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Proof-of-concept trial of an amniotic fluid-derived extracellular vesicle biologic for treating high risk patients with mild-to-moderate acute COVID-19 infection.
Bellio, Michael A; Bennett, Cassie; Arango, Alissa; Khan, Aisha; Xu, Xiumin; Barrera, Cesar; Friedewald, Vincent; Mitrani, Maria Ines.
  • Bellio MA; Organicell Regenerative Medicine, Miami, FL 33136, United States.
  • Bennett C; Organicell Regenerative Medicine, Miami, FL 33136, United States.
  • Arango A; Organicell Regenerative Medicine, Miami, FL 33136, United States.
  • Khan A; Assure Immune LLC., Miami, FL 33136, United States.
  • Xu X; Assure Immune LLC., Miami, FL 33136, United States.
  • Barrera C; United Memorial Medical Center, Houston, TX 77091, United States.
  • Friedewald V; United Memorial Medical Center, Houston, TX 77091, United States.
  • Mitrani MI; Organicell Regenerative Medicine, Miami, FL 33136, United States.
Biomater Biosyst ; 4: 100031, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1540385
ABSTRACT
A pandemic brought on by COVID-19 has created a scalable health crisis. The search to help alleviate COVID-19-related complications through therapeutics has become a necessity. Zofin is an investigational, acellular biologic derived from full-term perinatal amniotic fluid that contains extracellular vesicles. Extracellular nanoparticles as such have been studied for their immunomodulatory benefits via cellular therapeutics and, if applied to COVID-19-related inflammation, could benefit patient outcome. Subjects (n = 8) experiencing mild-to-moderate COVID-19 symptoms were treated with the experimental intervention. Complete blood count, complete metabolic panel, inflammatory biomarkers, and absolute lymphocyte counts were recorded prior to and on days 4, 8, 14, 21, and 30 as markers of disease progression. Additionally, chest x-rays were taken of the patients prior to and on days 8 and 30. Patients experienced no serious adverse events. All COVID-19-associated symptoms resolved or became stable with no indication of disease worsening as found by patient and chest x-ray reports. Inflammatory biomarkers (CRP, IL-6, TNF- α ) and absolute lymphocyte counts improved throughout the study period. Findings from a proof-of-concept, expanded access trial for COVID-19 patients prove the acellular biologic is safe and potentially effective to prevent disease progression in a high-risk COVID-19 population with mild-to-moderate symptoms.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Biomater Biosyst Year: 2021 Document Type: Article Affiliation country: J.bbiosy.2021.100031

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Biomater Biosyst Year: 2021 Document Type: Article Affiliation country: J.bbiosy.2021.100031