ORLANDO, Florida, June 1, 2020 – Aspire Health Science, LLC (the “Company” or “Aspire”), an FDA registered cGMP manufacturing facility specialized in the research, development, and manufacturing of cell-based therapies, is thrilled to announce that it has received IND approval from the U.S. FDA to test the Company’s proprietary cellular therapy, ACT-20, against moderate to severe COVID-19 Pneumonia in a human trial.
According to the WHO Coronavirus Disease Situation 133 report (June 1, 2020), there have been over 6 million cases of COVID-19 globally, with an approximate death total of 372,000. Even more concerning, two separate studies displayed results that the average time from the first symptom to hospitalization was seven days, while the average time from the first symptom to death was only fourteen days*.
The onset pandemic of COVID-19 presented the world with a complex challenge which lacked immediately viable solutions. In the wake of this unprecedented outbreak, it provoked Aspire to leverage their existing technological infrastructure and medical expertise in developing a cellular therapy to control COVID-19 Pneumonia. The Company’s decision to pursue treatment was validated by internal scientific evaluation of recent clinical study publications conducted by research and development teams in China, showing that MSCs (Mesenchymal Stem Cells) improves the outcome of patients with COVID-19 pneumonia by possibly controlling the cytokine storm.
Aspire’s proprietary product ACT-20 is an allogeneic cryopreserved cell preparation of Mesenchymal Stem Cells (MSCs) that are ex-vivo culture expanded from human umbilical cord tissue, and the conditioned media (MSC-CM) produced from the culture of the umbilical cord derived MSCs.
With the approval by U.S. FDA to move forward with onboarding clinical sites and treatment of human subjects, it marks a tremendous milestone for Aspire that showcases the Company’s ability to execute complex challenges under difficult conditions with an extremely aggressive timeline.
In this undertaking, Aspire aims to be the intersection between cell therapy application and crisis response, providing the medical community with solutions to prevalent gaps in treatment options. With a wealth of knowledge in developing and manufacturing cell-based therapies for specialized treatments used in human trials, Aspire is exceptionally motivated to begin Phase I of ACT-20 treatments and provide the necessary support to those requiring extensive aid.
Aspire is focused on being an industry leading CDMO and is currently searching for a Biotech partner in the cell therapy space to offer additional support for effective advancement of ACT-20 through clinical trials. Aspire will continue to expand its own CDMO capabilities and extend its services to the cellular therapy and regenerative medicine community.
ABOUT ASPIRE HEALTH SCIENCE, LLC
Aspire Health Science, LLC is an FDA registered manufacturing facility specialized in development and manufacturing of cell-based therapies. Aspire provides a one-stop shop for cell-based therapy development, manufacturing, logistics, analytical testing and regulatory support, bolstered by portfolio breadth, regulatory compliance, ability to execute & implement, and industry leading expertise.
Kingsman Scientific Management Inc. provides both strategic and high-level project management to support and accelerate development of novel technologies.
CONTACT INFORMATION
Kyle Makofka, President and CEO
Aspire Health Science, LLC
Tel: (407) 420-7246
[email protected]
[email protected]
www.aspire2cure.com
REFERENCES
*https://jamanetwork.com/journals/jama/fullarticle/2761044?guestAccessKey=f61bd430-07d8-4b86-a749-bec05bfffb65
**https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25689?af=R
