As most of you know, VetStem spun out a human stem cell company several years ago called Personalized Stem Cells. We like to provide occasional updates for those who may be interested, and it has been a few months since our last update. Since then, there have been some exciting developments regarding clinical trials.

Knee Osteoarthritis Clinical Trial Update

The first FDA investigational new drug approval to research stem cell use secured by Personalized Stem Cells (PSC) was for single knee osteoarthritis. The clinical trial was launched shortly before the COVID-19 pandemic. Despite the challenges presented by the pandemic, PSC was able to safely and successfully complete clinical trial enrollment and treatments by the end of 2020. 39 patients were enrolled in the clinical trial.

Since our last update, Personalized Stem Cells hit another milestone. In January, they announced that all data for the clinical trial was collected and preparations for FDA submission were taking place. And in March, PSC officially announced that all clinical trial data was submitted to the FDA. The preliminary results look very promising. PSC reported that over 79% of patients improved and there were no serious adverse events reported. With the first clinical trial under their belts, PSC plans to launch a larger, placebo-controlled trial later this year.

COVID-19 Clinical Trial Update

Since our latest PSC update blog in March, a lot has happened with the COVID-19 stem cell clinical trial. For reference, PSC developed the investigational new drug and secured FDA approval for the clinical trial shortly after the pandemic began. They went on to license the clinical trial to Sorrento Therapeutics in October 2020.

The most recent news came earlier this month when PSC announced that enrollment was complete for the COVID-19 clinical trial. The results look very promising. Ten patients received allogeneic stem cell therapy for treatment of COVID-19 induced acute respiratory distress. All ten patients were hospitalized prior to treatment and required oxygenation supplementation. And all ten patients were discharged from the hospital shortly after their final stem cell injection. Data from this clinical trial will be used to support a placebo-controlled study which is expected to take place in multiple sites in the United States as well as in Brazil.

Planned Future Clinical Trials

In addition to the phase 2 knee osteoarthritis study, PSC plans to pursue FDA approval for a traumatic brain injury (concussion) study. Stem cell therapy may provide answers and tools to address the chronic debilitation experienced by TBI victims. Recent studies by others have found that stem cells have demonstrated the ability to regenerate damaged nerve tissues which may lead to an improvement in disabilities and thereby the quality of life.

To keep up with Personalized Stem Cells, follow their blog and Facebook page.

May is Pet Cancer Awareness Month and though we cannot give you advice regarding treating your pet’s cancer, we do have some information about using VetStem Cell Therapy in pets with cancer.

VetStem Cell Therapy and Cancer – What You Need to Know

First and foremost, we want to make it known that VetStem cells cannot be used to treat or cure your pet’s cancer. Generally speaking, we do not recommend that pets who have active or recent cancer receive stem cell therapy. VetStem takes a conservative approach when it comes to patients with cancer because there is still a lot that we do not know about stem cells and how they interact with cancer cells. Thus, we err on the side of safety.

As a precaution, we monitored the occurrence of cancer in patients treated with VetStem Cell Therapy and have not seen a higher incidence than what is reported in patients of the same age group that were not treated with stem cells. The literature supports that adult stem cells do not directly turn into cancer cells. There is also literature regarding stem cell therapy in women who have had mastectomies which shows no higher incidence of recurrence of cancer.

Pets with an Orthopedic Condition in Addition to Cancer

There are some patients who have an orthopedic condition in addition to active or recent cancer, that may benefit from stem cell therapy for their orthopedic condition. For these cases, it is important for your veterinarian to consult with one of our veterinarians. Then you and your veterinarian can determine the best course of action for your pet. For some pets, VetStem Cell Therapy may improve their quality of life enough to outweigh the potential risks. If the decision is reached to pursue stem cell therapy, VetStem requires a special waiver to be signed by the pet owner. Some things you and your veterinarian should consider when making this decision are age of your pet, severity of the cancer, other medical conditions, and your pet’s current quality of life.

As most of you know by now, there are multiple conditions for which VetStem Cell Therapy may be a beneficial treatment option. We frequently recommend that pet owners considering stem cell therapy speak to their veterinarian to determine if their pet may be a candidate for VetStem Cell Therapy. But what if your veterinarian is not familiar with VetStem or stem cell therapy?

Considering VetStem Cell Therapy for Your Pet?

You may have seen the many success stories about actual VetStem Cell Therapy recipients and wondered, “Would my pet benefit from stem cell therapy?” Or you may find that you have exhausted multiple treatment options, yet your pet’s condition hasn’t improved as much as you hoped. Whatever your situation may be, it is always important to research all of your options before you decide which therapy to proceed with. If you are considering VetStem Cell Therapy for your pet, we can help you speak to your veterinarian to get a better idea of whether or not this might be a good option to try.

Is VetStem Cell Therapy Right for Your Pet?

We firmly believe that your veterinarian is your best resource when it comes to the health of your pet. He/She is the most familiar with your pet’s health history and has likely examined your pet multiple times, whether for routine exams or sick exams. That being said, your veterinarian may not be familiar with VetStem Cell Therapy or any stem cell therapy for that matter. If you find that that is the case, below are some resources that you can share with your vet.

1. This letter is a great place to start. VetStem’s free, online educational course helps veterinarians better understand the science behind stem cell therapy and educates them on how the VetStem process works.
2. If your veterinarian would like additional information, you can refer them to the literature references on our website. We also have information about Inflammatory Bowel Disease, feline kidney disease, and immune mediated diseases (such as IMHA). For horses, we have multiple case studies on our website.
3. To help determine if your pet is a good candidate for VetStem Cell Therapy, this checklist may be useful.
4. And lastly, our staff veterinarians are available to consult with your vet to determine if VetStem Cell Therapy may help your pet, including a stem cell protocol tailored to your pet’s specific condition. Simply ask your vet to contact us at their convenience. There is no charge for this service!

We always like to remind pet owners that stem cell therapy is not a one-size-fits-all treatment, thus some pets may not be a good candidate for VetStem Cell Therapy. Our goal is to provide as much education and information as possible so you and your vet, with our help, can make the best decision for your pet. As always, if you ever have any questions for us, feel free to reach out! And if you are in need of a VetStem provider in your area, click here and we will send you a list of vets near you.

We have discussed VetStem Cell Therapy for feline kidney disease many times on this blog. For a refresher and success stories, click here. But cats are not the only creatures to suffer from this potentially devastating disease. According to the International Renal Interest Society, “The prevalence of chronic kidney disease (CKD) has been estimated to be 0.5-1.0% in dogs.” While this may seem like a small number, that small percent of dogs may still suffer with a diagnosis like kidney disease.

Unfortunately, like with cats, treatment options for dogs with chronic kidney disease remain limited and can be costly or time consuming. Fortunately, VetStem Cell Therapy has shown some promise in the treatment of canine kidney disease. This is Abby’s story.

Abby is a basset hound mix who was diagnosed with renal disease when she was just one year old. According to her owner, she was very lethargic and would not eat or drink. With minimal treatment options, Abby’s owner elected to pursue treatment with VetStem Cell Therapy.

Abby had her fat collected and received her first stem cell treatment in August 2014. Due to the nature and severity of Abby’s condition, she went on to receive three more stem cell infusions in the four months following her initial treatment. Since then, Abby has continued to receive an intravenous injection of her own stem cells twice yearly and had her most recent treatment just three weeks ago.

According to Abby’s recent bloodwork, her kidney values are in the normal range. Her owner stated, “Six years later and she is doing great. She is a normal, happy healthy dog. I have her injected with her stem cells every six months and monitor her kidney levels through bloodwork twice a year.”

Of course, it is very heartwarming to hear a story like Abby’s. But each patient is different and stem cell therapy may not be an effective treatment option for all patients with kidney disease. If your pet has kidney disease, it is best to speak with your veterinarian to determine if stem cell therapy may be a good option for your pet. Or you can contact us to receive a list of VetStem providers in your area.

Next week, May 2^nd-8^th, is National Pet Week! Founded in 1981 by the American Veterinary Medical Association and the Auxiliary to the AVMA, National Pet Week “celebrates the pets that enrich our lives and encourages responsible pet care every day of the year.”

Each day of National Pet Week has a specific theme. See below for a list of themes provided by the AVMA with a link to helpful information for both new and seasoned pet owners alike:   

Daily Themes

Each day of the week focuses on a different topic essential to responsible pet ownership:

• Sunday: Choose well: Commit for life
• Monday: Socialize now: New doesn’t have to be scary
• Tuesday: Nutrition and exercise matter
• Wednesday: Love your pet? See your vet!
• Thursday: Travel with care
• Friday: Emergencies happen: Be prepared
• Saturday: Plan for their care: Give them a lifetime of love

You may notice that several of the above themes emphasize responsible pet ownership, which includes routine veterinary care. On this blog, we frequently talk about diseases and ailments which may prompt visits to the vet. But routine care is very important to maintaining your pet’s health. Preventative care, such as regular wellness exams, can lead to the detection and diagnosis of problems that may otherwise go unnoticed until it is too late. If a problem is detected in its early stages, it is more likely to be treated and resolved with less expense, less difficulty and better success.

