Ajan Reginald: The regenerative medicine entrepreneur treating heart disease with stem cells

Cardiovascular disease (CVD),  in all of its forms, is the number one killer in the UK, Europe and the US. More often than not, it has long-term effects, including an enlarged, damaged and less efficient heart muscle which naturally leads to other disabilities and a notably decreased quality of life.

While the affected person certainly bears the burden of such diseases, society as a whole does as well. In a 2006 study, researchers found that CVD cost the UK economy £29.1 billion in 2004, with healthcare costs accounting for 60% of the total. This number is even higher in the US, with healthcare costs associated with CVD just under $300 billion per year.

It’s worth mentioning that CVD encompasses all diseases and conditions that affect the heart or blood vessels. But the focus here is on coronary heart disease, which often results in heart attacks and heart failure.

Read the full story at:

http://www.celixir-plc.co.uk/2020/05/29/ajan-reginald-the-regenerative-medicine-entrepreneur-treating-heart-disease-with-stem-cells/

Celixir and tendon regeneration therapy

What do you do if you have suffered a severe tendon injury such as tennis elbow? What are your options for recovery? Well, at present they are limited and typically only treat the symptoms of the damage or irritation caused by the affected tendon, they don’t enable regeneration of the tendon. 

Normally tendons require weeks of rest in order to begin the healing process, and in 80% of cases the tennis elbow injury will settle down on its own accord, treatment is a combination of rest, NSAIDs and physiotherapy. 

But for those patients suffering with chronic grade 3 lateral epicondylitis (tennis elbow) tendon injuries, the healing process can involve steroidal and non-steroidal injections and surgery, and in severe cases, healing may never occur. 

The overuse of tendons in the forearm from repetitive movements (such as using a computer, lifting heavy objects or repetitive vibrations, for example) can put so much strain on the tendons in the elbow near the attachment on the humerus, that it begins a degenerative process, from which there has been no recovery.

Current treatment options for tennis elbow 

 

  • Rest – rest is recommended to help relieve pain and control inflaming the area further. 
  • NSAIDS – NSAIDS can be prescribed to reduce inflammation and combined with the application of ice onto the affected site, can work in tandem to decrease inflammation and reduce swelling. These typically offer short term pain relief (3-4 weeks). 
  • Physical therapy – there are many different types of physical therapy that can be beneficial to treating tennis elbow, and they all have the same aim – to reduce pain and improve function in the affected area. 
  • Brace – the wearing of an elbow counter force brace for some patients can prove beneficial as it mimics the role of a secondary muscle attachment site, helping to relieve tension on the affected tendon. 
  • Corticosteroid injections – these injections should be given early to maximise their beneficial effect, typically during the first 24-48 hours. Following that they should be repeated after a couple of weeks rest, but they should not be given more than two times. These typically offer short term pain relief (6 weeks)  
  • Surgical treatment – usually the last option to treat epicondylitis lateralis if all other non-invasive therapies have proved ineffective. Surgical procedures for treating tennis elbow typically involve removing any diseased muscle and reattaching the healthy, remaining muscle, back on to the bone. This surgery is usually open surgery, performed in an outpatient surgery, and involves making an incision over the elbow joint. 

 

 

And now there’s Tendoncel, Celixir’s second major product following on from the creation of Heartcel, a myocardial regeneration therapy. 

Tendoncel

Tendoncel is a late stage allogeneic regenerative medicine, meaning it is designed to be ‘off the shelf’. This investigational topical gel has been shown capable of regenerating injured tendons near to the surface of the skin. 

Following positive results from a Phase 2 testing trial, it could provide the safe and efficacious topical regenerative therapy that patients suffering with tennis elbow have been looking for. A Phase 3 trial is currently underway, following on from the successful European Phase 2 trial.

How does Tendoncel work?

Tendoncel is an investigational topical gel containing platelet lysate, which can be applied directly to the site of the injury i.e. the skin on the elbow. It contains a combination of growth factors including a substance which promotes regrowth of cells, enabling the tendon to repair and heal itself. 

The Tendoncel Phase 2 clinical trial in patients with severe tennis elbow (chronic grade 3 lateral epicondylitis) showed significant improvements in their elbow pain, and if licensed in the UK could be a non-invasive treatment that negates the need for surgery. 

 

How to Pursue a Career in Regenerative Medicine

If you were to take a look at the educational and professional backgrounds of those apart of Celixir’s leadership – including its founders, board of directors and scientific advisory committee – you might be surprised by the variety you’d find.

