marketing team will make the data entry interface very user friendly. The methodology and structure of the registry is something I had to consider very carefully to balance the need for quality data with the constraints of each surgeon investigator’s time and effort. We’re also going to do investigator-led studies, so that will entail me working with the CEO and listening to physician’s ideas for research. We will evaluate them and see if they fit in with what our core vision is, and if so, we would then provide a grant to the physician to carry on the work.

Based on other positions you’ve held, would you say there is a strong foundation here for success, particularly on the science aspect of it?

Steve – In my previous positions I’ve heard about cellular allografts and I know there is a tremendous interest in it. I’m very excited to be with a company that is on the forefront of this technology. There is a very keen interest in research and science here, as well as an incredible amount of attention paid to quality and quality control. In my experience, this is going to go a long way towards the company’s success. There is a constant push towards excellence, which is something that really attracted me to Burst Biologics. We are building a culture of excellence in the people we hire, the equipment we buy, the products we produce and the physicians we chose to work with.

With other companies that you’ve worked with, what would you say the percentage of outsource manufacturing was versus in-house manufacturing?

Steve – I have been in the industry for 26 years and have seen companies build in-house manufacturing then close and outsource them to reduce costs.  Based on my experience I believe that having manufacturing facilities in house gives you a greater degree of control over the quality and consistency of the product.

Burst Biologics differs from other laboratories in that we have an onsite laboratory and PhD’s that work and interact with executive staff on a daily basis, how do we stand apart from other companies in the industry?

Steve – I’ve been in companies that have some research staff in-house, but the fact that we have research staff that is involved in basic research to advance the science of the products we’re developing is incredible. Very few companies this size have research staff, and I think that the trend in other industries is to outsource that sort of thing while we’re doing it right here at Burst Biologics.

In your experience working with the company, what has been the most impactful so far?

Steve – I think the most impactful thing to me is just seeing the attention paid to the production of individual products, the quality control, the thirst for knowledge, and ways to improve the product while still maintaining a strong focus on education, science and research. It’s an incredibly diverse and dedicated culture here, which will serve us well going into the future.

To learn more about us and our premier cellular allograft products head to www.burstbiologics.com or contact us for more information.