Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome

Inclusion Criteria

A study participant will be eligible for inclusion in this study only if all the following criteria apply:

1 Male and female participants 18 - 70 years of age.

• Participants in the study have proof of Post COVID-19 Syndrome in their medical records.
• Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial.
• The study participant is experiencing one or more neurological symptoms for at least 12 weeks, either continually or intermittently, with relapses not experienced pre-illness that interferes with regular daily activities. Symptoms must be new symptoms or dramatic worsening of preexisting symptoms, i.e., the subject didn't have symptoms and had not sought medical treatment for the symptoms before COVID-19, or the symptoms are dramatically worse (in severity and frequency). At least one symptom must have a severity of "5cm" on the neurological symptom VAS at screening. See the list of symptoms below:
• Extreme fatigue: Feeling overtired with low energy and a strong desire to sleep.
• Brain Fog: A diminished mental capacity marked by the inability to concentrate, think or reason clearly interferes with daily activities.
• Headache: Sharp or dull reoccurring or intermittent that were not present pre-illness.
• Sleep Issues: Any sleep disturbances in sleep quality that makes sleep seem inadequate or unrefreshing like insomnia or hypersomnia.
• Loss of Taste/Smell: A diminished sense of taste or smell.
• Study participants should be able to read, understand, and provide written consent.
• Female study participants should not be pregnant or plan to become pregnant during study participation and six months after the last investigational product administration.
• If their sexual partners can become pregnant, male participants should use a method of contraception during study participation and for six months after the last administration of the experimental drug. *
• The study participant is able and willing to comply with the requirements of this clinical trial.

Exclusion Criteria

A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:

• The subject is unable to provide informed consent or to comply with study requirements.
• A study participant has currently been diagnosed with active COVID-19 disease, defined as ongoing symptoms related to acute infection (such as fever or chills, cough, shortness of breath, or difficulty breathing, among other symptoms), and evidence of a positive RT-PCR SARS- CoV-2.
• The subject is unwilling to agree to the use of acceptable methods of contraception * throughout the study and for six months after the last dose of the investigational product.
• Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take adequate contraceptive measures. *
• The study participant has a history of addiction or dependency, or he or she is currently abusing or using substances.
• Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
• The study participant has one or more significant concurrent medical conditions (verified by medical records), including the following:
• Diabetes Mellitus (DM) Poorly controlled diabetes mellitus (PCDM), defined as a history of deficient standard of care treatment or pre-prandial glucose >130mg/dl during screening visit or post-prandial glucose >200mg/dl.
• Chronic kidney disease (CKD): Medical History of Chronic kidney disease (CKD) diagnosis or screening results of eGFR 140/90 mm/Hg during the screening visit in a patient taking anti-hypertensive treatment. At screening visit, all patients must have a blood pressure 12.0 K/UL
• Platelet count 450 K/UL
• Absolute neutrophil count 7.50 K/UL
• Alanine aminotransferase (ALT) of > 75 U/L
• Aspartate aminotransferase (AST) of > 7