Professor Sir Martin Evans, Celixir’s President, Chief Scientific Officer and co-founder, attended Christ’s College (a constituent college of the University of Cambridge) where he studied zoology, botany, chemistry and biochemistry. After graduating with a BA, he moved to University College London where he worked as a research assistant and graduated with a PhD. Not only did Sir Martin Evans isolate the first embryonic stem cells, he’s also published over 120 scientific papers and is the recipient of a Nobel Prize.

This, compared with Celixir’s Chief Executive Officer and other co-founder, Ajan Reginald, whose background is in both science and business. Ajan holds four degrees and is an alumni of Harvard Business School, University of Oxford, Kellogg Business School and University of London. After serving as the Global Head of Emerging Technologies for Roche Group Research, he moved on to the Business Development Director at Roche Pharma. Since, he’s helped develop Celixir’s breakthrough technologies including Heartcel and Tendoncel.

Of course, this is all to say that the path towards a career in regenerative medicine is not necessarily a linear one.

The Field is Growing

While – compared to other fields – regenerative medicine is in its infancy, technological advances, ever-increasing funding and high demand have made it grow quickly.

What’s especially exciting, though, isn’t that regenerative medicine is a growing market. Instead, it’s the virtually limitless possibilities in terms of what scientists and researchers can achieve with their work. As the world’s population ages and diseases like Alzheimer’s and Parkinson’s remain untreatable, more and more people are looking towards this multidisciplinary field for answers to a number of medical questions.

Desired Interests, Skills and Expertise

Regenerative medicine attracts people across several different fields including engineering, business, molecular science, healthcare and even robotics. And, because regenerative medicine is focused so heavily on applying current (and creating future) technology to improve quality of life for patients, it’s an especially attractive field for those interested in actually making a difference.

Ajan Reginald CelixirLuckily, and as demonstrated by Ajan Reginald‘s and Sir Martin Evans Celixir backgrounds, the skills learned in all of the fields mentioned above (engineering, business, molecular science, healthcare, robotics) can be applied to regenerative medicine. This is to say that functional expertise and not necessarily general knowledge about regenerative medicine is key. Imaging specialists, immunologists, bioengineers and transplant surgeons are all contributing to the advances being made, even if they don’t consider themselves specialists in regenerative medicine.

But, there are specific programs available at universities all over the world that act as a ‘direct’ gateway to regenerative medicine. That is to say that they focus on a specific segment of regenerative medicine, like tissue engineering.

Breaking Into the Industry

As mentioned, there is no linear path to break into regenerative medicine. But, there are a number of resources that can help.

If you’re a student, professors or other mentors within your university could provide networking opportunities. Alternatively, you could network at jobs fairs or other conferences like International Society for Stem Cell Research or World Congress on Regenerative Medicine. You can also apply to companies or universities directly.

Bear in mind that a career in regenerative can take a number of forms, from a research associate to lecturer to a project manager.

If you’re interested in stem cell research and regenerative medicine, keep up with the latest news on Celixir’s blog or follow Celixir on Twitter or Facebook.

The Potential Impact of AI on Cell Therapy

Just under two years ago, Ajan Reginald, the founder, CEO and thought leader behind Celixir, sat down with IntelligentHQ.com to talk about current challenges and opportunities within the healthcare industry. While Celixir’s own Heartcel was of course discussed as a cutting edge innovation in life-saving, life-altering medicine, artificial intelligence (AI) and its role in healthcare was also debated.

Ajan reginald celixirAt the time of this 40-minute interview, Ajan Reginald was especially excited about AI in that robots could potentially edit genes and inject cells with more precision than humans. For Ajan, breakthroughs in medicine come from increased patient benefit and he certainly saw the many benefits automation would offer. When you consider that the third leading cause of patient death is hospital error, it’s hard to disagree.

But, despite the obvious benefits, there were still a number of hurdles that had to be overcome, specifically in terms of data privacy and encryption. Scientists and researchers would have to work hard to develop technology that would ensure that the right patient got the right medicine in the right dose at the right time.

The question is, have the necessary advancements been made over the last 21 months?

On Our Way to AI-Dependent Healthcare

While healthcare providers and tech companies have been investing billions into testing AI-powered tools, the scientific and medical communities are still struggling to find solutions to data and privacy concerns. But, that doesn’t mean there haven’t been significant advancements with massive potential in terms of robotic surgery and image analysis.

