“I am sitting here at the office, just finishing the first draft of the clinical study report for PSC-CP-001. I am deeply moved and grateful for the incredible efforts you have all made in advising, enrolling patients, completing data forms, monitoring, and all other manner of work to bring this glimmer of an idea from 2018 to a completed first study in 2020. We overcame the FDA, the reluctance of patients to enroll, and the personal and professional perils of COVID-19 pandemic. Many studies and companies were just shuddered. You all kept the faith and pivoted to Zoom and remote exams, along with the help from FDA to allow us to keep moving. In the midst of all this, we also managed to file a new IND for COVID-19, manufacture the cells, get FDA approval, and start the study (2 patients already treated and high hopes). Honestly, Chris and Sue have been the steady Eddy’s for me assuring you all had the right resources and instructions, and each of the site coordinators are Saints. And Carolyn’s manufacturing crew work OT to make sure we extracted the most cells and had a safe product to ship. And Mike has raised capital and kept the company running including doing an amazing license deal that brought us additional capital to keep burning the midnight oil.
The data is awesome. The cells were safe. Not a single Serious Adverse Event. Great data. In the coming week or two I will shepherd the final report through data analysis, editing, investigator review (yes you get to review!) and final QC/QA review. With final signatures it will go to FDA. Shortly behind this submission will be the request to conduct a full blinded placebo-controlled and randomized trial.”
Bob Harman, DVM, MPVM
CEO, Personalized Stem Cells, Inc.
CEO, VetStem Biopharma, Inc.
Personalized Stem Cell Clinical Trial Updates
In 2021, we also plan quickly to apply for IND (FDA abbreviation for Investigational Device Exemption) for cultured adipose cells for knee arthritis. Later in the year, we plan to apply for Clinical Trials to treat multiple orthopedic conditions including knees, hips and shoulders. More specific information will be posted on this Blog as applications are submitted and/or approved. In the meantime, while you are waiting, our Stem Cell, Platelet Rich Plasma and Growth Factor options are available to relieve arthritic symptoms and improve your functional capacity. While I am waiting for my participation in several of the upcoming trials for hips and knees and hopefully spine, either this week or next, I will be undergoing a proprietary Platelet Rich Plasma /Growth Factor intervention at the knee to enable me to ski in February without restrictions.
To learn more about my treatment options, visit my web site at www.Sheinkopmd.com.
To schedule an office visit, call (312) 475-1893. To stay updated on the Clinical Trial developments, don’t miss reading my weekly Blog