VetStem Biopharma has long been a leader in veterinary stem cell therapy with clinical, regulatory and manufacturing experience. In October 2018, VetStem authorized the formation of Personalized Stem Cells, Inc ("PSC"), a human adipose stem cell company. VetStem has licensed to PSC its stem cell patents, data, and FDA filings to launch into human stem cell clinical therapy. PSC will conduct a series of FDA-IND approved clinical trials starting with uses in orthopedics. With one of the first cGMP cell manufacturing facilities in California, VetStem will be the contract manufacturer of stem cells for use in these Phase I human studies by the PSC network of human physician investigators.
The current environment of in-office manufacturing of stem cells by physicians has come under serious regulatory action by the FDA, FTC, and the Federation of State Medical Boards. It is clear that the only allowed use of stem cells will be through legitimate FDA clinical trials and with manufacturing in a controlled environment. VetStem has recruited experienced executive management including CEO Mike Dale, a co-founder of VetStem and experienced serial entrepreneur.
PSC has successfully completed its seed investment round and has begun operations. The first clinical trials are anticipated to begin in early 2019. For more information about becoming an investigator or enrolling in a clinical trial, email Mike Dale at mdale@pscells.com or visit the PSC website at http://www.pscells.com.
VetStem is a 75% owner of PSC and provides contract services including cGMP manufacturing for PSC. VetStem is in the process of raising a final round of capital to complete its approved pivotal FDA licensing trial for canine osteoarthritis.
Read the full story at https://www.prweb.com/releases/vetstem_biopharma_launches_human_stem_cell_company_in_san_diego/prweb16099119.htm.