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The U.S. FDA development steps required for a stem cell product approval

The U.S. FDA development steps required for a stem cell product approval

by Ashley | Aug 19, 2022 | Blog, FDA Approved Clinical Trial, Stem Cell

American patients have access to the safest and most advanced healthcare and pharmaceutical system in the world.1 But, to be able to market a drug treatment for therapeutic use in the United States, U.S. Food and Drug Administration (FDA) approval is required. Other...
Personalized Stem Cells Announces Stem Cell Knee Arthritis FDA-Approved Phase 1/2a Clinical Trial Results

Personalized Stem Cells Announces Stem Cell Knee Arthritis FDA-Approved Phase 1/2a Clinical Trial Results

by Valet | Mar 30, 2021 | Clinical Trial, FDA Approved Clinical Trial, Press Release

Personalized Stem Cells, Inc (PSC), a clinical stage biopharma cell therapy company, announces the results of its single knee osteoarthritis phase 1/2a clinical trial. The final study report has been submitted to the FDA for review and in support of a full-scale...
First Patients Treated in COVID-19 Stem Cell Clinical Trial

First Patients Treated in COVID-19 Stem Cell Clinical Trial

by Valet | Feb 19, 2021 | Blog, Clinical Trial, COVID-19, FDA Approved Clinical Trial

In 2020, Personalized Stem Cells developed and secured FDA approval for a COVID-19 stem cell clinical trial. In October of last year, we announced that we out-licensed our allogeneic stem cell program, including the COVID-19 therapy, to Sorrento Therapeutics....
Knee Osteoarthritis Clinical Trial Update: Data Collection Milestone

Knee Osteoarthritis Clinical Trial Update: Data Collection Milestone

by Valet | Jan 22, 2021 | Blog, FDA Approved Clinical Trial, Knee Osteoarthritis, Stem Cells for Knees

2020 was a whirlwind of a year for most of us. Individuals, families, and businesses all over the world were affected by the global pandemic. Nobody expected the year’s crazy turn of events, and most of us found ourselves in uncharted territory when it came to...
Personalized Stem Cells Announces All Data Collected from FDA Approved Stem Cell Clinical Trial for Knee Arthritis

Personalized Stem Cells Announces All Data Collected from FDA Approved Stem Cell Clinical Trial for Knee Arthritis

by Valet | Jan 12, 2021 | Clinical Trial, FDA Approved Clinical Trial, Press Release

Personalized Stem Cells, Inc (PSC), an adipose-derived stem cell company, announces that the data collection process is complete for their Phase I FDA approved stem cell clinical trial for the treatment of knee osteoarthritis. In early October 2020, the company...

FDA Approved Stem Cell Clinical Trials

by Ashley | May 22, 2020 | Blog, FDA Approved Clinical Trial, Stem Cell Therapy

Stem cells can differentiate into multiple tissue types such as bone, cartilage, muscle, and even cardiac and nerve tissues. They are sometimes called the “master cells” of the body. Literature demonstrates that stem cells have the ability to repair, regenerate, and...
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