NO_LONGER_AVAILABLENot Applicable

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

United States

Plain-language summary

This is an Intermediate- Size Patient Population Expanded Access Protocol to evaluate the safety and efficacy of HB-adMSCs for the treatment of patients with Post-COVID-19 Syndrome. The investigational product will be an add-on treatment to the standard of care.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Subject is between the ages of 18-65 years at the time of signing the informed consent form.
✓. 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.
✓. 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.
✓. 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).
✓. Subject must have previously banked their cells at Hope Biosciences, LLC.
✓. 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.

Exclusion criteria

✕. Subject is unable to provide informed consent or to comply with study requirements.
✕. Subject has currently been diagnosed with active COVID-19 disease.
✕. 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.
✕. Pregnant or Breast-feeding women.
✕. Subject has known alcoholic addiction or dependency, uses alcohol daily, or has current substance use or abuse.
✕. Subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
✕. Subject has 1 or more significant concurrent medical conditions (verified by medical records), including the following:
✕. Subject has received any stem cell treatment within 12 months before first dose of investigational product.

Trial details

NCT IDNCT04798066

SponsorHope Biosciences Research Foundation

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Post COVID-19 Syndrome trials