But routine veterinary care is not the only way to keep your pet happy and healthy! Exercise and stimulation are important too! We have blogged many times about the benefits of walking your dog such as weight management and a reduction of osteoarthritis symptoms. But taking a walk can provide mental stimulation as well. All the new smells, sights, and sounds beyond your dog’s normal environment provide great mental stimulation. A dog who is well stimulated tends to be happier and more relaxed at home and may demonstrate less destructive behaviors. And don’t forget about cats! Though they tend to be lazier than our canine companions, cats benefit from routine exercise and mental stimulation as well. National Pet Week starts on Sunday so don’t forget to celebrate your pets!

World Veterinary Day is an annual holiday created by the World Veterinary Association (WVA) to “…promote the veterinary profession and work on improving animal and human welfare, the environment, food safety, animal transport, and quarantine.” It is celebrated on the last Saturday of every April and this year is the 20^th anniversary of its first celebration. Each year there is a theme and this year’s theme is, “Veterinarian Response to the COVID-19 Crisis.”

The year 2020 brought some serious challenges, and many people stepped up in exceptional ways to meet those challenges. Veterinary professionals were among those people. Animals did not stop needing care, and in fact, so many dogs and cats were adopted from shelters in 2020 that some shelters were completely emptied out at times! In addition, pet owners brought their existing pets to the vet more often in 2020 than they had in the past. Pet owners reported that quarantine and social distancing from other humans changed their relationship with their pets by fostering the human-animal bond and thus, they were more attune to their pet’s health needs. This meant that veterinary visits increased during a time when staff were being furloughed and social distancing was mandated. Veterinarians responded as they always do, with grace and fortitude. They navigated these uncharted waters by developing curbside service, telemedicine platforms, and fought for the right to be considered essential workers so they could keep the doors open for animals in need. Veterinary professionals forged ahead with the difficult task of maintaining a high level of pet care while trying to keep themselves, their staff and pet owners safe and healthy during a time of ever-changing rules and regulations.

Veterinarians also demonstrated the breadth of their caregiving spirit during this past year. They donated supplies to the human medical community, including PPE and respiratory ventilators early in the pandemic when resources were scarce, critical illness rates were high, and the disease was spreading rapidly. Then in April 2020, Great Britain called for assistance from their veterinarians to act as respiratory assistants. New York City asked veterinarians to care for the bodies of those who passed, ensuring they were treated with dignity and respect. And more recently, veterinarians in the United States have been authorized to administer COVID vaccines to their fellow humans in need, prompting the USDA to swiftly deploy their vets to aid in this monumentally important endeavor.

Equally as important as all the brave souls in the typical clinical practice setting, were the veterinarians that the public might not think of when they think of a “vet.” Agricultural veterinarians continued to make sure our food sources were safe and remained in steady supply. Veterinary pathologists, virologists, and epidemiologists diagnosed, studied, and reported on COVID-19 infections in animals, helping to assure the public that pets were considered a low risk for spreading the disease to humans. Veterinary medical school professors, like other teachers, found new ways to train their students when they could not be together in the classroom or the hospital. Government and private sector-employed laboratory veterinarians were among those in the medical and pharmaceutical fields working tirelessly to create COVID-19 treatments and vaccines. Veterinarians in the biotechnology field, such as veterinarian led VetStem, promoted the “One Health” sometimes termed, “One Medicine” concept by collaborating with the human medical community and sharing their wealth of knowledge about coronaviruses across different animal species. You can learn more about One Health here. To that end, VetStem Biopharma and sister company, Personalized Stem Cells, jumped into action in 2020, gaining FDA approval to begin a clinical trial treating human COVID-19 patients with stem cells. By March 2021 we celebrated the successful treatment of nine people who had been significantly afflicted with the disease. These patients had all been in a hospital ICU, and after receiving intravenous (IV) treatments with stem cells, they all made it back home to their families. This is a relatively small number of patients, but the results are certainly promising.

Despite the chaos, uncertainty, and heartbreak that the COVID-19 pandemic has brought to this world, veterinarians have been steadfast in their dedication to promote the health and safety of all beings on this Earth, and I can honestly say that I have never been more proud to be a member of this special group of people.

Kirby is a Pembroke Welsh Corgi who has been competing in agility since he was just one and a half years old. Several years ago, he began experiencing intermittent lameness in his hind end, most notably in his hips and left knee. He was diagnosed with osteoarthritis and cruciate ligament injuries.

