May 5, 2020: The Cure Alliance announces the start of planning for phase II of the clinical trial of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19.  Phase I began last month and continues under the strict FDA-authorized guidelines with a goal to prove safety.  The goal of phase II is to prove efficacy of the therapy which has already shown tremendous promise on over 100 patients worldwide who have received the treatment under compassionate use guidelines.  

The principle investigator leading an international team is Dr. Camillo Ricordi, Director of the Diabetes Research institute (DRI) and Cell Transplant Center at the University of Miami Miller School of Medicine. “We are very grateful to the FDA’s Center for Biologics Evaluations and Research, Office of Tissues and Advanced Therapies for their fast authorization.” 

“There is no time to waste,” said Dr. Ricordi, “patients who die from COVID-19 have a median time of just 10 days between first symptoms and death. In severe cases oxygen levels in the bloodstream drop, and the inability to breathe pushes patients towards their end very quickly; any intervention that might prevent that trajectory would be highly desirable.

The trials are both based at the University of Miami Health System and Jackson Health System in Miami, Florida. The proposed treatment is the result of a collaborative, international, academic initiative sponsored by The Cure Alliance, a non-profit group of scientists and innovators dedicated to sharing knowledge and accelerating cures for all diseases. In response to the COVID-19 pandemic, The Cure Alliance has pivoted all resources to fighting the virus. The clinical protocol has already been shared with academic institutions throughout the world. 

A new round of fund-raising is also underway to support phase II. One hundred per cent of the tax-deductible philanthropic contributions raised by The Cure Alliance (www.thecurealliance.org/donate/) will be directed to phase II and to expand manufacturing and distribution of the UC-MSC product. 

Key scientific contributors* include Giacomo Lanzoni (1), Elina Linetsky (1), Diego Correa (1), Roger Argelio Alvarez(2), Antonio Marttos (2,3), Khemraj Hirani (1), Shari Messinger Cayetano (1), Jose Guillermo Castro(2), Michael John Paidas (2), JoNell Efantis Potter (2), Xiumin Xu (1), Marilyn Glassberg (4), JianmingTan (5),  Bradley Goldstein (6), Norma Sue Kenyon (1), David Baidal (1),Rodolfo Alejandro (1), Rodrigo Vianna (2,3), Arnold Caplan (7)) and Camillo Ricordi (1,2) 

• 1) Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of
  Medicine, FL, U.S.A.
• 2) University of Miami Health System and Jackson Health System, FL, U.S.A.
• 3) Miami Transplant Institute, FL, U.S.A.
• 4) University of Arizona College of Medicine, AZ, U.S.A.
• 5) Fuzhou General Hospital, China
• 6) Duke University, Durham, NC, USA
• 7) Case Western Reserve University, Cleveland, OH, U.S.   

*updated July 24, 2020

The Cure Alliance thanks its generous donors for supporting this COVID-19 initiative, especially Barilla, the Italian food company with 29 manufacturing plants in 26 countries including the U.S.  We also thank the Diabetes Research Institute Foundation for supporting the DRI Team and the DRI cGMP Advanced Cell and Biologic Product Manufacturing Facility, that will provide the UC-MSC products used in this clinical trial. 

Shelley Ross is president of The Cure Alliance, a 501 (c)(3) non-profit organization, founded in 2009 by Dr. Camillo Ricordi.