This patent covers methods for extracting and using adipose tissue-derived stem cells to treat or prevent inflammation at the site of musculoskeletal injury in any mammal, including humans.

PSC is working with the FDA to provide alternatives to unregulated, in-clinic stem cell processing and unapproved “regenerative” therapies. The current environment of in-office, unregulated manufacturing of stem cells by physicians has come under serious regulatory action by the FDA, FTC, and the Federation of State Medical Boards.

PSC recognized that the path to success in regenerative medicine was to develop FDA-regulated drugs. Leveraging the team’s extensive experience and success in veterinary medicine, the company was launched to develop treatments for serious human conditions.

Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has received FDA approval for a New Drug (IND) application for use of a person’s own adipose-derived stem cells to treat their osteoarthritis. The first clinical trial, uses stem cells as a treatment of osteoarthritis in the knee.

Safety was the primary objective of this study and there were no serious adverse events reported. The efficacy of the experimental cell therapy in knee osteoarthritis was measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and showed that 79.3% of the patients improved above the “minimal important change” (MIC) with an average improvement over baseline of 2.2 times the MIC. The KOOS measures pain, other symptoms, daily function, sports, and knee related quality of life outcome sub-scales.

All nine patients were in the hospital ICU with poor oxygenation and all nine patients were discharged from the hospital within days after completing the stem cell treatments. In addition, there have been no infusion related adverse events reported in any of the patients.

The objective of this non-randomized, Phase 1b study is to evaluate the safety and preliminary efficacy of adipose-derived stem cell therapy for the treatment of ARDS resulting from infection with COVID-19. Patients enrolled in the clinical trial will receive one intravenous infusion of stem cells every other day for a total of three infusions.

All nine patients were in the hospital ICU with poor oxygenation and all nine patients were discharged from the hospital within days after completing the stem cell treatments. In addition, there have been no infusion related adverse events reported in any of the patients.

The objective of this non-randomized, Phase 1b study is to evaluate the safety and preliminary efficacy of adipose-derived stem cell therapy for the treatment of ARDS resulting from infection with COVID-19. Patients enrolled in the clinical trial will receive one intravenous infusion of stem cells every other day for a total of three infusions.

The study yielded remarkable results. Throughout the study duration, adverse events, laboratory parameters, vital signs, and physical examination findings were closely monitored. The findings showcased robust tolerability, with no significant safety concerns observed. Evaluation of knee pain and function, as gauged by the Knee Injury and Osteoarthritis Outcome Score (KOOS), demonstrated notable improvements. These positive effects were sustained for up to 12 months, with the majority of participants expressing satisfaction with the outcomes.

PrecisePRP™ is unlike any PRP mechanical kit currently on the market. PrecisePRP™ does not require a blood draw or centrifugation, nor refrigeration, making it a truly off-the-shelf product that is easy and convenient. Perhaps more important is the uniformity and consistency that PrecisePRP™ provides with its unique patent pending manufacturing process. Each vial of PrecisePRP™ contains a consistent dose of 4 billion platelets per vial at a concentration of 500,000 platelets per microliter and is leucoreduced with less than 1500 white blood cells per microliter. Each lot is quality tested before release.

PrecisePRP™ Canine & Equine was reviewed under the FDA animal cells, tissues, and cell- and tissue-based products (ACTPs) program