Because he is such an active dog, his owner pursued several treatment options to help him feel more comfortable. Initially, he was treated with cold laser therapy, underwater treadmill, and a nonsteroidal anti-inflammatory. This combination would help Kirby for a little while and then he would go back to being lame. Next, his mom pursued treatment with platelet therapy. Kirby received concentrated platelet injections into both hips and both knees. His mom reported that he responded well, and the results lasted for a year after the platelet injections.

But after that year, Kirby was sore again. That is when his mom elected to have Kirby treated with VetStem Cell Therapy. His veterinarian collected fat tissue from his abdomen in a minimally invasive anesthetic procedure. His mom described the procedure as such, “The minor surgery to harvest the fat was easy and he recovered quickly.” VetStem laboratory technicians processed Kirby’s fat to concentrate and extract his stem and regenerative cells. Kirby’s stem cell injections were sent back to his veterinarian for treatment. He received one injection into each hip, each knee, and also intravenously.

Approximately two months after treatment with VetStem Cell Therapy, Kirby was doing much better. According to his mom, he was able to return to agility, competing about once a month with an 80% qualifying rate. In addition, he hikes 12-15 miles with his mom each week. She stated, “I’m so grateful to VetStem for their help and that they have his cells in storage so we can give him more injections in the future if needed!!”

Kirby’s treatment was nearly two years ago and according to his mom, he was still doing well and competing in agility trials as of late 2020. He has not required a repeat injection of stem cells to date!

If you think your dog may benefit from stem cell therapy, speak to your veterinarian or contact us to receive a list of VetStem providers in your area.

There are a multitude of diseases outside of orthopedic conditions for which treatment with stem cells has been successful, while others do not respond as well. At VetStem, we work with veterinarians and their pet owners on a case-by-case basis to determine if stem cell therapy may be a viable treatment option. Oftentimes, these patients have diseases that are challenging to treat or current standard therapies are lacking in clinical data. One of these diseases is canine atopic dermatitis (also known as allergic dermatitis or atopy).

What is Canine Atopic Dermatitis?

Canine Atopic Dermatitis (CAD) is what most dog owners call “allergies.” The primary symptom is itchiness, usually in the feet, face, ears, armpits, front legs, and/or abdomen. Scratching and licking can lead to hair loss, hotspots or other irritations, skin thickening and more. Secondary skin infections and/or ear infections can develop and make symptoms worse.

CAD is a genetic disease that predisposes a dog to certain allergen sensitivities. The allergen(s) are environmental such as pollens, molds, dust mites, dander from other animals (yes, even human dander) or normal skin organisms. While there is still much to learn about CAD disease, we have learned that atopic dermatitis occurs due to a skin barrier defect, which allows allergens to absorb deeper into the skin where the immune system can access them. Thus, when an atopic dog comes into contact with the offending allergen(s), their body creates a skewed immune response leading to an allergic reaction. It is worth mentioning that the symptoms of CAD are very similar to those caused by food allergies or flea allergies and some patients may be affected by more than one condition. Your veterinarian is your best resource for determining if CAD is the cause of your dog’s itchiness.

Traditional Treatments for CAD

In an ideal world, allergic dogs would avoid the allergens they are sensitive to, but CAD allergens are often airborne and thus, even staying indoors does not eliminate exposure. Frequent bathing is helpful in removing the allergens from the skin and allergy desensitization injections can be tailored to each dog after extensive allergy testing is performed, however both of these treatments require much time and effort that some families may not be able to accommodate. While more innovative treatments have been developed in recent years such as oral medications or canine antibody injections, truly effective treatment options remain limited, may be expensive, and do not cure the condition but rather control the “itchiness” symptom. CAD is a lifelong disease that will require lifelong management.

Stem Cells for CAD – Mechanisms of Action

One tool that stem cells utilize is immunomodulation, or the ability to modify the immune response. Since there is an immune component to atopic dermatitis, it is theorized that stem cells can down-regulate a dog’s immune response and therefore, his/her body may not overreact to specific allergens and he/she will not become overly itchy.

Stem Cells for CAD – The Research is Limited

There are very few studies on the use of adipose derived stem cells to treat canine atopic dermatitis. And the two most relevant studies reached conflicting results. While one study showed no significant improvement of clinical signs or symptoms, the second study showed significant improvement. In addition, results from the second study lasted for at least six months. Because studies are limited, we can not say for certain that stem cells improve symptoms in dogs with atopic dermatitis.

What about anecdotal evidence?

Multiple veterinarians have utilized VetStem Cell Therapy for atopy in both dogs and cats. Some veterinarians have reported an improvement in symptoms after treatment with stem cells. In some cases, patients have required less allergy medication than before stem cell therapy. That being said, some patients have not experienced improvement in symptoms. So, while we can’t say that stem cells will help every dog with atopic dermatitis, we do believe that some benefit from treatment with VetStem Cell Therapy based on the responses reported from the veterinarians and owners who have implemented it.  

As always, it is important to note that each patient is different and therefore some may not respond at all to stem cell therapy. If you think your allergic dog may benefit from treatment with VetStem Cell Therapy, speak to your veterinarian or contact us to find a VetStem provider in your area.

Next Wednesday, April 7^th, is National Walking Day! Did you know walking can help reduce symptoms of osteoarthritis in dogs? Osteoarthritis (OA) is the most common form of arthritis in dogs (and people!) and affects approximately one quarter of the canine population. It is a degenerative disease in which the cartilage within a joint breaks down, causing changes in the surrounding bone. Common symptoms of OA include pain, stiffness, and reduced range of motion. In dogs, the majority of OA cases stem from a developmental orthopedic disease such as joint dysplasia. It can also develop as a result of an injury such as a cruciate ligament tear.

Exercise Reduces Symptoms of Osteoarthritis

While some may believe that reduced usage of the affected joint will lead to improvement of symptoms, it appears the opposite is true. Studies have found that regular physical activity can actually benefit dogs with OA and lead to an improvement in symptoms.

The type of exercise is very important, however. For instance, high impact exercises such as running and jumping may lead to increased inflammation and pain and therefore should be limited. On the other hand, regular joint-friendly exercises are ideal for dogs with OA. These are low-impact and put less stress on the body, thereby reducing the risk of injury. Some joint-friendly exercises include swimming and leash walks.

Benefits of Walking for Dogs with Osteoarthritis

Walking can be a great way to keep dogs physically active. It is easy on their joints and comes with a number of benefits that can lead to healthier, less painful joints. Walking regularly can help dogs lose weight, thereby causing less stress on the joints. It can also help strengthen the muscles and supporting soft tissue structures around the joints, promoting increased joint stability. In addition, it increases joint fluid circulation which is beneficial to maintaining healthy joint cartilage.

Of course, every dog is different. So as always, it is best to check with your veterinarian to determine the best exercise routine for your dog.

For those of you who follow our blog, you probably know that we launched a human stem cell company in 2018. Click here for a refresher. Since then, Personalized Stem Cells (PSC) has received FDA approval for two investigational new drug (IND) applications. The first FDA approved clinical trial was for the treatment of knee osteoarthritis and is currently in the end stages. The second IND was for a COVID-19 clinical trial.

Knee Osteoarthritis Clinical Trial Update

Despite the COVID-19 pandemic, PSC was able to successfully complete their first clinical trial in 2020. At the start of the pandemic, new patient enrollment was put on a brief hold. Once doctors were able to safely resume in-clinic procedures however, enrollment picked up again. By August 2020, PSC announced that patient enrollment was complete. Just a few short months later, the company announced that all clinical trial participants had received treatment.

Finally, in January, PSC announced that all the data was collected for the clinical trial and preparations for FDA submission began.  Once all of the data is submitted to the FDA, and assuming everything goes as planned, it is PSC’s goal to launch a larger, placebo-controlled knee trial later this year. Stay tuned for more information!

COVID-19 Clinical Trial Update

Another major accomplishment was receiving approval for a COVID-19 clinical trial. In the early days of the pandemic, PSC went to work to manufacture stem cells and secure FDA approval for a clinical trial to study the effects of stem cell therapy to treat COVID-19. We announced the news back in July here on the VetStem blog. But the good news didn’t stop there!

In October 2020, PSC entered into a licensing agreement with Sorrento Therapeutics and granted global rights to its allogeneic (donor-derived) stem cell program, including the COVID-19 clinical trial. This was a lucrative move for the company and allowed PSC experts to return focus to autologous (patient-derived) stem cell treatments.

Sorrento Therapeutics has reported positive preliminary results both in safety and efficacy for the COVID-19 clinical trial. At the time of announcement, four patients had completed stem cell treatment for COVID-19 and all four were discharged from the hospital. Additionally, there were no infusion related adverse events reported in any of the patients. Read more here.  

All in all, it was a challenging, yet rewarding year for our human stem cell company, and very promising for potential patients! We continue to be amazed at the power of regenerative medicine and look forward to PSC launching additional FDA approved clinical trials in 2021!