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Trial record 2 of 3 for:    stem cell | long covid

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04798066
Expanded Access Status : No longer available
First Posted : March 15, 2021
Last Update Posted : August 2, 2022
Sponsor:
Collaborator:
Hope Biosciences
Information provided by (Responsible Party):
Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )

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.

Condition or disease Intervention/treatment
Post COVID-19 Syndrome Biological: HB-adMSCs

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
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.

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: HB-adMSCs
    Autologous adipose derived mesenchymal stem cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798066


Locations
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United States, Texas
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States, 77478
Sponsors and Collaborators
Hope Biosciences Stem Cell Research Foundation
Hope Biosciences
Investigators
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Principal Investigator: Thanh Cheng, MD Hope Biosciences Stem Cell Research Foundation
Additional Information:
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Responsible Party: Hope Biosciences Stem Cell Research Foundation
ClinicalTrials.gov Identifier: NCT04798066    
Other Study ID Numbers: HBPCOV01
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Keywords provided by Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation ):
Long Haul COVID-19
COVID-19
SARS-CoV-2
Long Haulers
Stem Cells
MSCs
Mesenchymal Stem Cells
COVID
Post COVID
Additional relevant MeSH terms:
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COVID-19
Pathologic Processes
Syndrome
Disease
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases