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.

Knee Osteoarthritis Clinical Trial

The first FDA approved clinical trial was for the treatment of knee osteoarthritis. Data was submitted to the FDA for this trial earlier this year and the 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 in the coming months.

COVID-19 Clinical Trial

The second IND was 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 2020 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 them global rights to their 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.

Phase 1b COVID-19 Clinical Trial Results

Results from the first COVID-19 clinical trial were very promising. The initial Phase 1b clinical trial was conducted in California at UCSF Fresno. In the initial study, ten patients that were hospitalized and required oxygen supplementation, were all discharged from the hospital shortly after completing treatment with stem cells. These promising results helped secure approval for the Phase 2 study in Brazil earlier this year.

Brazilian Phase 2 COVID-19 Clinical Trial

The latest news from Sorrento is that the first patient was recently enrolled in the Brazilian COVID-19 study. This trial, which, like the Phase 1b trial is being conducted by Sorrento Therapeutics, is a randomized, placebo-controlled study designed to evaluate the safety and efficacy of three allogeneic (donor-derived) mesenchymal stem cell infusions administered on varying schedules in 100 patients suffering from acute respiratory distress syndrome (ARDS) as a result of COVID-19 infection. The hope is that the results of this trial will mirror the results of the initial clinical trial and that this treatment modality will eventually become more accessible.

We couldn’t be prouder of the work we do here at VetStem and also at Personalized Stem Cells. Without the 15+ years of VetStem data from veterinary stem cell treatments, PSC would likely not be here. And to know that we contributed to potentially saving lives affected by COVID-19 is really something spectacular. We also want to thank all of YOU, our pet owners and veterinary clients, for trusting VetStem to handle your pets’ and patients’ stem cells. We couldn’t do what we do without you!

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.  

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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!

As we shared in a recent blog, VetStem launched a human stem cell company known as Personalized Stem Cells, Inc (PSC) in late 2018.  PSC was founded to advance and legitimize human regenerative medicine through FDA approved clinical trials.  As such, it was announced in June that PSC submitted their first FDA-IND (“Investigational New Drug”) application for the treatment of osteoarthritis, with the first clinical trial to be for patients with OA in the knee.

In less than one year since the company’s formation, PSC recently announced that their application was approved for conducting clinical trials for the treatment of osteoarthritis using stem cells.  The fast approval was in large part due to VetStem’s extensive experience and data from stem cell therapy in the veterinary field.

This is the first of several planned INDs that PSC will seek FDA approval for.  Similar to the VetStem model, they plan to start with orthopedic conditions and eventually expand to include other medical conditions.  Like VetStem, PSC will follow strict quality control and safety protocols.

For the first clinical trial, PSC has enrolled a limited number of clinical sites around the U.S. to provide treatment for knee osteoarthritis using stem cells. The enrolled physicians are among the most experienced stem cell physicians in the country.  You can contact PSC for clinical trial information, clinical trial site locations, or investment information.

VetStem was recently featured in a documentary about Regenerative Veterinary Medicine called Animal Pharm: Where Beasts Meet Biotech.  We’ll share more about this soon, but one interesting aspect of the film is the commentary on how advances made in veterinary medicine are translating into the human medical field.

It’s not an uncommon narrative: a new medical technology or drug emerges in the veterinary field and after research and outcome data are compiled, scientists and doctors begin to wonder how humans may benefit from the same technology.  Known as translational medicine, Animal Pharm takes a look at how we’ve begun to apply what we know about stem cell therapy for animals to human medicine.

As a leader in the field of Regenerative Veterinary Medicine, VetStem strives to remain one step ahead and we recently announced the launch of our human stem cell company, Personalized Stem Cells, Inc. (PSC).  PSC was launched to advance and legitimize human regenerative medicine, which until recently, has been largely unregulated.  Recent regulatory action by the FDA, FTC, and the Federation of State Medical Boards has made it clear however that the only allowed use of stem cells will be through legitimate FDA clinical trials.

As such, PSC plans to launch FDA approved human stem cell clinical trials later this year.  The company recently announced their first Investigational New Drug application to the FDA for the treatment of osteoarthritis in the knee.  If you are interested in more information, you can contact PSC here.

These are exciting times we’re living in.  Though our primary goal has been to improve the lives of animals, it was always in the back of our minds that the technology we’ve worked so hard to develop and advance might one day be able to help humans also.  We are excited to see this dream becoming a reality.