Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome
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
1 other identifier
expanded_access
N/A
1 country
1
Brief 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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedSeptember 29, 2025
September 1, 2025
March 11, 2021
September 24, 2025
Conditions
Keywords
Interventions
Autologous adipose derived mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- 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).
- 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.
- Subject must have previously banked their cells at Hope Biosciences, LLC.
- +2 more criteria
You may not qualify if:
- 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:
- 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).
- Subject has received any stem cell treatment within 12 months before first dose of investigational product.
- Subject has laboratory abnormalities during screening, including the following:
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, 77478, United States
Related Publications (1)
Vij R, Kim H, Park H, Cheng T, Lotfi D, Chang D. Adipose-derived, autologous mesenchymal stem cell therapy for patients with post-COVID-19 syndrome: an intermediate-size expanded access program. Stem Cell Res Ther. 2023 Oct 5;14(1):287. doi: 10.1186/s13287-023-03522-1.
PMID: 37798650RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thanh Cheng, MD
Hope Biosciences Stem Cell Research Foundation
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 15, 2021
Last Updated
September 29, 2025
Record last verified: 2025-09