Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

September 24, 2025 updated by: Hope Biosciences Research Foundation

A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to treat COVID-19 patients. 100 patients will be enrolled. Eligible participants are suspected to have COVID-19 and consent to participate. The primary endpoints of this study are to detect change from baseline in inflammatory markers (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77091
        • United Memorial Medical Center
      • Houston, Texas, United States, 77027
        • River Oaks Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men, and women, over 18 years of age inclusively.
  2. Patient is suspected to have COVID-19 infection.
  3. Provides consent or consent is given by their legally authorized representative (LAR).
  4. Agrees to the collection of venous blood per protocol.
  5. Women of childbearing potential (WOCBP) and men (if their sexual partners are WOCBP) must use at least 1 highly effective form of birth control throughout the study and for 6 months after the last dose of study treatment. Highly effective methods of birth control include true sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk, in line with the preferred and usual lifestyle of the patient), surgery (bilateral tubal ligation or occlusion, vasectomized partner), progestogen-only or estrogen/progestogen hormonal contraceptive associated with inhibition of ovulation (oral, patch, injectable, implantable, or intravaginal), intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

Exclusion Criteria:

  1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures, in women of childbearing age. Absence of pregnancy will be confirmed through urine pregnancy test.
  2. Patients who have participated or are participating in a clinical trial of an experimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30 days.
  3. Inability to provide informed consent or to comply with study requirements.

