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HBPCOV01:"Intermediate Size Expanded Access Protocol for the Treatment of Post-COVID-19 Syndrome" HBPD05: "Intermediate Size Patient Population Expanded Access IND for the Treatment of Patients With Parkinson's Disease"

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ClinicalTrials.gov Identifier: NCT04798066
Expanded Access Status : Available
First Posted : March 15, 2021
Last Update Posted : December 30, 2021
Sponsor:
Collaborator:
Hope Biosciences
Information provided by (Responsible Party):
Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )

Brief Summary:

IND 019680 - HBPCOVID01

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.

IND 027966 - HBPD05

This is an Intermediate Size Patient Population Expanded Access IND to Evaluate the Safety of autologous HB-adMSCs for the treatment of patients with Parkinson's disease.


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

Detailed Description:

IND 019680 - HBPCOVID01

The dose to use for this Intermediate- Size Patient Population Expanded Access Protocol is 200 million HB-adMSCs, administered through intravenous infusion only, with a treatment duration of 14 weeks, infusion rate 4-5ml/min and total volume of 250 ml Sodium chloride 0.9%. A total of 5 administrations and a dosing interval of two weeks for the first two HB-adMSCs administrations and one month after that.

IND 027966 - HBPD05

This expanded access program was developed to include ten patients between 76 and 95 y/o diagnosed with Parkinson's disease. The expanded access program will last for 26 weeks, during which time the eligible patients will receive six intravenous infusions of autologous Hope Biosciences adipose-derived mesenchymal stem cells. Each investigational product administration will be monitored for 2 hours at the following intervals: 0, 15, 30, 45, 60, 90, and 120 minutes. During the infusion and the follow-up visit, volunteers will be evaluated for the incidence of any serious or non-serious adverse event occurrences.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: HBPCOV01: 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. HBPD05: "An Intermediate Size Patient Population Expanded Access IND to Evaluate the Safety of Autologous HB-adMSCs for the Treatment of Patients With Parkinson's Disease"



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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

IND 019680 - HBPCOVID01

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.

IND 027966 - HBPD05

Inclusion Criteria:

  1. Patients aged 76-95 years old (male and female).
  2. Patients must have had a Parkinson's disease diagnosis for a minimum of six months before 1st infusion.
  3. Patients must have previously banked their mesenchymal stem cells with Hope Biosciences.
  4. Patients should be able to read, understand, and provide voluntarily written consent.
  5. Patients able and willing to comply with the requirements of this expanded access program.

Exclusion Criteria:

  1. Patients with advanced Parkinson's disease. Advanced PD is defined as a significant disability, wheelchair-bound or bedridden.
  2. Any malignancy or clinical evidence that supports the presence of a malignant process in a patient is being investigated. Malignancy is defined as any form of cancer that had occurred in the previous five years before the first infusion and may require surgery, chemotherapy, or radiation.
  3. Patients with medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 140/90 mm/Hg during screening visit.
  4. Patients with the following concomitant or past medical history:

    • Heart Failure - New York Heart Association (NYHA) Class III/IV.
    • Heart Attack (in the past six months before 1st infusion).
    • Stroke (in the past six months before 1st infusion).
    • Hepatitis B or C.
    • Human immunodeficiency virus (HIV) infection.
  5. Any of the following abnormal lab findings during screening will disqualify a patient from this expanded access program:

    • Hemoglobin (Hgb) <10 G/DL or >18 G/DL
    • Hematocrit (HCT) <30% or >54 %
    • Platelet count < 80 K/UL and or > 450 K/UL.
    • White blood cell count WBC < 3.0 K/UL and > 12.0 K/UL.
    • Alanine aminotransferase (ALT) of > 75 IU/L
    • Aspartate aminotransferase (AST) of > 75 IU/L
    • eGFR < 59 mL/min/1.73
    • Pre-prandial glucose > 130 MG/DL
    • Post-prandial glucose > 200 MG/DL
  6. Patients who have received any stem cell treatment in the past six months before 1st infusion other than stem cells produced by Hope Biosciences.
  7. Patients who are unlikely to complete the visits or adhere to the procedures.
  8. The patient has previously been diagnosed with a psychiatric disorder, which is currently uncontrolled.
  9. Patients with a history of addiction or dependency or currently abusing or using substances.
  10. Patients with any form of kidney dialysis will be excluded from participation in the investigation.
  11. Patients who have received an experimental drug in the past 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations).
  12. Patients who the Investigator determines to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.
  13. Patients who have recently undergone major surgery (in the past six months before 1st infusion). Some examples of major surgeries include, but are not limited to, the following: heart surgeries, aortic aneurysm bypass, organ transplant, intracranial surgery, spinal laminectomy or fusion, amputation, resection of the lung, resection of esophagus, resection of a mediastinal mass, resection of bladder or prostate tumor and resection of kidney or ureter.

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


Contacts
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Contact: Sherry Diers, RN 1-346-900-0340 ext 101 Sherry@hopebio.org
Contact: Linette Rehkopf, RPh. 1-346-900-0340 ext 102 Linette@hopebio.org

Locations
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United States, Texas
Hope Biosciences Stem Cell Research Foundation Available
Sugar Land, Texas, United States, 77478
Contact: Sherry Diers, RN    346-900-0340 ext 101    Sherry@hopebio.org   
Contact: David Gonzalez, RN    1-346-900-0340 ext 101    david@hopebio.org   
Principal Investigator: Thanh C Cheng, MD         
Principal Investigator: Djamchid Lotfi, MD         
Sponsors and Collaborators
Hope Biosciences Stem Cell Research Foundation
Hope Biosciences
Additional Information:
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Responsible Party: Hope Biosciences Stem Cell Research Foundation
ClinicalTrials.gov Identifier: NCT04798066    
Other Study ID Numbers: HBPCOV01, HBPD05
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: December 30, 2021
Last Verified: December 2021
Keywords provided by Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation ):
Long Haul COVID-19
COVID-19
SARS-CoV-2
Long Haulers
Stem Cells
Autologous MSCs
MSCs
Mesenchymal Stem Cells
PD
Additional relevant MeSH terms:
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COVID-19
Parkinson Disease
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases