It is with immense pride that we announce our human company, Personalized Stem Cells, recently received FDA approval to treat COVID-19 patients in an upcoming clinical trial. Read PSC’s blog below:

Personalized Stem Cells (PSC) recently received FDA approval to treat COVID-19 patients with stem cells in an upcoming clinical trial. In April, we announced that we filed an expedited IND at the request of the White House Coronavirus Task Force to treat hospitalized COVID-19 patients. This approval is incredibly significant because patients will be treated with disease-screened, quality tested donor cells as opposed to their own stem cells. This is known as allogeneic stem cell therapy and is different from PSC’s current FDA approved clinical trial in which patients receive their own stem cells (autologous) to treat knee osteoarthritis.

Stem Cell Therapy for COVID-19

PSC has become a leader in the field, recently publishing a landmark peer-reviewed scientific article on the rationale behind using stem cells to treat COVID-19. Mesenchymal stem cells (MSCs) have demonstrated the capacity to inhibit lung damage, reduce inflammation, dampen immune responses and aid with alveolar fluid clearance. Additionally, MSCs produce molecules that are antimicrobial and reduce pain. Recently, the application of MSCs in the context of ongoing COVID-19 disease and other viral respiratory illnesses has demonstrated reduced patient mortality and, in some cases, improved long-term pulmonary function.

Based on information out of Israel, China, Spain and the United States, stem cells have shown promising effectiveness in the treatment of the major medical lung issues caused by COVID-19. Israel recently announced 100% recovery in seven COVID-19 patients who were treated with stem cell therapy. Spanish medical investigators reported on an adipose stem cell study in which 13 COVID-19 patients were treated using a protocol very similar to the one just approved for PSC. According to the results, the mortality rate in the treated patients was significantly decreased.

FDA Approved Clinical Trial: CoronaStem 1

The initial clinical trial, named CoronaStem 1, will include 20 COVID-19 patients hospitalized in California. Once complete, PSC hopes to move into a larger Phase 2 clinical study and potentially into FDA Expanded Use programs or Emergency Use Authorization, which could allow for many more patients to be treated.

In order to rapidly ramp up the production of stem cells for use in the clinical trial, PSC collaborated with Calidi Biotherapeutics, a biotechnology company based in San Diego, California. Calidi provided disease-screened, quality stem cell lines to PSC, enabling us to accelerate the stem cell drug manufacturing process. In addition, sister company and CRO, VetStem Biopharma, provided manufacturing and regulatory support to help make FDA approval a reality.

PSC is not currently soliciting patients for inclusion in CoronaStem 1 due to the limited number of hospitals participating in the study. For more information regarding future clinical trials, please contact us here.

It has been a little over a month since our last update regarding COVID-19 and animals in the United States. Altogether, the USDA has reported 18 confirmed cases of SARS-CoV-2 in animals in the United States. Of these 18 cases, 7 of them were tigers and lions at the Bronx Zoo. The remainder were domestic cats and dogs.  

On the whole, the narrative remains the same as our previous updates. Based upon the limited number of confirmed positive cases, there are several probable conclusions we can draw:

1. Dogs and cats (as well as other species) can contract COVID-19

2. Most infected pets presumably contracted the virus from an infected pet owner/caregiver

3. Symptoms in dogs and cats tend to be mild, if not completely absent

4. Dogs and cats do not appear to be a source of COVID-19 and the risk of animals spreading the virus to humans appears to be low

With this information, the best we can do is be prepared. According to the CDC and the American Veterinary Medical Association, there are some steps we can take to ensure the well being of ourselves and our families, both 2- and 4-legged.

• Do not allow pets to interact with people or other animals outside of the home. Keep dogs on a leash and cats indoors and practice social distancing. Avoid public places where large groups of people and animals gather such as dog parks.
• If you or a household member become sick with COVID-19, whether suspected or confirmed, avoid interaction with your pets as much as possible. If you must interact, wash your hands before and after interaction, wear a face covering (mask), and do not share items such as food, dishes, bedding, or towels.
• It is wise to prepare an emergency kit for your pets should you be required to quarantine. The AVMA recommends your kit include at least 2 weeks’ worth of food and any needed medications. Additional items to include may be bedding, toys, and any other items to help keep your pet(s) healthy and happy.

For up-to-date information and other resources regarding animals and COVID-19, you can visit the AVMA website and CDC website.

Heartbeat is a 22-year-old Oldenberg gelding. When he was 16, he started to show signs of lameness in his left front leg. Extensive examinations and diagnostics revealed his lameness was due to injuries to his lateral collateral and impar ligaments in his left front hoof.

His veterinarian, Dr. Patricia Doyle of Mid-Atlantic Equine Medical Center, recommended treatment with VetStem Cell Therapy and began the process by collecting fat from Heartbeat’s tailhead. The fat was processed at the VetStem laboratory and 3 syringes of Heartbeat’s own stem cells were shipped back to Dr. Doyle for injection into his injured leg.

In addition to VetStem Cell Therapy, Dr. Doyle recommended a slow, regimented rehabilitation program for approximately 8-12 months following Heartbeat’s stem cell treatment. Veterinarian’s may or may not recommend rehabilitation in conjunction with VetStem Cell Therapy depending on several factors such as the condition being treated and the severity of the condition. Some other horses that benefited from rehab after receiving VetStem Cell Therapy are Jesse, Atlas, and Woody.

Following stem cell therapy and one full year of rehab, Heartbeat returned to the jumper ring and has competed successfully at the lower levels for the past 6 years. Now, at age 22, his owner reports, “He remains sound working six days a week on average and still winning in the show ring.” If your horse has suffered an injury or is suddenly lame, speak to your veterinarian about whether or not VetStem Cell Therapy may help. Or contact us to receive a list of VetStem providers in your area.

Emma is a 12-year-old Australian cattle dog. She has arthritis in her elbows and carpus (wrist) and also has spondylosis, a spinal condition in which bony spurs form along the vertebrae. Fortunately for Emma, her mom is a veterinarian and elected to have Emma treated with VetStem Cell Therapy.

In 2018, Emma had her fat collected to begin the process for stem cell therapy. Her initial treatment consisted of three joint injections for her elbows and right carpus, one intravenous injection, and one injection that was given along the muscles of her spine. She responded well to treatment.

After approximately one year, Emma began to slow down again. Her veterinarian requested that Emma’s stem cells be put into culture to grow more stem cell doses for treatment. Once the culture process was complete, Emma received a second round of stem cell injections just over one year after her first treatment.

Again, Emma responded well to the stem cell treatment but, according to her mom, began to show signs of discomfort approximately one year after her second stem cell treatment. Her mom stated, “What we notice is weakness to her back legs and mild limping on her front legs. She will also lick at her carpi and elbows when her pain is acting up. When her rear legs are weak, we notice she has trouble jumping onto the couch. She also needs to stop and rest frequently when we take her on walks.” Emma received a third stem cell treatment in June of this year. Her mom stated, “I know she would not be alive today if it wasn’t for the stem cell treatment.”

Emma’s story is not uncommon. Many VetStem patients have undergone repeat injections when their symptoms start to flare up again. One such patient is Bodie, the champion Bird Dog with hip dysplasia. Fortunately, VetStem offers stem cell storage for patients who receive VetStem Cell Therapy. If available, the stored stem cells can be used for future treatments as needed. For more information about cell storage, read our recent blog on the subject.