  4. Patients with the following concomitant or past medical history:

    • Both Hypertension and Diabetes Mellitus.
    • Both Hypertension and Chronic Kidney Disease.
    • Both Diabetes Mellitus and Chronic Kidney Disease.
  5. History or evidence of alcohol abuse.
  6. History or evidence of consumption of illicit drugs.
  7. Patients requiring mechanical ventilation.
  8. Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.
  9. Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HB-adMSCs
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
Biological: HB-adMSC
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
Placebo Comparator: Placebo
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Other: Placebo
Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumor Necrosis Factor-Alpha (TNF-alpha)
Time Frame: Day 0, 3, 7, and 10
Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)
Day 0, 3, 7, and 10
Interleukin-10 (IL-10)
Time Frame: Day 0, 3, 7, and 10
Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)
Day 0, 3, 7, and 10
Interleukin-6 (IL-6)
Time Frame: Day 0, 3, 7, and 10
Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)
Day 0, 3, 7, and 10
C-Reactive Protein (CRP)
Time Frame: Day 0, 3, 7, and 10
Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)
Day 0, 3, 7, and 10
Oxygenation
Time Frame: Day 0, 3, 7, and 10
Change from baseline Oxygenation (%) in the blood
Day 0, 3, 7, and 10
Return To Room Air (RTRA)
Time Frame: Day 0, 3, 7, and 10
Number of participants who returned to room air
Day 0, 3, 7, and 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
D-dimer
Time Frame: Day 0, 3, 7, and Day 10
Change from baseline in D-dimer in the blood (mg/L)
Day 0, 3, 7, and Day 10
Myoglobin
Time Frame: Day 0, 3 7, and 10
Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)
Day 0, 3 7, and 10
Troponin
Time Frame: Day 0, 3, 7, and 10
Clinical lab evaluation of level of Troponin in the blood (ng/mL)
Day 0, 3, 7, and 10
Creatinine Kinase MB (CK-MB)
Time Frame: Day 0, 3, 7, and 10
Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)
Day 0, 3, 7, and 10
Serum Ferritin
Time Frame: Day 0, 3, 7, and 10
Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)
Day 0, 3, 7, and 10
NK Cell Surface Antigen (CD3-CD56+)
Time Frame: Day 0, 3, 7, and 10
Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)
Day 0, 3, 7, and 10
CD4+/CD8+ Ratio
Time Frame: Day 0, 3, 7, and 10
Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood
Day 0, 3, 7, and 10
7-Point Ordinal Scale
Time Frame: Day 0, 3, 7, 10, and 28 (End of Study)
Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities.
Day 0, 3, 7, 10, and 28 (End of Study)
Computed Tomography (CT) Score
Time Frame: Day 0 and Day 28
Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.
Day 0 and Day 28
Chest X-Ray Score
Time Frame: Day 0, Day 28
Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.
Day 0, Day 28
Glucose
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Glucose in the blood (mg/dL)
Screening, Day 0, 3, 7, and 10
Blood Urea Nitrogen (BUN)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)
Screening, Day 0, 3, 7, and 10
Estimated Glomerular Filtration Rate (eGFR) if Non-African American
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73)
Screening, Day 0, 3, 7, and 10
Estimated Glomerular Filtration Rate (eGFR) if African American
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73)
Screening, Day 0, 3, 7, and 10
BUN/Creatinine Ratio
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of BUN/Creatinine Ratio in the blood
Screening, Day 0, 3, 7, and 10
Sodium
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Sodium in the blood (mmol/L)
Screening, Day 0, 3, 7, and 10
Potassium
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Potassium in the blood (mmol/L)
Screening, Day 0, 3, 7, and 10
Chloride
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Chloride in the blood (mmol/L)
Screening, Day 0, 3, 7, and 10
Carbon Dioxide Total
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)
Screening, Day 0, 3, 7, and 10
Calcium
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Calcium in the blood (mg/dL)
Screening, Day 0, 3, 7, and 10
Protein Total
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of total level of Protein in the blood (g/dL)
Screening, Day 0, 3, 7, and 10
Albumin
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Albumin in the blood (g/dL)
Screening, Day 0, 3, 7, and 10
Globulin Total
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of the total level of Globulin in the blood (g/dL)
Screening, Day 0, 3, 7, and 10
Albumin/Globulin (A/G) Ratio
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood
Screening, Day 0, 3, 7, and 10
Bilirubin Total
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)
Screening, Day 0, 3, 7, and 10
Alkaline Phosphatase
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)
Screening, Day 0, 3, 7, and 10
Aspartate Aminotransferase (SGOT)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)
Screening, Day 0, 3, 7, and 10
Alanine Aminotransferase (SGPT)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)
Screening, Day 0, 3, 7, and 10
White Blood Count (WBC)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10^3/uL)
Screening, Day 0, 3, 7, and 10
Red Blood Cell (RBC) Count
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10^3/uL)
Screening, Day 0, 3, 7, and 10
Hemoglobin
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)
Screening, Day 0, 3, 7, and 10
Hematocrit
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Hematocrit in the blood (%)
Screening, Day 0, 3, 7, and 10
Mean Corpuscular Volume (MCV)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)
Screening, Day 0, 3, 7, and 10
Mean Corpuscular Hemoglobin (MCH)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)
Screening, Day 0, 3, 7, and 10
Mean Corpuscular Hemoglobin Concentration (MCHC)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)
Screening, Day 0, 3, 7, and 10
Red Cell Distribution Width (RDW)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)
Screening, Day 0, 3, 7, and 10
Platelets
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Platelets in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
Neutrophils
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Neutrophils in the blood (%)
Screening, Day 0, 3, 7, and 10
Lymphocytes
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Lymphocytes in the blood (%)
Screening, Day 0, 3, 7, and 10
Monocytes
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Monocytes in the blood (%)
Screening, Day 0, 3, 7, and 10
Eosinophils
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Eosinophils n the blood (%)
Screening, Day 0, 3, 7, and 10
Basophils
Time Frame: Screening, Day 0, 3, 7 and 10
Clinical lab evaluation of level of Basophils in the blood (%)
Screening, Day 0, 3, 7 and 10
Absolute Neutrophils
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
Absolute Lymphocytes
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
Absolute Monocytes
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
Absolute Eosinophils
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
Absolute Basophils
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
Immature Granulocytes
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Immature Granulocytes in the blood (%)
Screening, Day 0, 3, 7, and 10
Absolute Immature Granulocytes
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10^3/uL)
Screening, Day 0, 3, 7, and 10
International Normalized Ratio (INR)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of International Normalized Ratio (INR)
Screening, Day 0, 3, 7, and 10
Prothrombin Time (PT)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of Prothrombin Time (seconds)
Screening, Day 0, 3, 7, and 10
Partial Thromboplastin Time (PTT)
Time Frame: Screening, Day 0, 3, 7, and 10
Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)
Screening, Day 0, 3, 7, and 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hope Biosciences Research Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United Memorial Medical Center
River Oaks Hospital and Clinics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajiv Thakur, MD, River Oaks Hospital and Clinics
  • Principal Investigator: Joseph Gathe, MD, United Memorial Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HBCOV03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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