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FDA backs stem cell therapy for COVID-19 under compassionate use program

By Brian Buntz | September 20, 2021

GIOSTARThe Global Institute of Stem Cell Therapy and Research (GIOSTAR) has announced that the FDA has authorized emergency use of its stem cell therapy for hospitalized COVID-19 patients.

The San Diego–based organization has offered stem cell therapy for COVID-19-related symptoms since April 2020.

“Stem cell therapy is at the forefront of the fight against COVID-19 symptoms as well as lingering long COVID-19 symptoms,” said GIOSTAR’s cofounder, chairman and chief scientific officer Dr. Anand Srivastava. “By utilizing this form of safe, minimally invasive regenerative medicine, we are able to treat the damages caused to many organs including the lung, brain, heart, kidney, liver and others.”

The compassionate use authorization will enable GIOSTAR to offer stem cell therapy on a case-by-case basis. A physician, GIOSTAR medical director and the FDA must jointly authorize the treatment.

The three parties will assess patients individually to determine if stem cell therapy is appropriate.

GIOSTAR reports that its therapy helped seven COVID-19 patients recover from the infection within 14 days after the patients received IV-based allogeneic mesenchymal stem cells. The research was published in Aging and Disease.

In separate news, the company announced a collaboration with Cellebration Life Sciences (San Diego) to research a range of autoimmune diseases as well as orthopedic injuries.

Cellebration is also working with FDA to obtain approval to use its stem cell-based treatment for type 2 diabetes.

 

 


Filed Under: Infectious Disease
Tagged With: allogeneic mesenchymal stem cells, Cellebration Life Sciences, covid-19, FDA, GIOSTAR, Global Institute of Stem Cell Therapy and Research, stem cell therapy
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at [email protected].

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