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Coronavirus Disease 2019 (COVID-19)Phase 1/2SENTAD-COVIDNCT04473170

Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19

A Phase 1/2 study testing Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) in people with Coronavirus Disease 2019 (COVID-19), run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Disease 2019 (COVID-19)
What is being tested?
Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteUnited Arab Emirates
Study dates
4 Apr 2020to 14 Jul 2020
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • RT-PCR Laboratory confirmation of COVID-19.
  • Male or female aged ≥ 18 years.
  • Interstitial lung change ≥ 3 judged by "Lungs Lobar based scoring" according to computed tomography (CT) scans.
  • Hospitalized and symptomatic patients, referring one or more of the following symptoms (fever, cough, or shortness of breath), in association with (at least one): tiredness, runny nose, headache, sore throat, chills, muscle pain, or new loss of taste or smell).
  • Ability to comply with test requirements and peripheral blood stem cells collection.
  • The patient or legal representative agrees to participate in the study, and signs the SENTAD-COVID Study informed consent form.

Who cannot join

  • Pediatric patients (aged < 18 years).
  • Diagnosis of any kind of shock.
  • Organ transplants in the past 3 months.
  • Patients receiving immunosuppressive therapy.
  • Diagnostic of Hepatitis B Virus (HBV) infection.
  • Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS).
Show all 12Show fewer
  • Current diagnosis of cancer.
  • History of malignancies in the past 5 years.
  • Pregnant or lactating women.
  • Have participated in other clinical trials in the past 3 months.
  • Inability to comply with test requirements and peripheral blood stem cells collection.
  • Inability to provide informed consent.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • Abu Dhabi Stem Cells Center

    Abu Dhabi, 4600

Other trials in United Arab Emirates

About this study

Official title: Adaptive Open-label Study Evaluating the Safety and Efficacy of Autologous Non- Hematopoietic Peripheral Blood Stem Cells Therapy in COVID-19 Outbreak in Abu Dhabi, 2020 (SENTAD-COVID Study)

SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were randomly allocated in a parallel assignment involving two groups of participants: Group A (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19 standard care. Standard care is defined as per the "UAE National Guidelines for Clinical Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell processing and investigational product formulation were completed by Abu Dhabi Stem Cells Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).

Read the detailed description

Group A patients received autologous NHPBSC therapy through jet nebulization, in addition to the standard care, while Group B (No investigational intervention arm) received only the UAE approved standard care. The primary endpoints were the safety and efficacy assessment, measured as Adverse Reactions (ARs) incidence [according to World Health Organization - Uppsala Monitoring Centre (WHO-UMC) causality assessment system], rate of mortality within 28-days, and the time to clinical improvement of 2 points on a seven-category ordinal scale or discharge from the Hospital, whichever came first. Immune response profile, acute-phase serum markers, and coagulation testing profile were evaluated as well, before treatment (baseline - Day 0), at Day 14, and Day 21 (in patients with early response, defined as 2 points of difference in the clinical critical treatment index within 7 days of treatment, the assessment will be performed at Day 7). The trial was approved by the institutional ADSCC Research Ethics Committees (REC), and the Emirates Institutional Review Board (IRB) for COVID-19 Research and the written informed consent was obtained from all patients or from the patient's legal representative if the patient was too unwell to provide consent. SENTAD-COVID Study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice (GCP) Guidelines of the International Conference on Harmonization (ICH). The authors were responsible for designing the trial and for compiling and analyzing the data.

Being tested
Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC), COVID-19 standard care
Keywords
COVID-19, Non-Hematopoietic Peripheral Blood Stem Cells
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)Biological

    Also called UAECell19

    SENTAD-COVID Study intervention consists of Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy through jet nebulization in addition to standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry.

  • COVID-19 standard careDrug

    Also called Current COVID-19 standard care in the UAE

    UAE National Guidelines for Clinical Management and Treatment of COVID-19.

Study groups in NCT04473170
Study groupRoleWhat they receive
Group AExperimentalAutologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.
Receives: Biological: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)
Group BActive comparatorCOVID-19 Standard care.
Receives: Drug: COVID-19 standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse reactions incidence.

    Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.

    Measured: Day 0 - 28

  2. Rate of mortality within 28-days.

    Incidence of deaths within 28-days in enrolled patients.

    Measured: Day 0 - 28

  3. Time to clinical improvement on a seven-category ordinal scale.

    Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.

    Measured: Day 0 - 28

Secondary outcomes (2)

  1. Assessment of the immune response profile.

    Immune response profile characterized according the biomarkers: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, HLA-DR, IgD, and TCRγδ, for the identification of immune cells and subsets analysis; and the humoral Immune profile: IgG, IgA, IgM levels.

    Measured: Days 0, 14, and 28

  2. Assessment of acute-phase serum markers.

    Complete Blood Counts (CBC), Acute phase proteins and Inflammatory markers: CRP, ESR, LDH, Procalcitonin (PCT), Ceruloplasmin, Haptoglobin, alpha 1 antitrypsin, IL-6, ferritin C3, PT, fibrinogen and D-dimer.

    Measured: Days 0, 14, and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2020
  2. Study start4 Apr 2020
  3. Primary completion20 May 2020
  4. Study completion14 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment involving two groups of participants: * Group A (Experimental arm): Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care. * Group B (No investigational intervention arm): COVID-19 standard care.
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04473170
Sponsor's protocol ID
CT.001.1.0.SENTAD-COVID
Acronym
SENTAD-COVID
Status last verified
Jul 2020
First submitted
14 Jul 2020
Last updated
16 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Castillo Aleman YM, Villegas Valverde CA, Ventura Carmenate Y, Abdel Hadi L, Rivero Jimenez RA, Rezgui R, Alagha SH, Shamat S, Bencomo Hernandez AA. Viability assessment of human peripheral blood-derived stem cells after three methods of nebulization. Am J Stem Cells. 2021 Oct 15;10(4):68-78. eCollection 2021.

    PubMed 34849303

  • Ventura-Carmenate Y, Alkaabi FM, Castillo-Aleman YM, Villegas-Valverde CA, Ahmed YM, Sanna P, Almarzooqi AA, Abdelrazik A, Torres-Zambrano GM, Wade-Mateo M, Quesada-Saliba D, Abdel Hadi L, Bencomo-Hernandez AA, Rivero-Jimenez RA. Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020. Transl Med Commun. 2021;6(1):25. doi: 10.1186/s41231-021-00101-5. Epub 2021 Nov 3.

    PubMed 34746417

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) in people with Coronavirus Disease 2019 (COVID-19), run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.

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 6 inclusion and 12 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: finished, as of the sponsor's last update on 16 Jul 2020. 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 Arab Emirates. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Adverse reactions incidence. (time frame: Day 0 - 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04473170, which also lists 2 linked publications.

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 16 Jul 2020.

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