Randomized Double-Blind Phase 2 Study of Allogeneic HB-adMSCs for the Treatment of Chronic Post-COVID-19 Syndrome
This study will enroll up to 80 subjects with Chronic Post COVID-19 Syndrome. Subjects will receive four intravenous injections of either allogeneic HB-adMSC's or a placebo over 10 weeks with two follow-up visits and an end of study visit at week 26.
- Post COVID-19 Syndrome
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Male and female participants 18 - 70 years of age. 2. Participants in the study have proof of Post COVID-19 Syndrome in their medical records. 3. Study participants must have been diagnosed with Chronic post-COVID-19 syndrome for at least twelve weeks before enrollment in the clinical trial. 4. 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. 5. Study participants should be able to read, understand, and provide written consent. 6. Female study participants should not be pregnant or plan to become pregnant during study participation and six months after the last investigational product administration. 7. 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. * 8. The study participant is able and willing to comply with the requirements of this clinical trial.
- The subject is unable to provide informed consent or to comply with study requirements. 2. 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. 3. 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. 4. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take adequate contraceptive measures. * 5. The study participant has a history of addiction or dependency, or he or she is currently abusing or using substances. 6. Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma. 7. 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 < 59mL/min/1.73m2. - Heart Failure Presence of New York Heart Association (NYHA) Class III/IV heart failure during the screening visit. - Myocardial Infarction 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. - High Blood Pressure Medical history of uncontrolled high blood pressure is defined as a deficient standard of care treatment or blood pressure > 180/120 mm/Hg during the screening visit. - Other diseases Medical history of inherited thrombophilias, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach). - Other conditions Lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur or recent major general surgery (within 12 months before the Screening). 8. Study participant has received any stem cell treatment within 12 months before the first dose of the investigational product other than stem cells produced by Hope Biosciences. 9. The study participant has received an experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations) 10. Study participant has a laboratory abnormality during screening, including the following: - White blood cell count < 3000/mm3 - Platelet count < 80,000mm3 - Absolute neutrophil count < 1500/mm3 - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5 - The study participant has any other laboratory abnormality or medical condition that, in the investigator's opinion, poses a safety risk or will prevent the subject from completing the study. 11. The study participant has any known ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, syphilis infections, hepatitis B surface antigen-positive, or hepatitis C PCR positivity. 12. The study participant is unlikely to complete the study or adhere to the study procedures. 13. The study participant has a previously diagnosed psychiatric condition that may affect self-assessments in the investigator's opinion. 14. Study participants with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days before the first dose of the investigational product. 15. Male study participants expect to donate sperm during the trial or within six months after the last dose. Female patients intend to donate eggs or have IVF treatment during the trial or within six months after the last dose. 16. Study participants who the Investigator determines to be unsuitable for study enrollment for other reasons. 17. The subject has recently been diagnosed with an unstable Chronic obstructive pulmonary disease (COPD) as defined by patients who experience frequent or severe exacerbations and a faster decline in pulmonary function.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized Double-Blind
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Amber bags will be used to 'blind' the participant and investigator to which group the subject belongs in.
|HB-ad MSC's allogeneic||
|Sterile Normal Saline||
Sugar Land, Texas 77478
Sherry Diers, RN
- NCT ID
- Hope Biosciences Stem Cell Research Foundation
Study ContactSherry Diers, RN
Active Product: HB- adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells - allogeneic) Dose: 200 million Route: Intravenous Regimen: Weeks 0, 2, 6, and 10. Placebo: Saline Solution 0.9% Dose: N/A Route: Intravenous Regimen: Weeks 0, 2, 6, and 10.Duration of administration 1 hour Laboratory Samples. Screening, Week 0, 6, and 26. Visits by Weeks Screening Week 0 - Infusion 1 Week 2 - Infusion 2 Week 6 - Infusion 3 Week 10 - Infusion 4 Week 14 - Follow Up 1 Week 20 - Follow Up 2 Week 26 - End of Study