Post COVID-19 SyndromeNCT04798066
Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome
A study testing HB-adMSCs in people with Post COVID-19 Syndrome, run by Hope Biosciences Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID-19 Syndrome
- What is being tested?
- HB-adMSCs
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
- 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.)
Who cannot join
- 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.
Show all 24Show fewer
- 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:
- 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.
- Subject is unlikely to complete the study or adhere to the study procedures.
- Subject has a preexisting lung condition such as Chronic obstructive pulmonary disease (COPD).
- Subjects with HIV, Hepatitis B and Hepatitis C.
- Subject has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, 77478
About this study
Official title: 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
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.
Read the detailed description
Visit 1 - Screening During the screening visit, the principal investigator and/or delegated staff must provide a copy of the IRB-approved informed consent form * to the subject before performing any study procedure.
- IRB must provide a certificate action as proof of approval of the informed consent form.
The study subject should take enough time to read this essential document. If the study subject agrees to participate in the clinical trial, after reading the document, he/she must sign it. By giving his/her signature, study subject allows the principal investigator and/or designated staff to perform the following study procedures:
- Collection of medical history and demographic information.
- Collection of prior (up to a week before screening) and current medications.
- Evaluation of Inclusion and Exclusion Criteria.
- Measurement of Weight in lb. and Height in inches.
- Collection of vital signs, including respiratory rate, pulse rate, SPO2, blood pressure and body temperature.
- Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate, and urine pregnancy test if female of childbearing potential.
- Completion of Patient Questionnaires, VAS of Symptom's and Fatigue Scale.
- Physical Examination by the principal investigator.
- Adverse Events Monitoring. Within a 28-day period, all screening data should be collected and analyzed, and the principal investigator must decide whether the screened subject is eligible to participate in this Intermediate- Size Patient Population Expanded Access Protocol.
Visit 2, 3, 4*, 5 and 6. (Infusions 1, 2, 3*, 4 and 5) Throughout these visits, the principal investigator and/or delegated staff will perform the following assessments:
- Pre-Infusion Check List
- Update Medical History Form if necessary.
- Update Concomitant medications list if applicable. (no premedication necessary for the infusions)
- Measurement of Weight in lb.
- Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.
- Completion VAS of Symptom's and Fatigue Scale.
- Physical Examination by the principal investigator.
- Investigational Product Administration:
- Drug Name: HB-adMSCs
- Route: Intravenous
- Dose: 200 million.
- 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events.
- Adverse Events monitoring.
- At Visit 4/Infusion 3: Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein, Erythrocyte sedimentation rate, urine pregnancy test female of childbearing potential and Patient Questionnaire.
Visit 7 (Follow up 1/Phone call)
- Update Medical History Form if necessary.
- Update Concomitant medications list if applicable.
- Adverse Events monitoring.
Visit 8. (End of Study)
- Update Medical History Form if necessary.
- Update Concomitant medications list if applicable.
- Measurement of Weight in lb.
- Collection of vital signs, including respiratory rate, pulse rate, SPO2, blood pressure and body temperature.
- Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein, Erythrocyte sedimentation rate and urine pregnancy test if female of childbearing potential.
- Completion of Patient Questionnaires, VAS of Symptom's and Fatigue Scale.
- Physical Examination by the principal investigator.
- Adverse Events monitoring.
- Conditions
- Post COVID-19 Syndrome
- Being tested
- HB-adMSCs
- Keywords
- Long Haul COVID-19, COVID-19, SARS-CoV-2, Long Haulers, Stem Cells, MSCs, Mesenchymal Stem Cells, COVID, Post COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCsBiological
Autologous adipose derived mesenchymal stem cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thanh Cheng, MD, Principal investigator, Hope Biosciences Stem Cell Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798066
- Sponsor's protocol ID
- HBPCOV01
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
Publications
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.
PubMed 37798650
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04798066
- Acronym / sponsor ID
- HBPCOV01
- Conditions
- Post COVID-19 Syndrome
- Keywords
- Long Haul COVID-19, COVID-19, SARS-CoV-2, Long Haulers, Stem Cells, MSCs, Mesenchymal Stem Cells, COVID
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visit 1 - Screening During the screening visit, the principal investigator and/or delegated staff must provide a copy of the IRB-approved informed consent form * to the subject before performing any study procedure.
- IRB must provide a certificate action as proof of approval of the informed consent form.
The study subject should take enough time to read this essential document. If the study subject agrees to participate in the clinical trial, after reading the document, he/she must sign it. By giving his/her signature, study subject allows the principal investigator and/or designated staff to perform the following study procedures:
- Collection of medical history and demographic information.
- Collection of prior (up to a week before screening) and current medications.
- Evaluation of Inclusion and Exclusion Criteria.
- Measurement of Weight in lb. and Height in inches.
- Collection of vital signs, including respiratory rate, pulse rate, SPO2, blood pressure and body temperature.
- Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation rate, and urine pregnancy test if female of childbearing potential.
- Completion of Patient Questionnaires, VAS of Symptom's and Fatigue Scale.
- Physical Examination by the principal investigator.
- Adverse Events Monitoring. Within a 28-day period, all screening data should be collected and analyzed, and the principal investigator must decide whether the screened subject is eligible to participate in this Intermediate- Size Patient Population Expanded Access Protocol.
Visit 2, 3, 4*, 5 and 6. (Infusions 1, 2, 3*, 4 and 5) Throughout these visits, the principal investigator and/or delegated staff will perform the following assessments:
- Pre-Infusion Check List
- Update Medical History Form if necessary.
- Update Concomitant medications list if applicable. (no premedication necessary for the infusions)
- Measurement of Weight in lb.
- Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure and body temperature.
- Completion VAS of Symptom's and Fatigue Scale.
- Physical Examination by the principal investigator.
- Investigational Product Administration:
- Drug Name: HB-adMSCs
- Route: Intravenous
- Dose: 200 million.
- 24 hours telephone encounter after Investigational Product Administration to assess incidence of adverse events or serious adverse events.
- Adverse Events monitoring.
- At Visit 4/Infusion 3: Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein, Erythrocyte sedimentation rate, urine pregnancy test female of childbearing potential and Patient Questionnaire.
Visit 7 (Follow up 1/Phone call)
- Update Medical History Form if necessary.
- Update Concomitant medications list if applicable.
- Adverse Events monitoring.
Visit 8. (End of Study)
- Update Medical History Form if necessary.
- Update Concomitant medications list if applicable.
- Measurement of Weight in lb.
- Collection of vital signs, including respiratory rate, pulse rate, SPO2, blood pressure and body temperature.
- Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete Blood Count and Coagulation Panel, C - reactive protein, Erythrocyte sedimentation rate and urine pregnancy test if female of childbearing potential.
- Completion of Patient Questionnaires, VAS of Symptom's and Fatigue Scale.
- Physical Examination by the principal investigator.
- Adverse Events monitoring.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-adMSCsAutologous adipose derived mesenchymal stem cells | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Results publication: PubMed 37798650Vij 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.
- Hope Biosciences LLCLink provided by the sponsor.
- Hope Biosciences Stem Cell Research FoundationLink provided by the sponsor.
Related trials for Post COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh Cheng, MD principal investigator
Hope Biosciences Stem Cell Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB-adMSCs in people with Post COVID-19 Syndrome, run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.