Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER)

Exclusion Criteria

• •1. Patient receiving Extracorporeal Membrane Oxygenation (ECMO).
• •2. History of malignancy within previous 2.5 years, except for curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ, or cervical carcinoma.
• •3. Prior positive test for any of the following without demonstration of resolution.
• •i. Hepatitis B virus (HBV) surface antigen (HBsAg). ii. Viremic hepatitis C virus (HCV). iii. Human immunodeficiency virus-1 or -2 (HIV1 or 2 HIV2). iv. Human T-cell leukemia virus-I or -II (HTLV-I or HTLV-II). v. Syphilis.
• •4. Female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception.
• •5. Known hypersensitivity to dimethyl sulfoxide (DMSO).
• •6. Be an organ transplant recipient, other than for corneal, bone, skin, ligament, or tendon transplant.
• •7. Actively listing (or expected listing) for transplant of any organ, other than for corneal, bone, skin, ligament, or tendon transplant.
• •8. Continuous use of any medication at immunosuppressive dosing for greater than 14 consecutive days over the past 3 months.
• •9. Currently participating in an investigational therapeutic or device trial, or have participated in an investigational therapeutic or device trial within the previous 30 days, or participate in any other clinical trial for the duration of the time that the subject actively participates in this trial. However, use of hydroxychloroquine, remdesivir, lopinavir/ritonavir and ivermectin are allowed as well as convalescent plasma.. Exceptions for other experimental interventions related to treating the patient's acute illness may be made with prior approval of Longeveron.
• •10. Any serious comorbid illness or any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study, or that may compromise the validity of the study.