Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome

This is an expanded access trial for Post COVID-19 Syndrome focused on measuring Long Haul COVID-19, COVID-19, SARS-CoV-2, Long Haulers, Stem Cells, MSCs, Mesenchymal Stem Cells, COVID, Post COVID Read More

Inclusion Criteria:

1. Subject is between the ages of 18-65 years at the time of signing the informed consent form.
2. Subject has had a positive SARS-COV-02 test (preferably PCR) within the last 12 months or has been diagnosed presumptive positive and has been treated for COVID-19 within the last 12 months.
3. Subject have not fully recovered from COVID-19 in weeks or months despite a negative Sars-COV-02 test and has been diagnosed with Post COVID-19 syndrome.

4. Subject is experiencing 2 or more symptoms for over 12 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms, or dramatic worsening of symptoms i.e., subject didn't have symptoms, and had not sought medical treatment for the symptomsprior to COVID-19, or the symptoms are dramatically worse (in severity and frequency).

   • Extreme fatigue - feeling overtired with low energy and a strong desire to sleep.
   • Shortness of breath - (dyspnea) a feeling of being winded, difficulty in breathing, or a hunger for air.
   • Cough - hacking, or dry barking sound lingering dry or wet.
   • Brain fog -a diminished mental capacity marked by the inability to concentrate or to think or reason clearly that interferes with daily activities.
   • Headache - Sharp or dull reoccurring or intermittent that were not present pre-illness
   • Body aches - muscle soreness or generalized achiness throughout the body.
   • Joint pain - pain in the joints due to inflammation not experienced before illness.
   • Chest pain - (angina) feeling pressure, fullness, or tightness in your chest
   • Sleep issues - any sleep disturbances in sleep quality that makes sleep see inadequate or unrefreshing like insomnia or hypersomnia.
   • Loss of Taste/Smell - Diminished sense of taste or smell.
5. Subject must have previously banked their cells at Hope Biosciences, LLC.
6. Subject and sexual partner if woman of childbearing potential must use a least 1 highly effective form of birth control* throughout the study and for 6 months after the last dose of the investigational product.

(*Highly methods of birth control include, true sexual abstinence, bilateral tubal ligation, vasectomy, intrauterine. device and hormonal contraceptive methods.)

Exclusion Criteria:

1. Subject is unable to provide informed consent or to comply with study requirements.
2. Subject has currently been diagnosed with active COVID-19 disease.
3. Subjects unwilling to agree to the use of acceptable methods of contraception throughout the study and for 6 months after the last dose of the investigational product.
4. Pregnant or Breast-feeding women.
5. Subject has known alcoholic addiction or dependency, uses alcohol daily, or has current substance use or abuse.
6. Subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma, or melanoma.

7. Subject has 1 or more significant concurrent medical conditions (verified by medical records), including the following:

   • Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose >130mg/dl during screening visit.
   • Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR < 59mL/min/1.73m2.
   • Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit. (Appendices E)
   • Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina.
   • Medical history of uncontrolled high blood pressure defined deficient standard of care treatment and/or blood pressure > 180/120 mm/Hg during screening visit.
   • Medical history of inherited thrombophilias, recent major general surgery, lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips, femur, cancer of the lung, brain, lymphoma, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach).
8. Subject has received any stem cell treatment within 12 months before first dose of investigational product.

9. Subject has laboratory abnormalities during screening, including the following:

   • White blood cell count < 3000/mm3
   • Platelet count < 125,000mm3
   • Absolute neutrophil count < 1500/mm3
   • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN) x 1.5
   • Subject has any other laboratory abnormality, which, in the opinion of the investigator poses a safety risk or will prevent the subject for completing the study.
10. Subject is unlikely to complete the study or adhere to the study procedures.
11. Subject has a preexisting lung condition such as Chronic obstructive pulmonary disease (COPD).
12. Subjects with HIV, Hepatitis B and Hepatitis C.
13. Subject has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.