 

AI-Assisted Surgery

Not only does AI-assisted surgery have an estimated value of $40 billion according to a report from Accenture, but, given robots ability to analyse data from pre-op medical records, they could be used to guide surgeons’ instruments during surgery, leading to a 21% reduction in patients’ hospital stays. This is clearly beneficial for the patient. Of course, less time spent in the hospital equates to reduced costs for insurance companies and hospitals, too.

AI-assisted surgery has also been proven to be more effective, with five times fewer complications compared to surgeons operating alone according to a study published in The Spine Journal.

Today, robots are being used in both eye surgeries and heart surgeries. The Da Vinci, the most advanced surgical robot, successfully operated on a human eye seven months ago. As Ajan predicted, the robot was able to perform complex procedures with greater control than conventional approaches.  

Image Analysis

Up until June of 2018, image analysis was incredibly time consuming. That’s because humans were doing the analysing and it could take two hours or more to see a change in 3D medical scans.

Now, thanks to an MIT-led research team, there is a machine-learning algorithm that can analyse 3D scans up to 1,000 times faster than was previously possible. The changes are essentially studied in real time, allowing surgeons to react more quickly during operations.

AI is also expected to help improve the next generation of radiology tools. Instead of collecting tissue samples through biopsies which has the potential to cause an infection in the patient, the AI-powered tool would show images with very close registration. Currently, these tools are just being piloted.

The Future of AI in Healthcare

AI in healthcare is in its infancy. But, it’s clear that AI tools and systems can help treat patients faster and with more precision than is possible for humans. While we’re still waiting to utilise robots in providing cell therapies, we’re sure to see advancements in how AI processes and interprets data to make the application and administration of medicine easier.

For more stem cell and regenerative medicine news, keep up with Celixir’s blog.

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Hematopoietic Stem Cells: What Are They and What is Their Function?

Most of us understand the importance of blood cells. Red blood cells carry oxygen throughout the body while white blood cells fight infection and help us develop immunity to diseases. But, what about the stem cells that turn into our blood cells?

Scientists, researchers, and doctors have been studying hematopoietic stem cells (HSCs) – the stem cells that form blood and immune cells – for over 60 years, starting after the bombings of Hiroshima and Nagasaki in 1945. They’re now routinely used to treat patients with cancer after chemotherapy.

What Is A Hematopoietic Stem Cell?

Celixir Stem CellsThe hematopoietic system – the system responsible for the production of the bodies’ cellular components – relies on the presence of HSCs.

In fact, HSCs are the only source for the continued production of red blood cells, platelets, white blood cells, and all other cells in the system. When you consider the fact that the average human requires around 100 billion new hematopoietic cells each day, you realise how vital the role of HSCs is in each of our bodies.

Identifiable Traits of Hematopoietic Stem Cells

Because HSCs behave like normal white blood cells, scientists have spent a considerable amount of time identifying key properties and characteristics of the stem cells.

Studies on mice laid the groundwork for our current understanding, and we now know that a HSC has four important properties: it can renew itself, it can differentiate to a variety of other specialised cells, it can mobilise out of bone marrow into circulating blood and it can undergo programmed cell death, called apoptosis.

We also know that there are several different sources of HSCs, including bone marrow, peripheral blood, umbilical cord blood, fetal hematopoietic system and embryonic stem cells and germ cells.

Bone marrow has been used as a source of HSCs for over 40 years  But, peripheral blood is now the preferred source for medical treatments and, as umbilical cord blood banks are receiving more and more support around the world, umbilical cord blood is being considered a more viable option for patients as well. The final two sources – the fetal hematopoietic system and embryonic stem cells – are used for clinical purposes only.

Clinical Uses and Current Applications

Today, tens of thousands of transplants are performed annually around the world.

Medically, HSCs are used to treat patients with acute myeloid leukemia, chronic myeloid leukemia, acute lymphatic leukemia, aplastic anemia, and other primary immune deficiencies and metabolic diseases. In treating cancer patients, HSCs are transplanted after chemo- or irridation therapy to regenerate the hematopoietic system. In most cases, this is achieved in just 2-4 weeks.

The Future

Current clinical trials are looking at gene therapy, vehicles for gene delivery and other gene-editing strategies. There are several promising HSC gene therapies in the early phases of clinical trials, including treatments and products for sickle cell disease , X-linked forms of SCID, and Wiskott-Alrich Syndrome.

A clinical trial  that’s sponsored by the National Heart, Lung and Blood Institute in Maryland is currently recruiting pregnant women to examine the best ways to collect, process and store umbilical cord blood. For babies born with sickle cell disease, the blood collected from the cord and placenta will be stored indefinitely for use in gene therapy treatments later in life. For those babies born without sickle cell disease, the cord blood will be stored for up to 3 years and may possibly be used to treat living or future siblings who have, or may be born, with the disease.

