Press Releases

VetStem Biopharma Secures FDA Approval of First Human IND for its Subsidiary, Personalized Stem Cells, Inc.

VetStem Biopharma, a veterinary and human regenerative medicine CRO, used its extensive experience, FDA master files, and database of veterinary stem cell therapy to secure FDA approval of a human IND for stem cell therapy in patients with osteoarthritis.

2019-08-06 --

VetStem Biopharma has long been a leader in veterinary stem cell manufacturing with clinical, regulatory and GMP manufacturing experience. In November it spun out a human regenerative medicine subsidiary, Personalized Stem Cells, Inc. (PSC). With extensive regulatory experience and one of the first cGMP cell manufacturing facilities in California, VetStem signed a contract for regulatory advisement, clinical trial management, and manufacturing of stem cells for use in PSC’s Phase I and Phase II FDA human studies. VetStem’s cGMP cleanroom facility has been inspected by the FDA and is licensed by the California Department of Public Health for human drug manufacturing.

Based on their vast experience and the use of their FDA master files and database of veterinary stem cell therapy, VetStem made the application to FDA on behalf of PSC to secure FDA approval of a human IND for stem cell therapy in patients with osteoarthritis. This FDA-IND approval to conduct clinical trials came a mere eight months after the founding of PSC and demonstrates that the use of real-world veterinary data can accelerate development. VetStem has data on over 17,000 veterinary stem cell patients and has GCP, GMP, and GLP experience.

“The rapid approval of PSC’s first IND was only possible by leveraging the experience and resources of VetStem. Our plans for expanding the scope of our clinical trials can only be accomplished with a responsive and experienced CRO/CMO” said Michael Dale, CEO of Personalized Stem Cells.

VetStem CEO, Dr. Robert Harman, stated, “PSC is a private company built on science and research and we are honored to be their regulatory and clinical CRO for their FDA trials and to manufacture their cell therapy products. This again demonstrates the close link between human and veterinary medicine and how together we can more rapidly advance the development of essential new cellular drugs. Our growth in human cell therapy contract manufacturing continues with this key contract. VetStem offers IND development services to human biopharma companies in the cell therapy field.”