In an attempt to treat both SCID and Wisckott-Alrich Syndrome, lentiviral genes are being used as vectors in Phase I/II trials. So far, there’s been with initial success in treating SCID in both older and younger patients. Likewise, in treating Wiskott-Alrich Syndrome, lentiviral therapy has proven both safe and effective.

Like all regenerative therapies, there are considerable obstacles to overcome and it takes time to research, develop, test, and regulate new products and methods. Nonetheless, over the last five decades, we’ve seen incredible advancements in HSC therapies that have helped doctors and patients treat and even cure several different disorders.

The hope, of course, is that successful clinical trials will lead to approvals by regulatory agencies, as was the case recently for Celixir’s own IND for Heartcl.  Eventually, researchers hope that these therapies will be adopted on a large scale by healthcare systems.

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Stem Cell Research Around the World

Around the world, different countries – and entire continents – are working separately but collectively to develop innovative and life-changing treatments through stem cell research. The field is growing quickly as clinical trials prove that stem cell therapies have the potential to treat or reduce symptoms of diseases, conditions and disabilities that have, up until this point, been untreatable.

Celixir
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In China, stem cells from baby teeth are being used to regrow damaged dental tissue. In Canada, neural stem cells are being used to restore motor impairments caused by cerebral palsy. But, it’s important to recognise that there isn’t one set of laws that govern the globe and some countries are extremely limited by the laws and policies that are in place.

Here’s a look at stem cell research around the world.

Africa

As a continent, Africa is lagging behind others in terms of research and clinical trials related to stem cells with 80% of Mesenchymal stem cell clinical trials occurring in Asia, Europe and North America and just 2.5% occurring in Africa. But, given legislative issues and religious beliefs, this isn’t surprising.

In South Africa, regulatory legislation has existed since 2013 and is mostly concerned with the use of embryo derived stem cells, induced pluripotent stem cells and adult stem cells. But, the legislation isn’t strictly implemented and is often completely overlooked, especially for medical scientists involved in stem cell tourism.

In Egypt, experimental stem cell research (including cloning) is generally accepted whereas, in Tunisia, it’s prohibited, along with research of embryonic stem cells. But Tunisia is the exception, not the rule. In most other African Arab countries, there isn’t clear legislation that controls stem cell research, and governing bodies rely on established religious and ethical beliefs. Without concrete rules and government support, the growth of stem cell research is stifled, and Africa as a whole isn’t able to contribute as much to the field.

Nonetheless, scientists and researchers are still working together at workshops like the one held in Stellenbosch, South Africa. Here, attendees discussed initiatives for developing stem cell therapies for diseases like cancer, diabetes and other non-communicable diseases that have overtaken HIV as the major cause of death in Africa

Asia

Stem cell research in the second largest country in Asia – China – has progressed significantly since the official policy on stem cells was announced in 2015. In fact, stem cell research has become a focal point for the government’s plan for developing the life sciences and biomedical sectors and there’s been an extraordinary amount of money put forth to equip laborites with the latest technology. It’s made an impact. If you look at international publication trends, between 2006 and 2010, China’s stem cell research output jumped from 176 articles to 677.

Elsewhere in Asia, the Indiana Council of Medical Research (ICMR) recently issued a revised draft of the National Guidelines for Stem Cell Research after noting the need for rigorous clinical trials and regulatory processes in developing safe and effective stem cell therapies. As a result, research on in-vitro cultures of intact human embryos beyond 14 days of fertilisation and research on xenogenic cells, xenogenic-human hybrids, modified human embryos, and germ-line stem cells have been banned.

Countries like Japan and Singapore are both seen as leaders in stem cell therapies and, though they might not have the outputs of China – are internationally recognized for the work they continue to do in the field.

Europe

Spain, Italy, Germany and – of course – the United Kingdom are all contributing to stem cell research in a big way. After scientists successfully cloned a sheep in Scotland back in 1996, Britain has been Europe’s leader.  

Nonetheless, Italy and Germany both have some of Europe’s most restrictive legislation regarding stem cell research. Those two countries aren’t alone. Croatia, Lithuania, and Slovakia also have very restrictive policies. The rest of Europe is (for the most part) quite permissive, with Belgium, Sweden and the UK having the least restrictive policies and Austria, Ireland, Luxembourg and Poland having no legislation about hESCs at all.

North America

As the global stem cell market grows, with an expected value of $270.5 Billion by 2025, North America’s market share also grows and is expected to be worth $167.33 by 2025. And, with 33 of the 50 people listed in ‘Most Influential People on Stem Cells Today’ being from North America, it’s clear that the United States and Canada are very involved in research for the stem cell therapeutics market.

There have never been any federal laws in the United States that have banned stem cell research, but there have been restrictions on funding and use. Although, certain restrictions were removed in 2009. In removing the restrictions, Former President Barack Obama had some foresight when he said ‘We will lift the ban on federal funding for promising embryonic stem cell research. We will vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield.’

Nonetheless, stem cell research is still a politically charged issue in the United States and different states have different bans and restrictions.

Canada is contributing as well and, because of a $4 million investment by Canada’s Stem Cell Network in April of 2018, 24 projects involving stem cell research have been planned, involving 95 scientists across the country.

While the field isn’t growing at the same pace around the world, it’s clear that there is a global trend toward more appropriate restrictions and increased funding for stem cell research. For scientists and researchers and patients struggling with diseases ranging from cancer to diabetes, the progress is promising. It’s a global effort and, together, we have the potential to treat and even cure some of the most widespread diseases.

Celixir Stem Cells

How Regenerative Medicine is Helping Treat Cardiovascular Disease

The Impact of Cardiovascular Disease

Cardiovascular disease (CVD) – in all of its forms – is the number one killer in the UK, Europe and the US. More often than not, it has long-term effects, including an enlarged, damaged and less efficient heart muscle which naturally leads to other disabilities and a notably decreased quality of life.

While the affected person certainly bears the burden of such diseases, society as a whole does as well. In a 2006 study, researchers found that CVD cost the UK economy £29.1 billion in 2004, with healthcare costs accounting for 60% of the total. This number is even higher in the US, with healthcare costs associated with CVD just under $300 billion per year.

Current Methods for Treating Cardiovascular Disease

It’s worth mentioning that CVD encompasses all diseases and conditions that affect the heart or blood vessels. Here, we’ll focus on coronary heart disease, which often results in heart attacks and heart failure.

Coronary Heart Disease

According to the NHS, patients suffering from coronary heart disease can be prescribed a combination of medications that help to reduce blood pressure, lower cholesterol or widen the arteries or blood vessels. Unfortunately, many medications have negative side effects and, given that they must be taken long-term, can be costly. Blocked arteries could require interventional procedures, including bypass grafts, angioplasty and even transplants. Success rates depend on numerous factors, including age and lifestyle and, in the case of transplants, there’s understandably a higher demand than there is supply.

What About Prevention?

Currently, prevention of CVD is directed at lifestyle changes. The Mayo Clinic recommends a healthy diet, exercise and stress management for heart health. Of course, their number one recommendation is to stop smoking. But what about medical prevention? It’s clear that there’s a need for preventative methods that will limit ischemic injury and regenerate tissue that’s been damaged before the patient suffers a heart attack, heart failure, or another life-threatening condition.

Regenerative Medicine and the Future of Treatment

Scientists around the world are working tirelessly to turn research into effective treatments and, in the past decade, we’ve witnessed a surge of scientific enthusiasm for regenerative medicine. And it’s well and truly a group effort as it requires scientists and clinicians with different expertise, from cardiology to cell biology to engineering.

California’s Stem Cell Agency  have awarded over $202 million to researchers looking into heart disease, in particular how to create stem cells that can replace the damaged heart muscle and restore the heart’s ability to efficiently pump blood around the body. Other researchers are focusing more on tissue engineering technologies by building artificial scaffolds in the lab, loading them with stem cells and placing them in the heart with the goal of stimulating the recovery of the muscle.

In terms of prevention, Cardiology News reported Dr. Andre Terzic of The Mayo Clinic believes that regenerative medicine will protect against chronic disease and help match healthspan with life span in aging patients.

Of course, Celixir is developing its own life-saving therapies. Heartcel,  an immunomodulatory progenitor (iMP) cell therapy for the treatment of adult heart failure, has been approved for clinical trials in both the UK and the US. EU Phase II trials were completed back in 2016 with overwhelmingly positive results. Most notably, 100% of patients were free from any major adverse cardiac event (MACE), 30% of patients experienced improved heart function and 50% of patients experienced improvements in their quality of life.

Over the next several years, we should see more and more regenerative therapies leaving the research pipeline to be used in clinical environments and, in time, we can hope that deaths and healthcare costs associated with CVD will decline thanks to new treatments.